Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers
Phase: PHASE2
Conditions: Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
Sponsor: Inovio Pharmaceuticals

Official Title:    Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for 
Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy 
Volunteers 
NCT Number: 
NCT04588428 
Document Date: 
Protocol Version 2: 12-February-2021
                                Protocol Version 1: 23-March-2020

CONFIDENTIAL
Page 1 of 71 
MERS-201 
Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for 
Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy 
Volunteers  
Sponsored by: 
Inovio Pharmaceuticals, Inc. 
Protocol Version: 1.0 
Protocol Version Date: 23Mar2020

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INO-4700 
  
MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Clinical Protocol 
Protocol Version Date: 23Mar2020 
CONFIDENTIAL 
Protocol Version: v1.0 
 
Page 3 of 71 
 
 
Principal Investigator Acknowledgement 
 
I have read and understood this Protocol and agree that it contains all details necessary to 
conduct the clinical trial. I understand that it must be reviewed by the Institutional Review Board 
(IRB)/Research Ethics Board (REB)/Ethics Committee (EC) overseeing the conduct of the 
clinical trial and approved or given favorable opinion before implementation. 
 
The Principal Investigator’s (PI’s) signature constitutes the PI’s approval of this Protocol and 
provides the necessary assurances that this clinical trial will be conducted in accordance with 
International Council for Harmonization (ICH)/Good Clinical Practice (GCP), local legal and 
regulatory requirements, and all stipulations of the Protocol. 
 
 
Principal Investigator Signature: 
 
 
 
 
Principal Investigator Printed Name 
 
 
 
 
 
Principal Investigator Signature 
 
Date (ddMmmyyyy) 
 
 
 
Clinical Trial Site Number: 
 
Clinical Trial Site Name: 
 
 
 
 
 

INO-4700 
  
MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Clinical Protocol 
Protocol Version Date: 23Mar2020 
CONFIDENTIAL 
Protocol Version: v1.0 
 
Page 4 of 71 
 
Table of Contents 
Clinical Protocol Synopsis ............................................................................................................. 9 
Figure 1 – Study Design and Dosing Schema ............................................................................ 15 
Table 4 – Part 1 Trial Schedule of Events .................................................................................. 16 
Table 5 – Part 2 Trial Schedule of Events (Day 0 & Week 4 Optimal Regimen) ........................ 17 
Table 6 – Part 2 Trial Schedule of Events (Day 0 & Week 8 Optimal Regimen) ........................ 18 
1.0 
Introduction .................................................................................................................. 19 
1.1 
Background and Scientific Rationale ............................................................................ 19 
1.2 
Background Information ............................................................................................... 19 
1.2.1 
Clinical Presentation and Immune Response ........................................................ 19 
1.2.2 
Current Treatment and Unmet Need ...................................................................... 20 
1.2.3 
Emerging Health Threat ......................................................................................... 21 
1.3 
Rationale ...................................................................................................................... 21 
1.3.1 
Dose and Regimen Rationale ................................................................................ 21 
1.3.2 
DNA Vaccines ........................................................................................................ 23 
1.3.3 
Use of Electroporation with DNA Vaccines ............................................................ 23 
1.4 
Potential Benefits and Risks ......................................................................................... 24 
2.0 
Objectives and Purpose ............................................................................................... 25 
2.1 
Hypothesis .................................................................................................................... 25 
3.0 
Clinical Trial Design and Endpoints .............................................................................. 25 
3.1 
Primary Objectives ....................................................................................................... 27 
3.2 
Primary Endpoints ........................................................................................................ 27 
3.3 
Exploratory Objective ................................................................................................... 27 
3.4 
Exploratory Endpoint .................................................................................................... 27 
3.5 
Safety Assessment ....................................................................................................... 27 
3.6 
Immunogenicity Assessment ........................................................................................ 28 
4.0 
Clinical Trial Population ................................................................................................ 28 
4.1 
Inclusion Criteria ........................................................................................................... 28 
4.2 
Exclusion Criteria .......................................................................................................... 29 
4.3 
Discontinuation/Withdrawal of Clinical Trial Participants .............................................. 29 
5.0 
Clinical Trial Treatment ................................................................................................ 30 
5.1 
Investigational Products (IPs) and Study Device .......................................................... 30 
5.1.1 
INO-4700 and SSC-0001 ....................................................................................... 30 
5.1.2 
CELLECTRATM 2000 .............................................................................................. 30 
5.2 
Treatment Regimens .................................................................................................... 31 
5.2.1 
Blinding ................................................................................................................... 31 
5.3 
Packaging and Labeling ............................................................................................... 32 
5.3.1 
INO-4700 / SSC-0001 ............................................................................................ 32 

INO-4700 
  
MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Clinical Protocol 
Protocol Version Date: 23Mar2020 
CONFIDENTIAL 
Protocol Version: v1.0 
 
Page 5 of 71 
 
5.3.2 
CELLECTRATM 2000 .............................................................................................. 32 
5.4 
Handling and Storage ................................................................................................... 32 
5.4.1 
INO-4700 and SSC-0001 ....................................................................................... 32 
5.4.2 
CELLECTRATM 2000 .............................................................................................. 33 
5.5 
Preparation and Dispensing ......................................................................................... 33 
5.6 
Use of Study Device ..................................................................................................... 33 
5.7 
Investigational Drug and Study Device Accountability ................................................. 33 
5.7.1 
INO-4700 and SSC-0001 Accountability ................................................................ 33 
5.7.2 
CELLECTRATM 2000 Accountability ....................................................................... 33 
5.8 
Return and Destruction of Investigational Drug and Study Device ............................... 34 
5.8.1 
INO-4700 and SSC-0001 ....................................................................................... 34 
5.8.2 
Return of CELLECTRATM 2000 .............................................................................. 34 
6.0 
Clinical Trial Procedures and Schedule ....................................................................... 34 
6.1 
Procedure by Visit ........................................................................................................ 35 
6.1.1 
Clinical Trial Screening Evaluations ....................................................................... 35 
6.1.1.1  Medical History ....................................................................................................... 35 
6.1.2 
Clinical Trial Evaluations and Procedures .............................................................. 36 
6.1.2.1  Day 0 ...................................................................................................................... 36 
6.1.2.2  Week 2 ................................................................................................................... 36 
6.1.2.3  Week 4 ................................................................................................................... 36 
6.1.2.4  Week 6 ................................................................................................................... 37 
6.1.2.5  Week 8 ................................................................................................................... 38 
6.1.2.6  Week 10 ................................................................................................................. 39 
6.1.2.7  Week 12 ................................................................................................................. 39 
6.1.2.8  Week 30 ................................................................................................................. 39 
6.1.2.9  Week 48 ................................................................................................................. 39 
6.1.2.10 Week 50 ................................................................................................................. 40 
6.1.2.11 Week 68 ................................................................................................................. 40 
6.2 
Informed Consent ......................................................................................................... 41 
6.3 
Assignment of Subject Identification Numbers ............................................................. 41 
6.4 
Safety Evaluations ........................................................................................................ 41 
Physical Exam and Targeted Physical Assessments .......................................................... 41 
Vital Signs ............................................................................................................................ 41 
Height and Weight ............................................................................................................... 41 
12-lead ECG ........................................................................................................................ 42 
Laboratory Evaluations ........................................................................................................ 42 
6.4.1 
Injection and EP ..................................................................................................... 43 

INO-4700 
  
MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Clinical Protocol 
Protocol Version Date: 23Mar2020 
CONFIDENTIAL 
Protocol Version: v1.0 
 
Page 6 of 71 
 
6.4.2 
Management of Anxiety and Pain Due to Electroporation (EP) Procedures .......... 43 
6.4.3 
Assessment of Laboratory Abnormalities ............................................................... 43 
6.4.4 
Assessment of Clinical Trial Adverse Events (AEs) ............................................... 44 
6.4.5 
Assessment of Injection Site Reactions ................................................................. 44 
6.4.6 
Peripheral Blood Immunogenicity Assessments .................................................... 45 
6.4.7 
Concomitant Medications/Treatments .................................................................... 45 
6.4.8 
Restrictions ............................................................................................................. 45 
7.0 
Evaluation of Safety and Management of Toxicity ....................................................... 46 
7.1 
Safety Parameters ........................................................................................................ 46 
7.2 
Adverse Events (AEs) .................................................................................................. 46 
7.3 
Adverse Drug Reaction (ADR) ..................................................................................... 46 
7.4 
Serious Adverse Events (SAEs) ................................................................................... 46 
7.5 
Unexpected Adverse Drug Reaction ............................................................................ 47 
7.6 
Unanticipated (Serious) Adverse Device Effect (UADE) .............................................. 47 
7.7 
Device Deficiency ......................................................................................................... 48 
7.8 
Safety and Toxicity Management ................................................................................. 48 
7.8.1 
Adverse Event of Special Interest (AESI) ............................................................... 48 
7.8.2 
Abnormal Laboratory Value .................................................................................... 48 
7.8.3 
Clinical Trial Stopping Rules .................................................................................. 48 
7.9 
Safety Data Reporting Period, Method of Collection and Submission.......................... 49 
7.10 
Adverse Event Reporting .............................................................................................. 50 
7.10.1  Submitting the Initial Serious Adverse Event (SAE) Report Form .......................... 50 
7.10.2  Recording the Event ............................................................................................... 50 
7.10.3  Assessing Severity (Intensity) ................................................................................ 50 
7.10.4  Causal Relationship of Clinical Material to Adverse Events (AEs) ......................... 50 
7.11 
Reporting Pregnancy During the Clinical Trial .............................................................. 51 
7.12 
Reporting Device-Related Complaints or Deficiencies ................................................. 52 
7.13 
Notifying Regulatory Authorities and Institutional Review Boards (IRBs)/Research 
Ethics Boards (REBs)/Ethics Committees (ECs) of Safety Information ....................... 52 
7.13.1  Sponsor Responsibilities ........................................................................................ 52 
7.13.2  Principal Investigator (PI) Responsibilities ............................................................. 53 
7.14 
Post-Trial Reporting Requirements .............................................................................. 53 
7.15 
Clinical Trial Discontinuation ........................................................................................ 53 
8.0 
Statistical Considerations ............................................................................................. 53 
8.1 
Statistical and Analytical Plan ....................................................................................... 53 
8.2 
General Considerations ................................................................................................ 53 
8.3 
Statistical Hypotheses .................................................................................................. 54 
8.4 
Analytical Populations .................................................................................................. 54 

INO-4700 
  
MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Clinical Protocol 
Protocol Version Date: 23Mar2020 
CONFIDENTIAL 
Protocol Version: v1.0 
 
Page 7 of 71 
 
8.5 
Description of Statistical Methods ................................................................................ 54 
8.5.1 
Primary Safety Analyses ........................................................................................ 54 
8.5.2 
Primary Immunogenicity Analyses ......................................................................... 55 
8.5.3 
Safety Analyses ...................................................................................................... 55 
8.5.4 
Disposition .............................................................................................................. 56 
8.5.5 
Demographic and Other Baseline Characteristics ................................................. 56 
8.5.6 
Interim Analyses ..................................................................................................... 56 
8.5.7 
Multiplicity ............................................................................................................... 57 
8.5.8 
Missing Values ....................................................................................................... 57 
8.5.9 
Exploratory Analyses .............................................................................................. 57 
8.6 
Sample Size/Power ...................................................................................................... 57 
8.7 
Randomization and Blinding ......................................................................................... 57 
9.0 
Ethics ........................................................................................................................... 58 
9.1 
Investigator and Sponsor Responsibilities .................................................................... 58 
9.2 
Institutional Review Board (IRB)/Research Ethics Board (REB)/Ethics Committee (EC)
 ..................................................................................................................................... 58 
9.3 
Protection of Human Participants ................................................................................. 59 
9.3.1 
Compliance with Informed Consent Regulations ................................................... 59 
9.3.2 
Compliance with Institutional Review Board (IRB)/Research Ethics Board 
(REB)/Ethics Committee (EC) Requirements ......................................................... 59 
9.3.3 
Compliance with Good Clinical Practice ................................................................. 59 
9.3.4 
Compliance with Electronic Records/Signatures Regulations (21CFR Part 11) .... 59 
9.3.5 
Compliance with Protocol ....................................................................................... 59 
9.3.6 
Changes to the Protocol ......................................................................................... 59 
10.0 
Data Collection, Monitoring and Reporting................................................................... 60 
10.1 
Confidentiality and Privacy ........................................................................................... 60 
11.0 
Source Documents ....................................................................................................... 60 
11.1 
Records Retention ........................................................................................................ 60 
12.0 
Safety and Quality Monitoring ...................................................................................... 61 
12.1 
Safety Review ............................................................................................................... 61 
12.2 
Clinical Monitoring ........................................................................................................ 61 
13.0 
Financing and Insurance .............................................................................................. 62 
14.0 
Publication Policy ......................................................................................................... 62 
15.0 
List of Abbreviations ..................................................................................................... 63 
16.0 
References ................................................................................................................... 65 
17.0 
Appendices .................................................................................................................. 69 
17.1 
APPENDIX A: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers 
Enrolled in Preventive Vaccine Clinical Trial ................................................................ 69 

INO-4700 
  
MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Clinical Protocol 
Protocol Version Date: 23Mar2020 
CONFIDENTIAL 
Protocol Version: v1.0 
 
Page 8 of 71 
 
17.2 
APPENDIX B: Adverse Events of Special Interest ....................................................... 71 
 
 
 

INO-4700 
  
MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Clinical Protocol 
Protocol Version Date: 23Mar2020 
CONFIDENTIAL 
Protocol Version: v1.0 
 
Page 9 of 71 
 
CLINICAL PROTOCOL SYNOPSIS 
Protocol Title: Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for 
Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers 
Protocol Number: MERS-201 
Clinical Trial Phase: 2a 
Estimated Number of Clinical Trial Centers and Countries/Regions: Approximately nine 
(9) to ten (10) centers in the Middle East and Africa Regions. Additional sites and countries 
may be added as necessary.   
Clinical Trial Design:  
This is a Phase 2a, randomized, blinded, placebo-controlled, multi-center trial to evaluate the 
safety, tolerability and immunological profile of INO-4700 administered by intradermal (ID) 
injection followed by electroporation (EP) using the CELLECTRATM 2000 device in healthy adult 
volunteers. The primary objectives of this trial are to evaluate the tolerability, safety and 
immunogenicity of INO-4700 administered by ID injection followed by EP in healthy adult 
volunteers according to the regimens outlined in Table 1, Table 2, Table 3 and Figure 1.  
Approximately 542 healthy volunteers will be evaluated across two (2) parts of this study, Part 
1 and Part 2. INO-4700 or placebo (SSC-0001) will be administered ID in ~0.1 mL dose volume 
followed immediately by EP. 
Part 1 – Dose Finding 
In Part 1, approximately 192 participants ages 18-50 years will be assessed through five (5) 
dose levels and regimens. These five (5) dose levels and regimens will be evaluated across 
nine (9) groups designated Study Groups A, B, C, D, E, F, G, H and I. Study Groups A, B, C, 
D and E will receive INO-4700 and enroll approximately 32 participants per group. Study 
Groups F, G, H and I will receive placebo and enroll approximately 8 participants per group. 
 
Table 1: MERS-201 Part 1 Dose Groups 
 
Study 
Group 
Number of 
Participants 
Dosing 
Weeks 
Number of  
Injections + EP 
per Dosing Visit 
INO-4700 (mg) 
per injection 
Total Dose of 
INO-4700 (mg) 
Active 
A 
32 
0, 4 
1 
0.6 
1.2 
B 
32 
0, 4 
1 
1.0 
2.0 
C 
32 
0, 8 
1 
1.0 
2.0 
D 
32 
0, 8 
2a 
0.5 + 0.5 (1.0) 
2.0 
E 
32 
0, 4 
2a 
1.0 + 1.0 (2.0) 
4.0 
Total Active 
160 
 
 
 
 
Placebo 
F 
8 
0, 4 
1 
─ 
─ 
G 
8 
0, 8 
1 
─ 
─ 
H 
8 
0, 8 
2a 
─ 
─ 
I 
8 
0, 4 
2a 
─ 
─ 
Total Placebo 
32 
 
Total 
192 
 
aINO-4700 will be injected ID followed by EP in an acceptable location on two different limbs at each dosing visit 
 

INO-4700 
  
MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Clinical Protocol 
Protocol Version Date: 23Mar2020 
CONFIDENTIAL 
Protocol Version: v1.0 
 
Page 10 of 71 
 
Participants will be randomized to receive either INO-4700 or placebo according to the dosing 
schedule described in Table 1. All participants and all clinical site staff will remain blinded to 
the subject treatment allocation (i.e., INO-4700 or placebo) within each Study Group, with the 
exception of the site’s pharmacy personnel.  
Enrollment into all Study Groups will proceed in parallel. Once the first four (4) participants in 
Active Study Groups and the first two (2) participants in Placebo Study Groups have Week 2 
clinical laboratory and adverse event data available, the results will be reviewed by the Data 
Safety and Monitoring Board (DSMB) (Figure 1). Enrollment will not be paused during this 
DSMB review, and screening and randomization may continue.  
Upon completion of the Week 10 visit and availability of immunological data, Part 1 will be 
unblinded in order to allow for one regimen to be selected for advancement into Part 2. The 
Study Group with an optimal immune response, an acceptable safety profile and tolerant dosing 
regimen by Week 10, will be selected for Part 2. The Sponsor will remain blinded through Part 
1 of the study until initiation of the Week 10 data review.  
All Part 1 participants will be followed for 48 weeks from the Day 0 dosing [i.e., Week 48 will be 
the planned End of Study (EOS) visit]. 
Part 2 – Expansion   
In Part 2, approximately 350 participants will be evaluated across one (1) dose level and 
regimen as outlined in Table 2 and Table 3. The dose level and regimen will be identified based 
on the optimal dose selection from Part 1. Enrollment into Part 2 may begin following completion 
of the Week 10 optimal dose and regimen selection in Part 1 (i.e., prior to Week 48 completion 
in Part 1).  
 
Table 2: MERS-201 Part 2A Dose Groups 
Study Group 
Number of 
Participants 
Dosing Weeks 
Dose and 
Regimen 
Active  
300 
0, 4 or 8 
TBD 
Placebo 
50 
0, 4 or 8 
TBD 
Total 
350 
 
 
 
Table 3: MERS-201 Part 2B Dose Groups 
Study Group 
Number of 
Participants 
Dosing Week 
Dose and 
Regimen 
Active – Booster  
100a 
48 
TBD 
Active – Placebo 
100b 
48 
TBD 
Placebo 
25c 
48 
TBD 
Total 
225 
 
 
aFirst (Day 0), second (Week 4 or 8) and third (Week 48 booster) doses will be INO-4700.  
bFirst (Day 0) and second (Week 4 or 8) doses will be INO-4700. Third dose will be a placebo dose at Week 48. 
cPlacebos will also receive a third dose in order to maintain blinded design. First (Day 0), second (Week 4 or 8) and third (Week 
48) doses will be a placebo dose. 
TBD, to be determined based on Part 1 optimal dose and regimen selection 
In Part 2A, participants will be randomized to receive the optimal dose of active (INO-4700) 
selected in Part 1 of this study or placebo (SSC-0001) (Figure 1). Approximately 300 
participants will receive INO-4700 and 50 participants will receive placebo.  
In Part 2B, the first 200 participants are randomized to the Part 2A Active Study Group will 
receive a third dose of either INO-4700 or placebo at Week 48. Specifically, Study Group “Active 
– Booster” will receive INO-4700 at the first (Day 0), second (Week 4 or 8) and third (booster 
at Week 48) doses. Study Group “Active – Placebo” will receive INO-4700 at the first (Day 0) 

INO-4700 
  
MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Clinical Protocol 
Protocol Version Date: 23Mar2020 
CONFIDENTIAL 
Protocol Version: v1.0 
 
Page 11 of 71 
 
and second (Week 4 or 8) doses, and placebo at the third (Week 48) dose. Similarly, in Part 
2B, the first 25 participants randomized to the Part 2A Placebo Study Group will receive a third 
dose of placebo at Week 48. Collectively, these first 225 participants will be followed for 68 
weeks from the Day 0 dosing [i.e., Week 68 will be the planned End of Study (EOS) visit]. All 
remaining 125 participants in Part 2A (i.e., those receiving only 2 doses) will be followed for 48 
weeks from the Day 0 dosing [i.e., Week 48 will be the planned End of Study (EOS) visit].  
All participants and all clinical site staff will remain blinded to the subject treatment allocation 
(i.e., INO-4700 or placebo), with the exception of the site’s pharmacy personnel. Enrollment 
into Active and Placebo Study Groups will proceed in parallel. No enrollment pauses are 
planned. 
Upon completion of the Week 12 visit and availability of immunological data, group-level (INO-
4700 or placebo) unblinded summaries of immunogenicity and safety will be produced. This 
Week 12 analysis will serve to inform product development goals. The Sponsor will continue to 
remain blinded to subject-level treatment allocation (i.e., INO-4700 or placebo) for the 
remainder of the trial. 
DSMB for Parts 1 and 2 
The DSMB will remain unblinded throughout the duration of the study.  
In Part 1, the DSMB will review clinical laboratory and adverse event data for the first six (6) 
participants, 4 active and 2 placebos, in each Active and Placebo Study Group, respectively, 
once the Week 2 safety data are complete. The DSMB will again convene to review all available 
safety data for all Study Groups once approximately 50% of planned participants are enrolled 
(i.e., approximately 96 participants), and once enrollment is complete.  
Subsequently, the DSMB will convene every three (3) calendar months thereafter until study 
completion. Enrollment pauses are not planned during any DSMB review in Part 1 nor 2. 
Should the criteria for any stopping rule be met, at any time, the DSMB will be notified, and the 
study may be paused or stopped if the DSMB considers the safety data unsatisfactory. In this 
case, further enrollment and administration of INO-4700 or placebo to participants will be 
paused for further evaluation. The Sponsor will perform an investigation and consult the DSMB 
and other experts, if needed, to determine whether to resume randomization and/or dosing of 
the remainder of the participants to the study or Study Group(s).  
Criteria for Evaluation:  
Research Hypothesis: 
 
A selected optimal dose of INO-4700 delivered ID followed by EP using CELLECTRATM 
2000 in healthy volunteers will be well tolerated, exhibit an acceptable safety profile 
and result in generation of immune responses to MERS-CoV.  
Primary Objectives: 
 
Evaluate the tolerability and safety of INO-4700 administered by ID injection followed 
by EP in healthy adult volunteers 
 
Evaluate the cellular (T cell) and humoral immune response to INO-4700 administered 
by ID injection followed by EP for identification and confirmation of an optimal dose and 
regimen  
 
Evaluate selected optimal dose for safety and immunogenicity  
Primary Safety Endpoints: 

INO-4700 
  
MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Clinical Protocol 
Protocol Version Date: 23Mar2020 
CONFIDENTIAL 
Protocol Version: v1.0 
 
Page 12 of 71 
 
 
Incidence of adverse events by system organ class (SOC), preferred term (PT), 
severity and relationship to investigational product  
 
Administration (i.e., injection) site reactions (described by frequency and severity)  
 
Incidence of adverse events of special interest  
Primary Immunogenicity Endpoints: 
 
Overall immune response 
o MERS-CoV antigen specific antibodies  
o Antigen specific cytokine-producing T cell responses  
Exploratory Objective:  
 
Evaluate the expanded immunological profile by assessing both T and B cell immune 
responses 
 
Evaluate the cellular (T cell) and humoral immune response to INO-4700 administered 
by ID injection followed by EP for impact of boosting with a third dose 
Exploratory Endpoint:  
 
Expanded immunological profile which may include (but not limited to) additional 
assessment of T and B cell numbers and T and B cell molecular changes by measuring 
immunologic proteins and mRNA levels of genes of interest at all weeks as determined 
by sample availability 
Safety Assessment: 
For Part 1, adverse events will be collected at every visit and safety samples will be drawn at 
Screening, Week 2, Week 6, Week 10 and Week 48. For Part 2, adverse events will be 
collected at every visit and safety samples will be drawn at Screening, Week 2, Week 6 (if 
optimal regimen includes dosing at Week 4), Week 10 (if optimal regimen includes dosing at 
Week 8), Week 48, Week 50 (for Part 2B participants receiving three doses) and Week 68 
(for Part 2B participants receiving three doses). Refer to the Schedule of Events Table 4, 
Table 5 and Table 6 for additional details. 
For both Parts 1 and 2, all adverse events, regardless of relationship, will be collected from 
the time of consent to 12 weeks from Day 0. Only related adverse events, adverse events of 
special interest and serious adverse events will be collected thereafter. 
Additionally, for both Parts 1 and 2, a pregnancy test will be performed at screening and prior 
to each dose. 
Immunogenicity Assessment:  
For Part 1, immunology blood samples will be collected at Screening, Day 0, Week 2, Week 
6, Week 10, Week 12 and Week 48. For Part 2, immunology blood samples will be collected 
at Screening, Day 0, Week 2, Week 6 (if optimal regimen includes dosing at Week 4), Week 
10 (if optimal regimen includes dosing at Week 8), Week 12, Week 48, Week 50 (for Part 2B 
participants receiving three doses) and Week 68 (for Part 2B participants receiving three 
doses). Refer to the Schedule of Events Table 4, Table 5 and Table 6 for additional details. 
Determination of analysis of collected samples for immunological endpoints will be determined 
on an ongoing basis throughout the study. 
Clinical Trial Population: 
Part 1 – Healthy adult volunteers between the ages of 18-50 years, inclusive.  
Part 2 – Healthy adult volunteers at least 18 years of age. 

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Inclusion Criteria: 
a. Able to provide informed consent and have signed Informed Consent Form (ICF) prior 
to screening procedures; 
b. For Part 1, adults age 18 and 50 years, inclusive. For Part 2, adults at least 18 years 
of age; 
c. Judged to be healthy by the Investigator on the basis of medical history, physical 
examination and vital signs performed at Screening; Note: Participants taking daily 
prescription or non-prescription medications for management of acceptable chronic 
medical conditions must be on a stable dose, as defined by non-change in dose for the 
3 months prior to the first dose of study medication and no planned changes during the 
active dosing period of the study; 
d. Able and willing to comply with all study procedures; 
e. Screening laboratory results within normal limits for testing laboratory or deemed not 
clinically significant by the Investigator; 
f. 
Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody 
and Human Immunodeficiency Virus (HIV) antibody or rapid test at screening; 
g. Screening ECG deemed by the Investigator as having no clinically significant findings 
(e.g. Wolff-Parkinson-White syndrome); 
h. Must meet one of the following criteria with respect to reproductive capacity: 
 
Women who are post-menopausal as defined by spontaneous amenorrhea for 
≥ 12 months; 
 
Surgically sterile or have a partner who is sterile (i.e., vasectomy in males at 
least six (6) months prior to enrollment or tubal ligation, absence of ovaries 
and/or uterus in females); 
 
Use of medically effective contraception with a failure rate of < 1% per year 
when used consistently and correctly from screening until 1 month following last 
dose. Acceptable methods include:  
‒ 
hormonal contraception including implants, injections or oral; 
‒ 
two barrier methods, e.g., condom and cervical cap (with spermicide) or 
diaphragm (with spermicide); 
‒ 
abstinence when this is the subject’s preferred and usual lifestyle. Note: 
Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-
ovulation methods) and withdrawal are not acceptable methods of 
contraception. 
Exclusion Criteria: 
a. Pregnant or breastfeeding, or intending to become pregnant or father children within 
the projected duration of the trial starting with the screening visit until 1 month following 
last dose; 
b. Positive serum pregnancy test during screening or positive urine pregnancy test prior 
to dosing; 
c. History of respiratory diseases such as asthma, chronic obstructive pulmonary disease 
or chronic bronchitis; 
d. Is currently participating in or has participated in a study with an investigational product 
with 30 days preceding Day 0; 
e. Previous receipt of an investigational vaccine product for prevention of MERS  or 
SARS; 
f. 
Prior exposure to MERS-CoV or camels (serology or antibody testing will be requested 
at the Investigator’s discretion); 
g. Participants who participated in MERS-201 Part 1 cannot participate in MERS-201 Part 
2; 

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h. Fewer than two acceptable sites available for ID injection and EP considering the 
deltoid and anterolateral quadriceps muscles. The following are unacceptable sites: 
 
Tattoos, keloids or hypertrophic scars located within 2 cm of intended 
administration site; 
 
Implantable-Cardioverter-defibrillator (ICD) or pacemaker (to prevent a life-
threatening arrhythmia) that is located ipsilateral to the deltoid injection site 
(unless deemed acceptable by a cardiologist); 
 
Any metal implants or implantable medical device within the electroporation 
site; 
i. 
Prisoner or participants who are compulsorily detained (involuntary incarceration); 
j. 
Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, 
topical skin and/or eye drop-containing corticosteroids) prior to dosing. Systemic 
corticosteroids must be discontinued at least 3 months prior to first dose;  
k. Reported active drug or alcohol or substance abuse or dependence. 
Clinical Trial Treatment: 
 
Part 1 Group A – One 0.6 mg ID injection of INO-4700 followed by EP administered 
at Day 0 and Week 4 (± 5 days) 
 
Part 1 Group B – One 1.0 mg ID injection of INO-4700 followed by EP  administered 
at Day 0 and Week 4 (± 5 days) 
 
Part 1 Group C – One 1.0 mg ID injection of INO-4700 followed by EP administered 
at Day 0 and Week 8 (± 5 days) 
 
Part 1 Group D – Two 0.5 mg ID injections (in an acceptable location on two 
different limbs) of INO-4700 followed by EP administered at Day 0 and Week 8 (± 
5 days) 
 
Part 1 Group E – Two 1.0 mg ID injections (in an acceptable location on two different 
limbs) of INO-4700 followed by EP administered at Day 0 and Week 4 (± 5 days) 
 
Part 1 Group F – One ID injection of placebo followed by EP administered at Day 0 
and Week 4 (± 5 days) 
 
Part 1 Group G – One ID injection of placebo followed by EP administered at Day 
0 and Week 8 (± 5 days) 
 
Part 1 Group H – Two ID injections (in an acceptable location on two different limbs) 
of placebo followed by EP administered at Day 0 and Week 8 (± 5 days) 
 
Part 1 Group I – Two ID injections (in an acceptable location on two different limbs) 
of placebo followed by EP administered at Day 0 and Week 4 (± 5 days) 
 
Part 2 – Dose and regimen to be determined, each ID injection(s) followed by EP 
administered at Day 0, Week 4 or Week 8, and Week 48 (for Part 2B participants 
receiving a third dose) 
 
INO-4700 or placebo will be administered intradermally in ~0.1 mL dose volume followed 
immediately by EP. 
Formulation: 
INO-4700 in sodium chloride and sodium citrate, refrigerated. Placebo [sterile saline sodium 
citrate buffer (SSC-0001)], refrigerated. 
 
 

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FIGURE 1 – STUDY DESIGN AND DOSING SCHEMA 
 
 
 

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TABLE 4 – PART 1 TRIAL SCHEDULE OF EVENTS 
Tests and assessments 
Screena 
Day 0 
Week 2 
(± 3d) 
Week 4 
(± 5d) 
Week 6 
(± 5d) 
Week 8 
(± 5d) 
Week 10 
(± 5d) 
Week 12 
(± 5d) 
Week 30b 
(± 10d) 
 
Week 48 
(± 5d) 
 
Pre 
Post 
Pre 
Post 
Pre 
Post 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Medical History 
X 
Xa 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Concomitant Medications 
X 
X 
 
X 
X 
 
X 
X 
 
X 
 
 
X 
Physical Examc 
X 
X 
 
X 
X 
 
X 
X 
 
X 
 
 
X 
Vital Signs 
X 
X 
 
X 
X 
 
X 
X 
 
X 
 
 
X 
Height and Weight 
X 
 
 
 
 
 
 
 
 
 
 
 
 
CBC with Differential 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Chemistry and Liver Functiond 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Serologye 
X 
 
 
 
 
 
 
 
 
 
 
 
 
12-lead ECG 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Urinalysis Routinef 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Pregnancy Testg 
X 
X 
 
 
Xk 
 
 
Xl 
 
 
 
 
 
INO-4700 or placebo + EPh 
 
Xi,j 
 
 
Xi,k 
 
 
Xj,l 
 
 
 
 
 
Download EP Datam 
 
 
X 
 
 
Xk 
 
 
Xl 
 
 
 
 
Adverse Eventsn 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Immunology (Whole blood)o 
X 
X 
 
X 
 
 
X 
 
 
X 
X 
 
X 
Immunology (Serum)p 
X 
X 
 
X 
 
 
X 
 
 
X 
X 
 
X 
a. 
Screening assessment occurs from -60 days to -1 day prior to Day 0. If screening occurs within 14 days prior to Day 0, then do not repeat medical history prior to dosing. 
b. 
Follow-up phone call to collect AEs 
c. 
Full physical examination at screening and Week 48 (or any other study discontinuation visit) only. Targeted physical exam at all other visits. 
d. 
Includes Na, K, Cl, HCO3, Ca, PO4, glucose, BUN, Cr, AST and ALT. 
e. 
MERS-CoV antibody (per PI discretion), HIV antibody or rapid test, HBsAg, HCV antibody. 
f. 
Dipstick for glucose, protein, and hematuria. Microscopic examination should be performed if dipstick is abnormal.  
g. 
Serum pregnancy test at screening. Urine pregnancy test at other visits.  
h. 
INO-4700 or placebo is prepared by unblinded pharmacy personnel. All doses delivered via ID injection followed by EP. 
i. 
For Study Groups A, B and F, one injection preferably over deltiod muscle at Day 0 and Week 4. For Study Groups E and I, two injections with each injection over a different deltoid or lateral 
quadriceps, preferably over the deltoid muscles, at Day 0 and Week 4. 
j. 
For Study Groups C and G, one injection preferably over deltoid muscle at Day 0 and Week 8. For Study Groups D and H, two injections with each injection over a different deltoid or lateral 
quadriceps, preferably over the deltoid muscles, at Day 0 and Week 8.  
k. 
Complete only for Study Groups A, B, E, F and I. 
l. 
Complete for Study Groups C, D, G and H. 
m. 
Following administration of INO-4700 or placebo, EP data will be downloaded from the CELLECTRATM 2000 device and provided to Inovio. 
n. 
Includes AEs from the time of consent and all injection site reactions that qualify as an AE. All AEs collected until 12 weeks from Day 0. Related AEs, AESIs and SAEs collected thereafter. 
o. 
4 x 8.5 mL (34 mL) whole blood in 10 mL Acid Citrate Dextrose (ACD, Yellow top) tubes per time point. Note: Collect a total of 68 mL whole blood prior to 1st dose (screening and prior to Day 0 
dosing). 
p. 
1 x 8 mL blood in 10 mL red top serum collection tube per time point. Note: Collect four aliquots of 1 mL each (total 4 mL) serum at each time point prior to 1st dose (Screening and prior to Day 0 
dosing).  

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TABLE 5 – PART 2 TRIAL SCHEDULE OF EVENTS (DAY 0 & WEEK 4 OPTIMAL REGIMEN) 
Tests and assessments 
Screena 
Day 0 
Week 2 
(± 3d) 
Week 4 
(± 5d) 
Week 6 
(± 5d) 
Week 8b 
(± 5d) 
Week 12 
(± 5d) 
Week 30b 
(± 10d) 
Week 48 
(± 5d) 
Week 50i 
(± 5d) 
Week 68i 
(± 10d) 
Pre Post 
Pre Post 
Pre Post 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history 
X 
Xa 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Concomitant Medications 
X 
X 
 
X 
X 
 
X 
 
 
 
X 
 
X 
X 
Physical Examc 
X 
X 
 
X 
X 
 
X 
 
 
 
X 
 
X 
X 
Vital Signs 
X 
X 
 
X 
X 
 
X 
 
 
 
X 
 
X 
X 
Height and Weight 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
CBC with differential 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
X 
X 
Chemistry and Liver Functiond 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
X 
X 
Serologye 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
12-lead ECG 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urinalysis Routinef 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
X 
X 
Pregnancy Testg 
X 
X 
 
 
X 
 
 
 
 
 
Xi 
 
 
 
INO-4700 or placebo + EPh 
X 
X 
 
 
X 
 
 
 
 
 
Xi 
 
 
 
Download EP Dataj 
 
 
X 
 
 
X 
 
 
 
 
 
Xi 
 
 
Adverse Eventsk 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Xi 
X 
X 
Immunology (Whole blood)l 
X 
X 
 
X 
 
 
X 
 
X 
 
X 
 
X 
X 
Immunology (Serum)m 
X 
X 
 
X 
 
 
X 
 
X 
 
X 
 
X 
X 
a. 
Screening assessment occurs from -60 days to -1 day prior to Day 0. If screening occurs within 14 days prior to Day 0, then do not repeat medical history prior to dosing. 
b. 
Follow-up phone call to collect AEs. 
c. 
Full physical examination at screening and Week 48 (participants receiving only two doses) or Week 68 (participants receiving three doses), as well as any other study discontinuation 
visit. Targeted physical exam at all other visits. 
d. 
Includes Na, K, Cl, HCO3, Ca, PO4, glucose, BUN, Cr, AST and ALT. 
e. 
MERS-CoV antibody (per PI discretion), HIV antibody or rapid test, HBsAg, HCV antibody. 
f. 
Dipstick for glucose, protein, and hematuria. Microscopic examination should be performed if dipstick is abnormal.  
g. 
Serum pregnancy test at screening. Urine pregnancy test prior to dosing at other visits.  
h. 
INO-4700 or placebo is prepared by unblinded pharmacy personnel. All doses delivered via ID injection followed by EP. 
i. 
Complete only for participants receiving a third dose of either INO-4700 or placebo (Part 2B). 
j. 
Following administration of INO-4700 or placebo, EP data will be downloaded from the CELLECTRATM 2000 device and provided to Inovio. 
k. 
Includes AEs from the time of consent and all injection site reactions that qualify as an AE. All AEs collected until 12 weeks from Day 0. Related AEs, AESIs and SAEs collected 
thereafter. 
l. 
4 x 8.5 mL (34 mL) whole blood in 10 mL Acid Citrate Dextrose (ACD, Yellow top) tubes per time point. Note: Collect a total of 68 mL whole blood prior to 1st dose (screening and prior 
to Day 0 dosing). 
m. 
1 x 8 mL blood in 10 mL red top serum collection tube per time point.  Note:  Collect four aliquots of 1 mL each (total 4 mL) serum at each time point prior to 1st dose (Screening and 
prior to Day 0 dosing).  
 

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TABLE 6 – PART 2 TRIAL SCHEDULE OF EVENTS (DAY 0 & WEEK 8 OPTIMAL REGIMEN) 
Tests and assessments 
Screena 
Day 0 
Week 2 
(± 3d) 
Week 4b 
(± 5d) 
Week 8 
(± 5d) 
Week 10 
(± 5d) 
Week 12 
(± 5d) 
Week 30b 
(± 10d) 
Week 48 
(± 5d) 
Week 50i 
(± 5d) 
Week 68i 
(± 10d) 
Pre Post 
Pre Post 
Pre Post 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history 
X 
Xa 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Concomitant Medications 
X 
X 
 
X 
 
X 
 
X 
 
 
X 
 
X 
X 
Physical Examc 
X 
X 
 
X 
 
X 
 
X 
 
 
X 
 
X 
X 
Vital Signs 
X 
X 
 
X 
 
X 
 
X 
 
 
X 
 
X 
X 
Height and Weight 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
CBC with differential 
X 
 
 
X 
 
 
 
X 
 
 
X 
 
X 
X 
Chemistry and Liver Functiond 
X 
 
 
X 
 
 
 
X 
 
 
X 
 
X 
X 
Serologye 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
12-lead ECG 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urinalysis Routinef 
X 
 
 
X 
 
 
 
X 
 
 
X 
 
X 
X 
Pregnancy Testg 
X 
X 
 
 
 
X 
 
 
 
 
Xi 
 
 
 
INO-4700 or placebo + EPh 
X 
X 
 
 
 
X 
 
 
 
 
Xi 
 
 
 
Download EP Dataj 
 
 
X 
 
 
 
X 
 
 
 
 
Xi 
 
 
Adverse Eventsk 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Xi 
X 
X 
Immunology (Whole blood)l 
X 
X 
 
X 
 
 
 
X 
X 
 
X 
 
X 
X 
Immunology (Serum)m 
X 
X 
 
X 
 
 
 
X 
X 
 
X 
 
X 
X 
a. 
Screening assessment occurs from -60 days to -1 day prior to Day 0. If screening occurs within 14 days prior to Day 0, then do not repeat medical history prior to dosing. 
b. 
Follow-up phone call to collect AEs. 
c. 
Full physical examination at screening and Week 48 (participants receiving only two doses) or Week 68 (participants receiving three doses), as well as any other study discontinuation 
visit. Targeted physical exam at all other visits. 
d. 
Includes Na, K, Cl, HCO3, Ca, PO4, glucose, BUN, Cr, AST and ALT. 
e. 
MERS-CoV antibody (per PI discretion), HIV antibody or rapid test, HBsAg, HCV antibody. 
f. 
Dipstick for glucose, protein, and hematuria. Microscopic examination should be performed if dipstick is abnormal.  
g. 
Serum pregnancy test at screening. Urine pregnancy test prior to dosing at other visits.  
h. 
INO-4700 or placebo is prepared by unblinded pharmacy personnel. All doses delivered via ID injection followed by EP. 
i. 
Complete only for participants receiving a third dose of either INO-4700 or placebo (Part 2B). 
j. 
Following administration of INO-4700 or placebo, EP data will be downloaded from the CELLECTRATM 2000 device and provided to Inovio. 
k. 
Includes AEs from the time of consent and all injection site reactions that qualify as an AE. All AEs collected until 12 weeks from Day 0. Related AEs, AESIs and SAEs collected 
thereafter. 
l. 
4 x 8.5 mL (34 mL) whole blood in 10 mL Acid Citrate Dextrose (ACD, Yellow top) tubes per time point. Note: Collect a total of 68 mL whole blood prior to 1st dose (screening and prior 
to Day 0 dosing). 
m. 
1 x 8 mL blood in 10 mL red top serum collection tube per time point.  Note:  Collect four aliquots of 1 mL each (total 4 mL) serum at each time point prior to 1st dose (Screening and 
prior to Day 0 dosing).  

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1.0 
INTRODUCTION 
This document is a protocol for a human research trial to be conducted according to US 
and international standards of Good Clinical Practice (GCP) (FDA Title 21 part 312, 812 
and International Conference on Harmonization (ICH) guidelines), applicable government 
regulations and Institutional research policies and procedures. 
1.1 
BACKGROUND AND SCIENTIFIC RATIONALE 
The lack of available therapy in conjunction with increasing numbers of global cases 
indicates that MERS-CoV infection remains a serious unmet medical need. Due to cross-
species infection, both human and animal outbreaks are possible. Appropriate measures 
to prevent, control and treat existing and future infections are needed. 
1.2 
BACKGROUND INFORMATION 
First reported in 2012 in a patient from Saudi Arabia presenting with pneumonia and acute 
kidney injury, Middle East Respiratory Syndrome Coronavirus (MERS-CoV) was originally 
known as coronavirus-EMS (Erasmus Medical Center) [1]. Although only more recently 
has human infection been identified, evidence suggests that MERS-CoV has existed in 
central and east Africa for decades [2]. MERS-CoV belongs to the family Coronaviridae, 
which includes four major groups: alpha, beta, gamma and delta. Although genomically 
related to the subgroup B beta-coronavirus severe acute respiratory syndrome (SARS) 
virus, MERS-CoV belongs to the subgroup C beta-coronavirus lineage. Two main 
recognized clades (clade A and B) of MERS-CoV have been identified by phylogenetic 
analysis, of which clade B can be further subdivided into five groups (groups I, II, III, IV, 
V). As a novel beta-coronavirus with high pathogenicity, significant morbidity and mortality 
is associated with infection of this subgroup, in contrast to less severe illness with other 
coronavirus infection [3]. 
Based on analyses of MERS-CoV’s evolutionary history, natural hosts include bats 
(species Neoromicia capensis and Vespertilio superans), dromedary camel (Camelus 
dromedarius) and European hedgehog (Erinaceus europaeus) [4-7]. Its high 
recombination potential and evasion of host immune responses provides coronaviruses 
the ability to infect multiple host species, thus supporting the contribution of zoonotic 
events to adaptive evolution and disease transmission. Notably, dromedary camels are 
the only documented cross-species source for human infection [8]. However, the 
mechanism by which transmission occurs from natural animal hosts to human is still poorly 
characterized [9]. 
Those in a healthcare setting or who have come into contact with camels constitute the 
majority of known exposure routes and potential source of transmission [10]. Indeed, 
nosocomial transmission due to inadequate infection control has been established as a 
major driver of MERS-CoV infections in humans [11, 12], and contributed to the 2014 
outbreak in Saudi Arabia and 2015 outbreak in South Korea. Primary cases tend to be 
middle-aged males and those with occupational exposure to animal hosts, while 
secondary cases include younger men and women and those who’ve come into contact 
with confirmed patients. 
1.2.1 CLINICAL PRESENTATION AND IMMUNE RESPONSE 
The incubation period for MERS-CoV is about 5-7 days and can be up to 12 days. MERS-
CoV infection causes lower respiratory tract disease due to the highly susceptible nature 
of respiratory epithelial cells [13]. As such, greater viral loads are detected in the lower 
respiratory tract compared to the upper tract. Renal, intestinal and liver cells and 

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histiocytes can also be affected. Most common symptoms include fever, cough, shortness 
of breath and pneumonia, but myalgia, diarrhea, vomiting, chills and malaise have also 
been observed [10, 14]. Severe infection has been associated with acute kidney damage 
and respiratory distress requiring intensive care unit management within 2 days of hospital 
admission and can progress to multiorgan system failure [15]. Symptomatic patients carry 
MERS-CoV in tracheal aspirates, sputum and bronchoalveolar lavage fluid, and due to 
continuous viral shedding up to six weeks, patients may be able to transmit virus even 
when asymptomatic [16]. Poorer disease outcome and higher mortality may occur in older 
or immunocompromised patients and those with comorbidities, such as diabetes, cancer, 
and cardiac and chronic pulmonary disease [17].  
Multiple studies suggest that host immune function and kinetics are important factors in 
determining disease course. Although higher antibody titers in correlation with greater viral 
load and delayed development of neutralizing antibodies were associated with poorer 
prognosis, the protective effect of these antibodies during infection is not clear [18, 19]. 
Additionally, both duration and magnitude of antibody response is indicative of disease 
severity [20]. From a cellular immunity perspective, MERS-CoV may downregulate 
expression of interferon-stimulated genes and delay induction of proinflammatory 
cytokines. Cytotoxic T cells are implicated in host defense and recovery as one study 
reported CD8+ T cell responses in survivors despite the lack of an antibody response [18]. 
1.2.2 CURRENT TREATMENT AND UNMET NEED 
Current treatment focuses on symptomatic supportive care. Ribavirin and IFN-α2b 
administration have been shown to decrease viral replication in vitro, improve outcomes 
in animals and increase short-term survival in a retrospective human study [21, 22]. 
Ribavirin and IFN-α2b in combination with lopinavir is currently being tested in an 
interventional Phase 2 clinical trial (clinicaltrials.gov NCT02845843). 
Other targets in development include viral and host proteases and viral entry inhibitors, 
such as inhibition of dipeptidyl-peptidase 4 (DPP4 or CD26) on the host cell. DPP4 acts 
as the main route of entry utilized by the virus’ spike (S) protein, which is the primary target 
for neutralizing antibodies. Specifically, two monoclonal antibodies (REGN3051 and 
REGN3048) are able to bind the receptor binding domain (RBD) region within the S protein 
with high affinity and neutralize MERS-CoV in vitro [23]. In mouse models, these 
antibodies act as inhibitors against the DPP4 and S protein interaction and have shown 
effectiveness in restricting MERS-CoV replication and infection [23, 24]. Additional 
monoclonal antibodies, all targeting RBD, are being developed by several groups [25]. 
Importantly, vaccines have been prioritized as a promising alternative. Currently, there are 
no approved prophylactic nor therapeutic vaccines available for the prevention and 
treatment of MERS-CoV infection. Vaccine development for MERS-CoV may be 
challenging due to the sporadic nature of infection and lack of suitable animal models for 
challenge studies. Additionally, determinants of protection and immunity are not clearly 
defined. Development of both viral vector-based and RBD-based formats are ongoing. 
Replication deficient modified vaccinia Ankara (MVA) expressing full-length MERS-CoV 
spike protein and adenovirus vectors have demonstrated humoral and cellular immune 
responses, but adverse inflammation and safety remain a concern [26]. A live-attenuated 
MERS-CoV vaccine also exists but would require higher biosafety precautions for testing 
and would not be feasible for the target population more prone to severe MERS-CoV 
disease [27]. RBD-based vaccines are proposed to be more effective and safer than viral 
vector-based vaccines. Intranasal RBD-based immunization in animals elicits strong 
mucosal IgA responses as well as specific cell-mediated responses that may contribute 
to protection [28, 29]. Combination with adjuvants, such as aluminum or oil-based MF59, 

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has potential to increase effectiveness. However, evaluation of vaccine candidates in 
humans must be performed to better inform efficacy, and a vaccination platform that 
induces both humoral and cellular immune response could be rationalized. 
Multiple vaccine platforms are in various preclinical testing stages [25], with a few vaccine 
candidates advancing into Phase 1 clinical testing. GLS-5300 (GeneOne Life Science, 
Inc.), which is comprised of an identical DNA plasmid as INO-4700, is a DNA-based 
vaccine targeting MERS-CoV S protein and has been evaluated in a completed Phase 1 
intramuscular dose-ranging study in healthy adults (clinicaltrials.gov NCT02670187) [30], 
described further in Section 1.3.1. A second, Phase 1/2a study of GLS-5300 is ongoing to 
evaluate the safety and immunogenicity of intradermal administration (clinicaltrials.gov 
NCT03721718), described further in Section 1.3.1. Preclinical studies of GLS-5300 in 
mice, camels and non-human primates (NHPs) have demonstrated induction of 
neutralizing antibodies and antigen-specific cellular immune responses. Of note, 
vaccination in NHPs was able to protect from MERS-CoV challenge as immunized animals 
lacked respiratory distress and interstitial infiltrates, had normal lung histology and cleared 
viral loads [31]. 
1.2.3 EMERGING HEALTH THREAT 
Since 2012, the World Health Organization (WHO) has received over 2,400 laboratory-
confirmed reports of individual cases and clusters of infection, including over 800 fatalities, 
across 27 countries (Saudi Arabia accounting for 80% of human cases) [32]. The latest 
WHO-reported crude fatality rate is 35.5% [33]. Although the majority of research has 
focused on symptomatic patients, more than 62% of these individuals may remain 
unidentified or undetected or display only mild symptoms [34], thus the number of 
confirmed cases may be greatly under-reported. Not only is continued development of 
enhanced detection and active surveillance programs warranted, but also more effective 
therapeutic options are required to manage existing infections and limit spread of disease. 
In support of continued advancements to address this serious global health concern, the 
Coalition for Epidemic Preparedness Innovations (CEPI) has assigned priority disease 
designation to developing a MERS-CoV vaccine [35], and the WHO has initiated a 
blueprint for preparatory and responses efforts [36]. 
1.3 
RATIONALE 
No investigational interventions have clearly and consistently demonstrated clinical benefit 
in MERS-CoV-infected patients, thus highlighting the continued unmet need for effective 
therapeutic and preventive solutions. INO-4700 is being evaluated for both routine 
prophylaxis and use during an outbreak situation. Since the RBD domain within the 
MERS-CoV S protein is highly mutable, INO-4700 has been designed to encode 
consensus sequences of the full length S protein covering multiple epitopes in order to 
induce broad cross-reactive immune responses. The INO-4700 plasmid, which is identical 
to GLS-5300, and the plasmid DNA backbone has been tested in previous clinical trials 
[30, 37-40]. Previous experience with plasmids similar to INO-4700 has demonstrated 
tolerability and both clinically relevant and immunogenic responses. 
1.3.1 DOSE AND REGIMEN RATIONALE 
INO-4700 is identical to the previously evaluated GLS-5300, except that it is formulated at 
a higher concentration. In a completed Phase 1 clinical trial, intramuscular (IM) dose-
ranging administration of GLS-5300 delivered via EP in healthy adults was well-tolerated 
and induced seroconversion and T cell responses [30]. This study evaluated three different 
dose groups (0.67 mg, 2 mg, and 6 mg) administered IM in a three-immunization regimen 

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at Weeks 0, 4 and 12 in 75 healthy adult participants. Overall, transient local injection site 
discomfort and reactions were most commonly reported, consistent with previously 
published clinical trial reports of Inovio’s DNA delivered via EP platform. The most 
common solicited systemic adverse event was headache, followed by malaise and 
myalgia, most of which were mild. Laboratory abnormalities were uncommon, and no 
grade 3 or higher laboratory abnormalities were deemed related to the vaccine. No 
vaccine-related serious adverse events were reported. The vaccine was immunogenic in 
all dosing groups with remarkably similar antibody and neutralization titers between all 
three doses. These levels were comparable to those observed in convalescent patients 
who have recovered from MERS-CoV infection. Furthermore, the vaccine generated long-
lasting T cell responses that maintained average levels higher than convalescent patients 
for at least 60 weeks. Flow cytometry analysis and intracellular cytokine staining detected 
increases in CD8+ T cells secreting IFNγ and TNFα and CD4+ T cells secreting TNFα. In 
summary, the data from this first Phase 1 trial supports the strong immunogenicity of the 
vaccine and ability to induce durable immune responses for at least 1 year.   
In an ongoing Phase 1/2a dose-ranging clinical trial, the safety, tolerability and 
immunogenicity of GLS-5300 delivered intradermally (ID) followed by EP in 60 healthy 
volunteers is being evaluated. Dose levels include 0.3 mg administered in a three-
immunization regimen at Week 0, 4 and 12, 0.6 mg administered in a three-immunization 
regimen at Week 0, 4 and 12, and 0.6 mg administered in a two-immunization regimen at 
Week 0 and 8. As of June 2019, there have been no reports of treatment-associated 
serious adverse events and the majority of adverse events reported have been grade 1 or 
grade 2 in severity. Adverse event data standardization is in progress, but the most 
commonly reported adverse events are similar to that reported in the completed Phase 1 
trial.  
An interim analysis has showed that ID delivery of GLS-5300 induced a robust binding 
antibody and IFNγ cellular immune response in humans. A dose response was observed, 
such that the 0.6 mg dose induced significantly higher humoral and cellular immune 
responses. The 0.6 mg dose induced up to a 76% seroconversion rate following a single 
immunization, 88% seroconversion following the second immunization, and 100% 
seroconversion following the third. The 0.6 mg dose also induced robust cellular immune 
responses, with 56% responders after the second immunization and 78% responders after 
the third. The two-immunization regimen (Week 0 and 8 dosing) appeared to induce 
significantly higher antibody titers than the three-immunization regimen (Week 0, 4 12) as 
early as 2 weeks post second immunization, without affecting the cellular immune 
response. The overall response rate for the 0.6 mg dose, three-immunization regimen 
reached 92% after two immunizations and increased to 100% following the third 
immunization. The 0.6 mg dose, two-immunization regimen reached an overall response 
rate of 96% after only two immunizations.  
Results from the complete Phase 1 clinical trial as well as interim safety and 
immunogenicity results from the ongoing Phase 1/2a clinical trial support continued 
evaluation of this plasmid in a demographically relevant population.  
Intradermal delivery has been shown to be a more tolerable route of administration that 
induces superior humoral immune responses for previously evaluated DNA vaccines 
targeting viruses such as Ebola, Zika and HIV [39-41]. 
As such, Part I of the current clinical trial represents the dose-finding phase of the study 
to supplement previously amassed safety and immunogenicity data. Participants in Part 1 
will receive dosing on Day 0 and Week 4 or Week 8, with a starting dose of INO-4700 of 

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0.6 mg, which demonstrated robust immunogenicity in the Phase 1/2a trial of GLS-5300 
delivered ID followed by EP.  
Furthermore, a long-term kinetic study of serologic responses from patients who 
recovered during the 2015 South Korea outbreak reports more rapid waning of antibody 
response during the first 6 months of disease onset that stabilizes between 6 months to 1 
year [42]. Similarly, a study of survivors from the 2014 Saudi Arabia outbreak reports fewer 
patients with positive antibody response at 10 months following disease onset compared 
to 3 months [43]. As this data may indicate variable response over time, participants in 
Part 2 will receive dosing on Day 0 and Week 4 or 8 and a booster dose at Week 48 (only 
for the first 225 participants). Part 2 will thus confirm the optimal dose identified in Part 1 
and will serve to also evaluate the impact of a booster/third dose. 
Based on the at-risk population, active immunization should demonstrate ability to drive 
clinically relevant immune responses within 4-6 weeks of administration with long-term 
protection. Additionally, the WHO target product profile for a MERS-CoV vaccine suggests 
dosing regimens of no more than 3 doses in prophylactic settings and no more than 2 
doses in reactive settings, with short intervals between doses [44].  
1.3.2 DNA VACCINES 
Since the 1990s, a novel approach to vaccination against a broad array of target antigens 
and diseases has been in development. This involves the direct introduction of plasmid 
deoxyribonucleic acid (DNA) containing the gene encoding the immunogen against which 
an immune response is sought into appropriate host tissues and the in situ production of 
the target immunogen(s). This approach offers a combination of potential advantages, 
including the stimulation of both B and T-cell responses, stability of the vaccine across a 
broad temperature range, absence of infectivity of the immunogen itself, the speed with 
which the vaccine can be constructed (for example in the face of an epidemic or pandemic 
as it is the case here with SARS-CoV-2), and the relative ease and generic nature of large-
scale manufacture. Many scientific publications have addressed the potential of DNA 
vaccination [45-54]. Immune responses in animal models have been obtained using genes 
from a variety of infectious agents including influenza viruses, hepatitis B virus, human 
immunodeficiency virus, human papillomaviruses, Marburg virus, Middle East Respiratory 
Syndrome (MERS) coronavirus, rabies virus, Severe Acute Respiratory Syndrome 
(SARS) coronavirus, West Nile virus (WNV), Zika virus, and other infectious agents as 
plasmodium, mycoplasma, and many more [53, 55] In many cases, protection from 
disease in animal models has also been demonstrated.  
DNA vaccines are able to generate both CD4+ and CD8+ T cell responses. The ability to 
generate MHC-Class I restricted CD8+ T cells (cytolytic T lymphocytes), which generally 
are not made following administration of inactivated viruses, proteins or peptides, may be 
important for key responses against certain pathogens, as well as enabling cross-strain 
specific responses when many antibody responses are strain-specific. Because the 
encoded protein is synthesized in vivo by the host following administration, DNA vaccines 
can encode membrane-bound proteins instead of solely the soluble versions [56]. This 
can be important because key neutralizing epitopes are located in regions that would be 
excluded, or not formed in a monomeric truncated soluble version. Unlike certain other 
vectors (such as heterologous viral vectors), DNA vaccines do not stimulate adaptive 
immune responses against themselves, although the DNA itself does stimulate certain 
innate immune responses [57]. In other words, they do not generate anti-vector immunity 
that could stunt antigen-specific responses following multiple exposures. 
1.3.3 USE OF ELECTROPORATION WITH DNA VACCINES 

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Electroporation (EP) enhances gene expression of plasmid DNA delivered by the 
intramuscular (IM) or intradermal (ID) routes of administration (Figure 2). Following IM or 
ID delivery of a DNA vaccine or therapeutic product, EP facilitates entry of the DNA into 
the target site: muscle or dermal cells. Following cellular uptake, there is efficient 
production of the proteins encoded by the DNA expression plasmid system. The different 
EP devices, each with varying electrical parameters and protocols, have been reviewed 
[58]. EP has been extensively tested in animal species such as dogs, pigs, cattle, and 
NHPs to deliver therapeutic genes that encode for a variety of hormones, cytokines, 
enzymes or antigens [58] for the activation of both cellular and humoral responses [59, 
60]. Importantly, immune responses generated by DNA vaccines delivered with EP are far 
superior to responses to the same vaccines delivered without EP [60]. IM and ID delivery 
of DNA vaccines with EP has been studied extensively, and optimum conditions for 
plasmid uptake and expression have been described for therapeutic indications, vaccines 
and tumor animal model systems [61, 62].  
The Inovio Pharmaceuticals constant current EP device [58] referred to as the 
CELLECTRA™ 2000 for ID administration (3P-ID) device will be used in this clinical trial. 
The ID route of delivery has been selected for INO-4700 based on recent findings from 
multiple DNA vaccine development programs where ID delivery has driven equivalent if 
not superior humoral and cellular responses while improving tolerability (clinicaltrials.gov 
NCT02464670, clinicaltrials.gov NCT02431767) [40]. 
Figure 2: How Electroporation Works in the Body 
 
1.4 
POTENTIAL BENEFITS AND RISKS 
As of September 30 2019, a total of 75 participants have been dosed with INO-4700 IM 
and 60 participants with INO-4700 ID. In studies of INO-4700 administered IM followed by 
EP using CELLECTRA™ 2000 devices in healthy volunteers the most frequently reported 
AE has been injection site pain (94.7%), of which all were Grade 2 or less. In the ongoing 

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study of INO-4700 administered ID followed by EP using CELLECTRA™ 2000 devices in 
healthy volunteers, the most frequently reported AE has been erythema (63.3%), of which 
all were Grade 1  (taken from unvalidated data as a preliminary analysis).  
No specific AE has been identified as a risk. There may be potential benefit for prevention 
of MERS infection in affected areas, but efficacy is still unknown. Data gathered in this 
trial will be useful for future development of this vaccine for MERS-CoV. 
Additional details regarding the benefits and risks for participants participating in this 
clinical trial may be found in the Investigator’s Brochure (IB). 
2.0 
OBJECTIVES AND PURPOSE 
The overall purpose of this clinical trial is to evaluate INO-4700 in a demographically 
relevant population with the eventual goal of preparation for both routine prophylaxis and 
use during an outbreak situation. 
2.1 
HYPOTHESIS 
A selected optimal dose of INO-4700 delivered ID followed by EP using CELLECTRATM 
2000 in healthy volunteers will be well tolerated, exhibit an acceptable safety profile and 
result in generation of immune responses to MERS-CoV. 
3.0 
CLINICAL TRIAL DESIGN AND ENDPOINTS 
This is a Phase 2a, randomized, blinded, placebo-controlled, multi-center trial to evaluate 
the safety, tolerability and immunological profile of INO-4700 administered by ID injection 
followed by EP using the CELLECTRATM 2000 device in healthy adult volunteers. The 
primary objectives of this trial are to evaluate the tolerability, safety and immunogenicity 
of INO-4700 administered by ID injection followed by EP in healthy adult volunteers 
according to the regimens outlined in Table 1, Table 2, Table 3 and Figure 1.  
Approximately 542 healthy volunteers will be evaluated across two (2) parts of this study, 
Part 1 and Part 2. INO-4700 or placebo (SSC-0001) will be administered ID in ~0.1 mL 
dose volume followed immediately by EP. 
Part 1 – Dose Finding 
In Part 1, approximately 192 participants ages 18-50 years will be assessed through five 
(5) dose levels and regimens. These five (5) dose levels and regimens will be evaluated 
across nine (9) groups designated Study Groups A, B, C, D, E, F, G, H and I. Study Groups 
A, B, C, D and E will receive INO-4700 and enroll approximately 32 participants per group. 
Study Groups F, G, H and I will receive placebo and enroll approximately 8 participants 
per group. 
Participants will be randomized to receive either INO-4700 or placebo according to the 
dosing schedule described in Table 1. All participants and all clinical site staff will remain 
blinded to the subject treatment allocation (i.e., INO-4700 or placebo) within each Study 
Group, with the exception of the site’s pharmacy personnel.  
Enrollment into all Study Groups will proceed in parallel. Once the first four (4) participants 
in Active Study Groups and the first two (2) participants in Placebo Study Groups have 
Week 2 clinical laboratory and adverse event data available, the results will be reviewed 
by the DSMB (Figure 1). Enrollment will not be paused during this DSMB review, and 
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Upon completion of the Week 10 visit and availability of immunological data, Part 1 will be 
unblinded in order to allow for one regimen to be selected for advancement into Part 2. 
The Study Group with an optimal immune response, an acceptable safety profile and 
tolerant dosing regimen by Week 10 will be selected for Part 2. The Sponsor will remain 
blinded through Part 1 of the study until initiation of the Week 10 data review. 
All Part 1 participants will be followed for 48 weeks from the Day 0 dosing [i.e., Week 48 
will be the planned End of Study (EOS) visit]. 
Part 2 – Expansion   
In Part 2, approximately 350 participants will be evaluated across one (1) dose level and 
regimen as outlined in Table 2 and Table 3. The dose level and regimen will be identified 
based on the optimal dose selection from Part 1. Enrollment into Part 2 may begin 
following completion of the Week 10 optimal dose and regimen selection in Part 1 (i.e., 
prior to Week 48 completion in Part 1). 
In Part 2A, participants will be randomized to receive the optimal dose of active (INO-
4700) selected in Part 1 of this study or placebo (SSC-0001) (Figure 1). Approximately 
300 participants will receive INO-4700 and 50 participants will receive placebo. 
In Part 2B, the first 200 participants randomized to the Part 2A Active Study Group will 
receive a third dose of either INO-4700 or placebo at Week 48. Specifically, Study Group 
“Active – Booster” will receive INO-4700 at the first (Day 0), second (Week 4 or 8) and 
third (booster at Week 48) doses. Study Group “Active – Placebo” will receive INO-4700 
at the first (Day 0) and second (Week 4 or 8) doses, and placebo at the third (Week 48) 
dose. Similarly, in Part 2B, the first 25 participants randomized to the Part 2A Placebo 
Study Group will receive a third dose of placebo at Week 48. Collectively, these first 225 
participants will be followed for 68 weeks from the Day 0 dosing [i.e., Week 68 will be the 
planned End of Study (EOS) visit]. All remaining 125 participants in Part 2A (i.e., those 
receiving only 2 doses) will be followed for 48 weeks from the Day 0 dosing [i.e., Week 48 
will be the planned End of Study (EOS) visit]. 
All participants and all clinical site staff will remain blinded to the subject treatment 
allocation (i.e., INO-4700 or placebo), with the exception of the site’s pharmacy personnel. 
Enrollment into Active and Placebo Study Groups will proceed in parallel. No enrollment 
pauses are planned. 
Upon completion of the Week 12 visit and availability of immunological data, group-level 
(INO-4700 or placebo) unblinded summaries of immunogenicity and safety will be 
produced. This Week 12 analysis will serve to inform product development goals. The 
Sponsor will continue to remain blinded to subject-level treatment allocation (i.e., INO-
4700 or placebo) for the remainder of the trial. 
DSMB for Parts 1 and 2 
The DSMB will remain unblinded throughout the duration of the study.  
In Part 1, the DSMB will review clinical laboratory and adverse event data for the first six 
(6) participants, 4 active and 2 placebos, in each Active and Placebo Study Group, 
respectively, once the Week 2 safety data are complete. The DSMB will again convene to 
review all available safety data for all Study Groups once approximately 50% of planned 
participants are enrolled (i.e., approximately 96 participants), and once enrollment is 
complete.  
Subsequently, the DSMB will convene every three (3) calendar months thereafter until 
study completion. Enrollment pauses are not planned during any DSMB review in Part 1 
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Should the criteria for any stopping rule be met, at any time, the DSMB will be notified 
immediately, and the study may be paused or stopped if the DSMB considers the safety 
data unsatisfactory. In this case, further enrollment and administration of INO-4700 or 
placebo to participants will be paused for further evaluation. The Sponsor will perform an 
investigation and consult the DSMB and other experts, if needed, to determine whether to 
resume randomization and/or dosing of the remainder of the participants to the study or 
Study Group(s). 
3.1 
PRIMARY OBJECTIVES 
 
Evaluate the tolerability and safety of INO-4700 administered by ID injection followed 
by EP in healthy adult volunteers 
 
Evaluate the cellular (T cell) and humoral immune response to INO-4700 
administered by ID injection followed by EP for identification and confirmation of an 
optimal dose and regimen 
 
Evaluate selected optimal dose for safety and immunogenicity 
3.2 
PRIMARY ENDPOINTS 
Safety Endpoints: 
 
Incidence of adverse events by system organ class (SOC), preferred term (PT), 
severity and relationship to investigational product  
 
Administration (i.e., injection) site reactions (described by frequency and severity)  
 
Incidence of adverse events of special interest 
Immunogenicity Endpoints: 
 
Overall Immune response 
o MERS-CoV antigen specific antibodies  
o Antigen-specific cytokine-producing T cell responses  
3.3 
EXPLORATORY OBJECTIVE  
 
Evaluate the expanded immunological profile by assessing both T and B cell immune 
responses 
 
Evaluate the cellular (T cell) and humoral immune response to INO-4700 
administered by ID injection followed by EP for impact of boosting with a third dose 
3.4 
EXPLORATORY ENDPOINT  
 
Expanded immunological profile which may include (but not limited to) additional 
assessment of T and B cell numbers and T and B cell molecular changes by 
measuring immunologic proteins and mRNA levels of genes of interest at all weeks 
as determined by sample availability 
3.5 
SAFETY ASSESSMENT 
For Part 1, adverse events will be collected at every visit and safety samples will be 
drawn at Screening, Week 2, Week 6, Week 10 and Week 48. For Part 2, adverse events 
will be collected at every visit and safety samples will be drawn at Screening, Week 2, 
Week 6 (if optimal regimen includes dosing at Week 4), Week 10 (if optimal regimen 
includes dosing at Week 8), Week 48, Week 50 (for participants receiving three doses) 
and Week 68 (for participants receiving three doses). Refer to the Schedule of Events 
Table 4, Table 5 and Table 6 for additional details. 
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from the time of consent to 12 weeks from Day 0. Only related adverse events, AESIs, 
and serious adverse events will be collected thereafter. 
Additionally, for both Parts 1 and 2, a pregnancy test will be performed at screening and 
prior to each dose. 
3.6 
IMMUNOGENICITY ASSESSMENT 
For Part 1, immunology blood samples will be collected at Screening, Day 0, Week 2, 
Week 6, Week 10, Week 12 and Week 48. For Part 2, immunology blood samples will be 
collected at Screening, Day 0, Week 2, Week 6 (if optimal regimen includes dosing at 
Week 4), Week 10 (if optimal regimen includes dosing at Week 8), Week 12, Week 48, 
Week 50 (for Part 2B participants receiving three doses) and Week 68 (for Part 2B 
participants receiving three doses). Refer to the Schedule of Events Table 4, Table 5 and 
Table 6 for additional details. Determination of analysis of collected samples for 
immunological endpoints will be determined on an ongoing basis throughout the study. 
4.0 
CLINICAL TRIAL POPULATION 
4.1 
INCLUSION CRITERIA 
a. Able to provide informed consent and have signed Informed Consent Form (ICF) prior 
to screening procedures; 
b. For Part 1, adults age 18 and 50 years, inclusive. For Part 2, adults at least 18 years 
of age; 
c. Judged to be healthy by the Investigator on the basis of medical history, physical 
examination and vital signs performed at Screening. Note: Participants taking daily 
prescription or non-prescription medications for management of acceptable chronic 
medical conditions must be on a stable dose, as defined by non-change in dose for 
the 3 months prior to the first dose of study medication and no planned changes 
during the active dosing period of the study; 
d. Able and willing to comply with all study procedures; 
e. Screening laboratory results within normal limits for testing laboratory or deemed not 
clinically significant by the Investigator; 
f. 
Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C 
antibody and Human Immunodeficiency Virus (HIV) antibody or rapid test at 
screening; 
g. Screening ECG deemed by the Investigator as having no clinically significant findings 
(e.g. Wolff-Parkinson-White syndrome); 
h. Must meet one of the following criteria with respect to reproductive capacity: 
 
Women who are post-menopausal as defined by spontaneous amenorrhea 
for ≥ 12 months; 
 
Surgically sterile or have a partner who is sterile (i.e., vasectomy in males at 
least six (6) months prior to enrollment or tubal ligation, absence of ovaries 
and/or uterus in females); 
 
Use of medically effective contraception with a failure rate of < 1% per year 
when used consistently and correctly from screening until 1 month following 
last dose. Acceptable methods include:  
‒ 
hormonal contraception including implants, injections or oral; 
‒ 
two barrier methods, e.g., condom and cervical cap (with spermicide) or 
diaphragm (with spermicide); 
‒ 
abstinence when this is the subject’s preferred and usual lifestyle. Note: 
Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-

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ovulation methods) and withdrawal are not acceptable methods of 
contraception. 
4.2 
EXCLUSION CRITERIA 
a. Pregnant or breastfeeding, or intending to become pregnant or father children within 
the projected duration of the trial starting with the screening visit until 1 month 
following last dose; 
b. Positive serum pregnancy test during screening or positive urine pregnancy test prior 
to dosing; 
c. History of respiratory diseases such as asthma, chronic obstructive pulmonary 
disease or chronic bronchitis; 
d. Is currently participating in or has participated in a study with an investigational 
product with 30 days preceding Day 0; 
e. Previous receipt of an investigational vaccine product for prevention of MERS  or 
SARS; 
f. 
Prior exposure to MERS-CoV or camels (serology or antibody testing will be 
requested at the Investigator’s discretion); 
g. Participants who participated in MERS-201 Part 1 cannot participate in MERS-201 
Part 2; 
h. Fewer than two acceptable sites available for ID injection and EP considering the 
deltoid and anterolateral quadriceps muscles. The following are unacceptable sites: 
 
Tattoos, keloids or hypertrophic scars located within 2 cm of intended 
administration site; 
 
Implantable-Cardioverter-defibrillator (ICD) or pacemaker (to prevent a life-
threatening arrhythmia) that is located ipsilateral to the deltoid injection site 
(unless deemed acceptable by a cardiologist); 
 
Any metal implants or implantable medical device within the electroporation 
site; 
i. 
Prisoner or participants who are compulsorily detained (involuntary incarceration); 
j. 
Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, 
topical skin and/or eye drop-containing corticosteroids) prior to dosing. Systemic 
corticosteroids must be discontinued at least 3 months prior to first dose;  
k. Reported active drug or alcohol or substance abuse or dependence. 
4.3 
DISCONTINUATION/WITHDRAWAL OF CLINICAL TRIAL PARTICIPANTS 
Participants may withdraw consent at any time for any reason or be dropped from the trial 
at the discretion of the Investigator should any untoward effect occur. In addition, the 
Investigator or the Sponsor has the right to withdraw a subject from the trial at any time. 
The Investigator must notify the Sponsor immediately when a subject has been 
discontinued/withdrawn due to an Adverse Event (AE). If a subject discontinues from the 
trial or is withdrawn from the trial prior to trial completion, all applicable activities scheduled 
for the final trial visit (i.e., Part 1 Week 48 EOS or Part 2 Week 48 or 68 EOS) should be 
performed at the time of discontinuation. Any AEs and/or Serious Adverse Events (SAEs) 
present at the time of discontinuation/withdrawal should be followed in accordance with 
the safety requirements outlined in Section 7.9: Safety Data Reporting Period, Method of 
Collection and Submission. 
Unless a subject refuses to continue participation, all follow-up visits and procedures 
should be completed as indicated in the Schedule of Events (Tables 3, 4 and 5) following 
the last dose whether or not the subject has completed all doses. 
 

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Reasons for withdrawal from the trial may include but are not limited to the following: 
 
Subject withdrawal of consent at any time 
 
Any medical condition that the Investigator or Sponsor determines may jeopardize 
the subject’s safety if he or she continues in the trial 
 
Investigator, DSMB or Sponsor determines it is in the best interest of the subject 
 
Subject non-compliance 
 
Every effort should be made to obtain information on participants who withdraw from the 
trial. The primary reason for withdrawal from the trial should be documented on the 
appropriate eCRF. However, participants will not be followed for any reason after consent 
has been withdrawn. Data and/or samples collected prior to withdrawal of consent will be 
analyzed.  
 
Subject dosing may be discontinued if they experience any of the following: 
 
Adverse Event (Adverse Reaction) 
o The Investigator or trial coordinator must notify the Sponsor immediately 
when a subject has been discontinued/withdrawn due to an Adverse Event 
(AE). 
 
Any medical condition that may jeopardize the subject’s safety if he or she 
continues on trial  
 
Pregnancy 
5.0 
CLINICAL TRIAL TREATMENT 
5.1 
INVESTIGATIONAL PRODUCTS (IPS) AND STUDY DEVICE 
5.1.1 INO-4700 AND SSC-0001 
Investigational product is defined as a pharmaceutical form of an active ingredient or 
placebo being tested or used as a reference in the study, whether blinded or unblinded. 
INO-4700 is the active investigational product to be used in this study. The INO-4700 drug 
product contains 10 mg/mL pGX9101 in 1X SSC buffer (150 mM sodium chloride and 15 
mM sodium citrate). A volume of 0.4 mL will be filled into 2-mL glass vials that are fitted 
with rubber stoppers and sealed aluminum caps. INO-4700 must be placed in 2–8°C 
storage immediately upon arrival and requires preparation prior to administration, which 
is outlined in the pharmacy manual. 
pGX9101 is a DNA plasmid expressing a synthetic consensus (SynCon®) Middle East 
Respiratory Syndrome Human Coronavirus Spike protein (MERS-CoV Spike), driven by 
a human CMV promoter (hCMV promoter), and with the bovine growth hormone 3’ end 
poly-adenylation signal (bGH polyA). The pGX0001 backbone includes the kanamycin 
resistance gene (KanR) and plasmid origin of replication (pUC ori). 
Sterile saline sodium citrate (SSC) buffer (SSC-0001), which contains sterile 150 mM 
sodium chloride and 15 mM sodium citrate in 10-mL glass vials, stoppered, and sealed 
with aluminum caps, will be used as the placebo at the clinical site. 
5.1.2 CELLECTRATM 2000 
The CELLECTRATM 2000 is a portable, battery-powered medical device designed to 
generate a minimally-controlled, electric field which temporarily and reversibly increases 
cellular membrane permeability without damaging the tissue. During the period of 

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increased permeability an indicated injected plasmid DNA formulation can be introduced 
into the cells. 
The CELLECTRATM 2000 device is indicated to enhance the uptake and expression of 
DNA plasmid-based biologics in order to enhance vaccine efficacy. The DNA plasmid is 
delivered separately via needle and syringe injection immediately prior to the 
electroporation. The electroporation is accomplished through a sterile, disposable needle 
Array attached to an Applicator delivering current controlled electrical pulses as follows: 
 
An EP treatment consists of four pulses. 
 
An Array of three stainless steel electrode needles is used to deliver the electrical 
pulses into the tissue. 
 
Voltage levels are limited to 200 volts (V) for patient safety.  
 
The specified current is constantly maintained through voltage modulation using 
an analog feedback loop. Measurements of voltage and current are processed for 
error reporting and collected for data logging. 
The CELLECTRATM 2000 device for ID administration is comprised of three components: 
(1) A battery-powered Pulse Generator, (2) an ID Applicator that is connected to the pulse 
generator, and (3) a three-point sterile disposable ID Array of stainless steel needles. 
5.2 
TREATMENT REGIMENS 
 
Part 1 Group A – One 0.6 mg ID injection of INO-4700 followed by EP administered at 
Day 0 and Week 4 (± 5 days) 
 
Part 1 Group B – One 1.0 mg ID injection of INO-4700 followed by EP  administered 
at Day 0 and Week 4 (± 5 days) 
 
Part 1 Group C – One 1.0 mg ID injection of INO-4700 followed by EP administered at 
Day 0 and Week 8 (± 5 days) 
 
Part 1 Group D – Two 0.5 mg ID injections (in an acceptable location on two different 
limbs) of INO-4700 followed by EP administered at Day 0 and Week 8 (± 5 days) 
 
Part 1 Group E – Two 1.0 mg ID injections (in an acceptable location on two different 
limbs) of INO-4700 followed by EP administered at Day 0 and Week 4 (± 5 days) 
 
Part 1 Group F – One ID injection of placebo followed by EP administered at Day 0 
and Week 4 (± 5 days) 
 
Part 1 Group G – One ID injection of placebo followed by EP administered at Day 0 
and Week 8 (± 5 days) 
 
Part 1 Group H – Two ID injections (in an acceptable location on two different limbs) 
of placebo followed by EP administered at Day 0 and Week 8 (± 5 days) 
 
Part 1 Group I – Two ID injections (in an acceptable location on two different limbs) of 
placebo followed by EP administered at Day 0 and Week 4 (± 5 days) 
 
Part 2 – Dose and regimen to be determined, each ID injection(s) followed by EP 
administered at Day 0, Week 4 or Week 8, and Week 48 (for Part 2B participants 
receiving a third dose) 
INO-4700 or placebo will be administered intradermally in ~0.1 mL dose volume followed 
immediately by EP. 
5.2.1 BLINDING 
This trial is randomized across Study Groups, is blinded to the Investigator and subject, 
and is placebo-controlled with blinding throughout the duration of the trial as described in 
Section 3: Clinical Trial Design and Endpoints. There is no difference in appearance 

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between INO-4700 and SSC-0001; however, they are packaged in different sized vials. 
To maintain the blind, vials will only be handled by designated unblinded personnel (site 
pharmacist) at the site. The Sponsor will also be blinded as described in Section 3: Clinical 
Trial Design and Endpoints. 
The PI may request to unblind a subject’s dose assignment in case of an emergency or 
serious medical condition when knowledge of the study product or dose is essential for 
proper clinical management of the subject, as judged by the PI. It is preferred, but not 
required, that the PI first contact the Medical Monitor (MM) to discuss options before 
unblinding the subject’s dose assignment. In case of non-emergency, PI must contact MM 
to discuss the options before unblinding the subject’s dose assignment. 
The Sponsor’s pharmacovigilance staff may unblind a subject’s dose assignment for an 
SAE, unanticipated adverse device effect (UADE), or adverse event of special interest 
(AESI) with the study product when the event is assessed as related and unexpected. If 
expedited regulatory reporting is required for an event, the report may be submitted to 
regulatory authorities with the subject’s dose assignment, in accordance with local 
regulations.  
5.3 
PACKAGING AND LABELING 
5.3.1 INO-4700 / SSC-0001 
This trial is randomized and blinded across study groups and placebo-controlled. 
Therefore, the subject and the Investigator’s clinical site personnel (except for the site 
pharmacy) are blinded to INO-4700 and SSC-0001. Each vial of investigational product 
will be labeled consistent with the example product label provided in the Investigator’s 
Brochure (IB). 
5.3.2 CELLECTRATM 2000 
Please see shipping box for shipping documents and contents, and User Manual for 
unpacking instructions. 
The CELLECTRATM 2000 device and its components bear labels that identify the device 
name and place of business of the manufacturer. The CELLECTRATM 2000 User Manual 
describes all relevant contraindications, hazards, potential risks and adverse effects, 
interfering substances or devices, warnings, and precautions. Each CELLECTRATM 2000 
Pulse Generator has a unique serial number, and each ID Applicator has a unique serial 
number. Each ID Array has a Lot Number and Expiration Date. Examples of device labels 
are provided in the IB. 
The CELLECTRATM 2000 device, and its components, will be shipped directly from the 
manufacturer to the study site. 
5.4 
HANDLING AND STORAGE 
5.4.1 INO-4700 AND SSC-0001 
INO-4700 and SSC-0001 will be shipped at 2–8°C. If the temperature monitoring devices 
in the shipping container(s) denote temperatures outside this 2–8°C (36-46°F) range, the 
Sponsor, or its designee, should be contacted immediately. 
Upon arrival, it must be transferred from the shipping container into 2–8°C (36-46°F) 
storage, in a secure area, in accordance with local regulations by designated unblinded 
personnel (e.g., pharmacy personnel). The Sponsor must be notified of any deviations 

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from this storage condition. Refrigerator temperature logs must be maintained at the 
clinical site and temperatures must be recorded and monitored regularly. For further 
details see Pharmacy Manual and IB. 
5.4.2 CELLECTRATM 2000 
See User Manual for operating and storage conditions. 
5.5 
PREPARATION AND DISPENSING 
INO-4700 is supplied in single dose 2-mL vials at a concentration of 10 mg/mL at a 
minimum volume of 0.4 mL. SSC-0001 is supplied in 10-mL vials at a minimum volume of 
2 mL. 
Blinded staff involved in the clinical execution of the study should not come in contact with 
vials of INO-4700 or SSC-0001. Vials will only be handled by designated unblinded 
personnel (e.g., pharmacy) at the site. When a participant is eligible for enrollment, 
unblinded personnel will fill INO-4700 or SSC-0001 into a blinded syringe in accordance 
with the subject’s randomization code. The syringe will be transferred to blinded site 
personnel for administration. The preparation and dispensing information is provided in 
the Pharmacy Manual. A randomization schedule will be generated by the Sponsor 
statistician. 
5.6 
USE OF STUDY DEVICE 
The CELLECTRATM 2000 is an investigational device. The instructions for use of the 
CELLECTRATM 2000 device are provided in the User Manual. Each clinical site will receive 
training for use of the CELLECTRATM 2000 device prior to first dose.  
The EP procedure must be performed by qualified personnel. Any individual designated 
to perform the procedure should be permitted by the relevant local authorities to administer 
parenteral injections to patients (e.g., MD, DO, RN) in addition to successfully completing 
device training from Sponsor personnel.  
5.7 
INVESTIGATIONAL DRUG AND STUDY DEVICE ACCOUNTABILITY 
5.7.1 INO-4700 AND SSC-0001 ACCOUNTABILITY 
It is the responsibility of the Investigator to ensure that a current record of investigational 
products accountability is maintained at the study site. The investigational products must 
have full traceability from the receipt of the products through participant use, disposal or 
return of the products. Records or logs must comply with applicable regulations and 
guidelines. The accountability information is provided in the Pharmacy Manual. 
5.7.2 CELLECTRATM 2000 ACCOUNTABILITY 
The investigative site is responsible for maintaining device accountability logs. The device 
must have full traceability from the receipt of the products through participant use, disposal 
or return of the products. The site must document acknowledgement of receipt and notify 
Inovio upon receipt of study devices. This includes the content shipped and condition upon 
receipt. 
For each subject administration, there must be a record of each product used for that 
participant, i.e., CELLECTRATM 2000 Pulse Generator serial number, ID Applicator serial 
number, and ID Array lot number. The ID Applicator is reusable with a new ID Array and 
sheath for each procedure. The sterile ID Array and sheath are single use only and must 

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be discarded after use in accordance with institutional policy regarding disposal of sharp 
needles/instruments. 
5.8 
RETURN AND DESTRUCTION OF INVESTIGATIONAL DRUG AND STUDY DEVICE 
5.8.1 INO-4700 AND SSC-0001 
Upon completion or termination of the study, all unused IP (INO-4700 and SSC-0001) 
must be destroyed at the study site in accordance with institution policy or returned to 
Inovio Pharmaceuticals, Inc. or its designee if the site cannot destroy IP. 
The used IP vials will be discarded in accordance with the site’s used IP disposal 
procedure. It is the Investigator’s responsibility to arrange for disposal of all empty vials, 
provided that procedures for proper disposal have been established in accordance with 
applicable national, local and institutional guidelines and procedures, and provided that 
appropriate records of disposal are kept. All precautions must be taken to maintain blind 
throughout this process. If requested by the Sponsor, the return of unused IP should be 
arranged by the responsible Inovio Representative. The unused IP can only be destroyed 
after being inspected and reconciled by the responsible Inovio Pharmaceuticals, Inc. 
personnel or designated unblinded Clinical Monitor. If IP is returned to Inovio 
Pharmaceuticals, Inc., or its designee, the IP must be accompanied by the appropriate 
documentation. The return of unused IP(s) should be arranged with the responsible Inovio 
personnel and/or unblinded Clinical Monitor. 
5.8.2 RETURN OF CELLECTRATM 2000 
Upon completion or termination of the study, an Inovio Representative will provide 
instructions regarding the component(s) to be returned to Inovio Pharmaceuticals, Inc., 
destroyed onsite or shipped to a destruction vendor. 
All product returned to Inovio Pharmaceuticals, Inc. must be accompanied by the 
appropriate return documentation. Returned supplies should be in the original containers. 
The return of all product identified above should be arranged by the Inovio Representative. 
The ID Arrays should be discarded in the sharps container immediately after use. The 
used ID Applicators can either be destroyed at the site, shipped to a destruction vendor, 
or returned to Inovio. If the used ID Applicators are destroyed on site, it is the Investigator’s 
responsibility to ensure that arrangements have been made for the disposal, written 
authorization has been granted by Inovio Pharmaceuticals, Inc., or its designee, 
procedures for proper disposal have been established in accordance with applicable 
regulation and guidelines and institutional procedures, and appropriate records of the 
disposal have been documented. 
6.0 
CLINICAL TRIAL PROCEDURES AND SCHEDULE 
The trial Schedule of Events (36TTables 4, 5 and 636T) in the Clinical Protocol Synopsis 
summarizes the trial procedures to be performed at each visit. Individual trial procedures 
are described in detail below. It may be necessary to perform these procedures at 
unscheduled time points if deemed clinically necessary by the Investigator. A subject will 
be required to provide informed consent (Section 6.2) prior to any study procedure being 
performed. Protocol waivers or exemptions will not be granted. Therefore, adherence to 
the study design and assessments are essential and required for study conduct. 

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6.1 
PROCEDURE BY VISIT 
Refer to Sections 6.1.1 and 6.1.2 for study procedures and the times at which they are to 
be performed. 
6.1.1 CLINICAL TRIAL SCREENING EVALUATIONS 
The assessments performed during Screening will determine the subject’s eligibility for 
the study and also their ability to comply with protocol requirements by completing all 
screening assessments. Participants’ post-menopausal status must meet requirements as 
specified in the inclusion criteria [63, 64]. The following screening evaluations will be 
performed within 60 days prior to dosing on Day 0. All screening assessment values must 
be reviewed prior to the first Study IP administration.  
If a subject does not meet an inclusion or exclusion criterion due to a transient and non-
clinically significant event at Screening, relevant Screening evaluations may be repeated 
within the same 60 day Screening period. If the participant fails twice, they will be 
considered a screen failure. 
 
Signed and dated informed consent (Section 6.2); 
 
Review and confirm all inclusion/exclusion criteria (Section 4.1 and 4.2); 
 
Obtain and document complete medical history, surgical history (including all past 
procedures), present conditions and concomitant illnesses (Section 6.1.1.1); 
 
Collect demographics, including gender, and document any ongoing, pre-existing 
conditions; 
 
Collect adverse events (Section 6.4.4); 
 
Record current concomitant medications/treatments (Section 6.4.7); 
 
Full physical examinations (Section 6.4); 
 
Record vital signs including body weight and height, heart rate (HR), respiratory 
rate (RR), blood pressure (BP) and oral temperature (Section 6.4); 
 
Collect blood for CBC with differential, serum chemistry (sodium [Na], potassium 
[K], chloride [Cl], bicarbonate [HCO3], calcium [Ca], phosphate [PO4], glucose, 
blood urea nitrogen [BUN] and creatinine [Cr]) and liver function [alanine 
aminotransferase (ALT) and aspartate aminotransferase (AST)] (Section 6.4); 
 
Perform 12 lead ECG (Section 6.4); 
 
Collect urine for routine urinalysis (Section 6.4); 
 
Collect blood for serum pregnancy test (Section 6.4); 
 
Collect serum for MERS-CoV (per PI discretion), HIV, Hepatitis B surface antigen 
(HBsAg) and Hepatitis C serology (Section 6.4) per national guidelines; 
 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
6.1.1.1 
Medical History 
A medical history will be obtained by the Investigator or qualified designee at the time of 
Screening. Medical history will include all active conditions, and any other past conditions, 
as well as surgical procedures, that are considered to be clinically significant by the 
Investigator and/or occurred within the 12 weeks prior to Screening. Illnesses first 
occurring or detected after the signing of the informed consent, or during the study and/or 
worsening of an existing illness in severity, frequency or nature after signing of the 
informed consent are to be documented as AEs on the CRF. Prior treatments, defined as 
administered up to 12 weeks prior to the time of informed consent and stopped prior to 
dosing on Day 0, should be recorded in the CRF as prior medications. Concomitant 
treatments, defined as continuing or new treatments taken at or after the signing of the 
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6.1.2 
CLINICAL TRIAL EVALUATIONS AND PROCEDURES 
Once eligibility has been confirmed, the participant will be assigned to receive IP. Visit 
dates and windows must be calculated from Day 0, unless otherwise noted. All study 
groups in Part 1 will be followed until Week 48, booster dose participants in Part 2 will be 
followed to Week 68 and all other participants in Part 2 who did not receive booster dose 
will be followed to Week 48. All participants will be followed in accordance with 
assessments outlined below. 
6.1.2.1 
Day 0  
The following evaluations will be performed on Day 0 prior to IP administration: 
 
Collect all present and/or new or ongoing adverse events; 
 
Document any present conditions and concomitant illnesses; 
 
Record current concomitant medications/treatments (Section 6.4.7); 
 
Targeted physical examination (Section 6.4); 
 
Record vital signs (Section 6.4); 
 
Collect urine for urine pregnancy test (Section 6.4); 
 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
 
The following evaluation will be performed on Day 0 prior to EP: 
 
Assess for injection site for IP leakage (Section 6.4.1) 
 
The following evaluations will be performed on Day 0 after IP plus EP administration: 
 
Collect any new adverse events; 
 
Download EP Data (Section 6.4.1.1). 
6.1.2.2 
Week 2 
Calculated from Day 0, the following evaluations will be performed at this visit: 
 
Collect all present and/or new or ongoing adverse events; 
 
Document any present conditions and concomitant illnesses; 
 
Record current concomitant medications/treatments (Section 6.4.7); 
 
Targeted physical examination (Section 6.4); 
 
Record vital signs (Section 6.4); 
 
Collect blood for CBC with differential, serum chemistry and liver function (Section 
6.4); 
 
Collect urine for routine urinalysis (Section 6.4); 
 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
6.1.2.3 
Week 4 
Part 1 
The following evaluations will be performed on Week 4 (complete prior to IP 
administration for Part 1 Study Groups A, B, E, F and I): 
 
Collect all present and/or new or ongoing adverse events; 
 
Document any present conditions and concomitant illnesses; 
 
Record current concomitant medications/treatments (Section 6.4.7); 
 
Targeted physical examination (Section 6.4); 
 
Record vital signs (Section 6.4); 

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 
Collect urine for urine pregnancy test (Section 6.4) for Part 1 Study Groups A, B, 
E, F and I only. 
 
The following evaluation will be performed on Week 4 prior to EP (for Part 1 Study 
Groups A, B, E, F and I only): 
 
Assess for injection site for IP leakage (Section 6.4.1) 
 
The following evaluations will be performed on Week 4 after IP administration (for Part 
1 Study Groups A, B, E, F and I only): 
 
Collect any new adverse events; 
 
Download EP Data (Section 6.4.1.1). 
 
Part 2 if Day 0/Week 4 Dosing Regimen is Optimal 
The following evaluations will be performed on Week 4 (complete prior to IP 
administration if following Table 5): 
 
Collect all present and/or new or ongoing adverse events; 
 
Document any present conditions and concomitant illnesses; 
 
Record current concomitant medications/treatments (Section 6.4.7); 
 
Targeted physical examination (Section 6.4); 
 
Record vital signs (Section 6.4); 
 
Collect urine for urine pregnancy test (Section 6.4). 
 
The following evaluation will be performed on Week 4 prior to EP (if following Table 5 
only): 
 
Assess for injection site for IP leakage (Section 6.4.1) 
The following evaluations will be performed on Week 4 after IP administration (if 
following Table 5 only): 
 
Collect any new adverse events; 
 
Download EP Data (Section 6.4.1.1). 
 
Part 2 if Day 0/Week 8 Dosing Regimen is Optimal 
The following evaluation will be collected on Week 4 (if following Table 6 only) during a 
follow-up phone call visit: 
 
Collect all present and/or new or ongoing adverse events. 
6.1.2.4 
Week 6 
Calculated from Week 4 if Week 4 is a dosing visit, the following evaluations will be 
performed at this visit for Part 1 and Part 2 if Day 0/Week 4 dosing regimen is optimal: 
 
Collect all present and/or new or ongoing adverse events; 
 
Document any present conditions and concomitant illnesses; 
 
Record current concomitant medications/treatments (Section 6.4.7); 
 
Targeted physical examination (Section 6.4); 
 
Record vital signs (Section 6.4); 
 
Collect blood for CBC with differential, serum chemistry and liver function(Section 
6.4); 
 
Collect urine for routine urinalysis (Section 6.4); 

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 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
6.1.2.5 
Week 8 
Part 1 
The following evaluations will be performed on Week 8 (complete prior to IP 
administration for Part 1 Study Groups C, D, G and H): 
 
Collect all present and/or new or ongoing adverse events; 
 
Document any present conditions and concomitant illnesses; 
 
Record current concomitant medications/treatments (Section 6.4.7); 
 
Targeted physical examination (Section 6.4); 
 
Record vital signs (Section 6.4); 
 
Collect urine for urine pregnancy test (Section 6.4) for Part 1 Study Groups C, D, 
G and H only. 
 
The following evaluation will be performed on Week 8 prior to EP (for Part 1 Study 
Groups C, D, G and H only): 
 
Assess for injection site for IP leakage (Section 6.4.1) 
 
The following evaluations will be performed on Week 8 after IP administration (for Part 
1 Study Groups C, D, G and H only): 
 
Collect any new adverse events; 
 
Download EP Data (Section 6.4.1.1). 
 
Part 2 if Day 0/Week 4 Dosing Regimen is Optimal 
The following evaluation will be collected on Week 8 (if following Table 5 only) during a 
follow-up phone call visit: 
 
Collect all present and/or new or ongoing adverse events. 
 
Part 2 if Day 0/Week 8 Dosing Regimen is Optimal 
The following evaluations will be performed on Week 8 (complete prior to IP 
administration if following Table 6): 
 
Collect all present and/or new or ongoing adverse events; 
 
Document any present conditions and concomitant illnesses; 
 
Record current concomitant medications/treatments (Section 6.4.7); 
 
Targeted physical examination (Section 6.4); 
 
Record vital signs (Section 6.4); 
 
Collect urine for urine pregnancy test (Section 6.4). 
 
The following evaluation will be performed on Week 8 prior to EP (if following Table 6 
only): 
 
Assess for injection site for IP leakage (Section 6.4.1) 
 
The following evaluations will be performed on Week 8 after IP administration (if 
following Table 6 only): 
 
Collect any new adverse events; 
 
Download EP Data (Section 6.4.1.1). 

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6.1.2.6 
Week 10 
Calculated from Week 8 if Week 8 is a dosing visit, the following evaluations will be 
performed at this visit for Part 1 and Part 2 if Day 0/Week 8 dosing regimen is optimal: 
 
Collect all present and/or new or ongoing adverse events; 
 
Document any present conditions and concomitant illnesses; 
 
Record current concomitant medications/treatments (Section 6.4.7); 
 
Targeted physical examination (Section 6.4); 
 
Record vital signs (Section 6.4); 
 
Collect blood for CBC with differential, serum chemistry and liver function (Section 
6.4); 
 
Collect urine for routine urinalysis (Section 6.4); 
 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
6.1.2.7 
Week 12  
The following evaluations will be performed at this visit: 
 
Collect all present and/or new or ongoing adverse events; 
 
Document any present conditions and concomitant illnesses; 
 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
6.1.2.8 
Week 30 
The following evaluations will be collected during the follow-up phone call visit: 
 
Collect all present and/or new or ongoing adverse events. 
6.1.2.9 
Week 48  
Part 1 
The following evaluations will be performed at this visit (End of Study visit): 
 
Collect all present and/or new or ongoing adverse events; 
 
Document any present conditions and concomitant illnesses; 
 
Record current concomitant medications/treatments (Section 6.4.7); 
 
Full physical examination (Section 6.4); 
 
Record vital signs (Section 6.4); 
 
Collect blood for CBC with differential, serum chemistry and liver function (Section 
6.4); 
 
Collect urine for routine urinalysis (Section 6.4); 
 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
 
Part 2  
The Week 48 visit will be the End of Study visit for participants receiving only two doses. 
The Week 48 visit will be the last dosing visit for participants receiving three doses. The 
following evaluations will be performed on Week 48 (complete prior to IP administration 
for Part 2 participants receiving a third/booster dose): 
 
Collect all present and/or new or ongoing adverse events; 
 
Document any present conditions and concomitant illnesses; 
 
Record current concomitant medications/treatments (Section 6.4.7); 

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 
Targeted physical examination (Section 6.4) for Part 2 participants receiving a 
third/booster dose; 
 
Full physical examination (Section 6.4) for Part 2 participants receiving two doses 
only; 
 
Record vital signs (Section 6.4); 
 
Collect blood for CBC with differential, serum chemistry and liver function (Section 
6.4); 
 
Collect urine for routine urinalysis (Section 6.4); 
 
Collect urine for urine pregnancy test (Section 6.4) for Part 2 participants receiving 
a third/booster dose; 
 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
 
The following evaluation will be performed on Week 48 prior to EP (for Part 2 
participants receiving a third/booster dose only): 
 
Assess for injection site for IP leakage (Section 6.4.1) 
 
The following evaluations will be performed on Week 48 after IP administration (for Part 
2 participants receiving a third/booster dose only): 
 
Collect any new adverse events; 
 
Download EP Data (Section 6.4.1.1). 
6.1.2.10 
Week 50  
The following evaluations will be performed at this visit only for Part 2 participants 
receiving a third/booster dose: 
 
Collect all present and/or new or ongoing adverse events; 
 
Document any present conditions and concomitant illnesses; 
 
Record current concomitant medications/treatments (Section 6.4.7); 
 
Targeted physical examination (Section 6.4); 
 
Record vital signs (Section 6.4.); 
 
Collect blood for CBC with differential, serum chemistry and liver function (Section 
6.4); 
 
Collect urine for routine urinalysis (Section 6.4); 
 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
6.1.2.11 
Week 68  
The following evaluations will be performed at this visit (End of Study Visit) only for Part 
2 participants receiving a third/booster dose: 
 
Collect all present and/or new or ongoing adverse events; 
 
Document any present conditions and concomitant illnesses; 
 
Record current concomitant medications/treatments (Section 6.4.7); 
 
Full physical examination (Section 6.4); 
 
Record vital signs (Section 6.4); 
 
Collect blood for CBC with differential, serum chemistry and liver function (Section 
6.4); 
 
Collect urine for routine urinalysis (Section 6.4); 
 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 

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6.2 
INFORMED CONSENT 
All participants must sign the informed consent prior to participating in any clinical trial-
related procedures. The informed consent documentation must be in compliance with 
applicable regulations and GCP. Qualified clinical trial personnel will: 
 
Meet with prospective clinical trial participants 
 
Explain the clinical trial 
 
Provide clinical trial participants with an Informed Consent Form (ICF) that includes 
the following in a language that is understandable to the subject: 
 
Screening test(s) description 
 
Eligibility criteria for entering the clinical trial 
 
Clinical trial treatments and follow-up procedures description 
 
Explanation of the clinical trial, including but is not limited to: 
 
Clinical trial objectives 
 
Potential benefits and risks 
 
Discomforts/inconveniences 
 
Subject’s rights and responsibilities 
The subject or subject’s legally authorized representative is then requested to sign and 
date the ICF. A copy of the signed informed consent documentation must be provided to 
the subject or subject’s legally authorized representative. The qualified clinical trial 
personnel will document the process of obtaining informed consent within the source 
record. Signed ICFs are maintained in the subject’s source records and must be 
accessible for verification at any time. Signing of the ICF begins the 60 day screening 
window. 
6.3 
ASSIGNMENT OF SUBJECT IDENTIFICATION NUMBERS 
Each subject who consents will be assigned a unique subject identification number (SID), 
which identifies the subject for all clinical trial-related procedures. SIDs are a combination 
of a four digit site code and a four digit subject number starting with 0001. After SIDs are 
assigned, they cannot be reused or reassigned for any reason. Information regarding the 
SID and screen date will be documented on a screening and enrollment log/system and 
in the Case Report Form (CRF). 
Participants meeting eligibility criteria listed in the protocol will be randomized by a 
computer generated allocation schedule. 
6.4 
SAFETY EVALUATIONS 
PHYSICAL EXAM AND TARGETED PHYSICAL ASSESSMENTS 
A full physical examination will be conducted during Screening and at study discharge/End 
of Study visit (i.e., Week 48, Week 68 or any other study discontinuation visit). A targeted 
physical assessment will be performed at other visits as determined by the Investigator or 
directed per subject complaints. 
VITAL SIGNS 
Vital signs including oral temperature, respiration rate, blood pressure and heart rate will 
be measured at Screening and at select visits during the study.  
HEIGHT AND WEIGHT 

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Weight (kg) and height (cm) will be collected at Screening. 
12-LEAD ECG 
A single 12-lead ECG will be performed at Screening for all participants to determine 
eligibility. ECG results obtained within 60 days of Day 0 are acceptable. The ECG should 
include measurements of ventricular rate, PR, QRS, QT, QTcb or QTcf, as well as an 
assessment of whether the ECG is normal or abnormal. Abnormal ECGs should be 
interpreted as clinically significant or not clinically significant. Dosing will be delayed in the 
event of a clinically significant abnormal pre-dose ECG until it has been reviewed by the 
PI, qualified PI designee, MM or Sponsor consultant cardiologist and deemed safe to 
proceed. 
LABORATORY EVALUATIONS 
At Screening and select visits during the study, blood samples will be collected for safety 
assessments. Approximately 400 mL and 340-460 mL of blood will be drawn from each 
subject in Part 1 and Part 2, respectively, over the course of the study. Participants may 
be asked to come back for additional blood draws if collected blood sample is lost or 
unevaluable for any reason. 
Hematology [Complete blood count (CBC) with automated differential]: 
White blood cell (WBC) count, red blood cell (RBC) count, hemoglobin, hematocrit and 
platelet count will be measured at Screening and select visits during the study. 
Serum chemistry: 
Electrolytes [Sodium (Na), Potassium (K), Chloride (Cl), Bicarbonate (HCO3), Calcium 
(Ca), Phosphate (PO4)], glucose, BUN (blood urea nitrogen), and Creatinine (Cr) will be 
measured at Screening and select visits during the study. 
Liver function: 
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) will be measured 
at Screening and select visits during the study. 
Urinalysis:  
Urine samples will be tested by dipstick for glucose, protein, and hematuria at Screening 
and select visits during the study. If abnormal (presence of protein, hematuria, or glucose 
≥ 1+), a microscopic examination should be performed.  
Serology: 
Antibodies to MERS-CoV (per PI discretion), Hepatitis B surface antigen (HBsAg), 
Hepatitis C antibody and HIV antibody or rapid test will be measured at Screening only. 
Pregnancy Testing:  
For women of child bearing potential (WOCBP), a serum pregnancy test will be obtained 
at Screening and a urine pregnancy test will be performed prior to any dosing. A negative 
result for urine β-HCG (test must have a sensitivity of at least 25 mIU/mL) must be 
available prior to each administration of IP. If the β-HCG test is positive, indicating that the 
participant is pregnant prior to completing the specified dose regimen, then no further IP 
will be administered. Every attempt should be made to follow pregnant participants for the 
remainder of the study and to determine the outcome of the pregnancy. 
 

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6.4.1 
INJECTION AND EP  
Participants in Part 1 Study Groups A, B and C will receive one injection of INO-4700 in 
a volume of ~0.1 mL by ID injection above an acceptable muscle location for injection, 
the injection site is assessed for IP leakage, and the injection is followed immediately by 
EP. Part 1 Study Groups D and E will receive two injections of INO-4700, each in a 
volume of ~0.1 mL, above an acceptable muscle location on two different limbs, the 
injection site is assessed for IP leakage, and the injection is followed immediately by EP. 
Part 1 Study Groups F and G will receive one injection of placebo in a volume of ~0.1 mL 
by ID injection above an acceptable muscle location for injection, the injection site is 
assessed for IP leakage, and the injection is followed immediately by EP. Part 1 Study 
Groups H and I will receive two injections of placebo, each in a volume of ~0.1 mL, above 
an acceptable muscle location on two different limbs, the injection site is assessed for IP 
leakage, and the injection is followed immediately by EP. 
 
Participants in Part 2 will receive one or two injections per dosing visit of the optimal dose 
of INO-4700 or placebo in volume of ~0.1 mL by ID injection above an acceptable skin 
location for injection, the injection site is assessed for IP leakage, and the injections is 
followed immediately by EP.  
 
Only if the deltoid muscle is not a suitable location (see exclusion criterion ‘h’), the ID 
injection can then be administered above the lateral quadriceps followed immediately by 
EP. IP must not be given within 2 cm of a tattoo, scar, keloid, previous injection site at the 
same dosing visit, or active lesion/rash. Also, ID injection followed immediately by EP must 
not be performed on the skin of an extremity which has any metal implants or implantable 
medical device (e.g., surgical rods, pins or joint replacements). If a subject has an 
implanted cardiac defibrillator or pacemaker, ID injection/EP must not be performed above 
the deltoid muscle on the same side of the body where the device is located. 
6.4.2 
MANAGEMENT OF ANXIETY AND PAIN DUE TO ELECTROPORATION (EP) 
PROCEDURES 
Participants may be offered topical anesthetic (e.g., EMLA or equivalent) to prevent 
discomfort from the injection/EP procedure. If a topical anesthetic is used, an approximate 
1.5 cm diameter amount will be applied without occlusion to the administration site ~30 
minutes prior to injection/EP.  
Participants may be offered a mild sedative (e.g., 0.5-1 mg lorazepam or equivalent) for 
anxiety related to the injection/EP procedure. Mild sedatives may be administered 
approximately 1 hour prior to injection/EP on dosing visits. Participants who receive a mild 
sedative must not be allowed to operate a motor vehicle for 3-4 hours after receiving 
medication and should have arranged transportation to depart the study site. 
In case of pain, participants may be treated with a non-narcotic analgesic (e.g., ibuprofen, 
ketorolac) after injection/EP.  
Participants who are allergic to or have contraindications to EMLA, ibuprofen, ketorolac or 
a mild sedative may be offered a suitable alternative. 
Medication taken for pain management will be documented as concomitant medications. 
6.4.3 
ASSESSMENT OF LABORATORY ABNORMALITIES 
Blood will be drawn for serum chemistry, liver function, and hematology and urinalysis 
performed at the visits listed in the Schedule of Events (Tables 3, 4 and 5) as listed in 
Section 6.4.  

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Laboratory AEs will be assessed and graded in accordance with the “Toxicity Grading 
Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical 
Trials”, issued in September 2007 (Appendix A). 
6.4.4 
ASSESSMENT OF CLINICAL TRIAL ADVERSE EVENTS (AES) 
Participants will be queried regarding the occurrence of any adverse events including 
adverse events related to injection site reactions, concomitant medications and new onset 
illness or disease during their study visits. Participants will be reminded to contact study 
personnel and immediately report any event for the duration of the study. All adverse 
events will be captured from the time of the informed consent to 12 weeks from Day 0. 
Subsequently, only related adverse events, adverse events of special interest and serious 
adverse events will be collected until study discharge. These events will be recorded on 
the subject’s CRF. 
6.4.5 
ASSESSMENT OF INJECTION SITE REACTIONS  
The IP administration procedure consists of an ID injection (formation of a wheal) of IP 
followed by insertion of the ID Array needles (electrodes) through the skin and into the 
wheal followed by delivery of the electroporation pulses. This procedure is broadly 
described as administration because it involves more than the injection of a drug. 
Consequently, reactions arising from the IP administration procedure may be reported as 
administration site or injection site reactions. When evaluating administration (injection) 
site reactions throughout the study, it is most important to be as specific as possible by 
selecting the most appropriate term (see Table 7 below) and use the grading scale as 
listed in the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled 
in Preventive Vaccine Clinical Trials, issued September 2007 (Appendix A). Administration 
(injection) site reactions and administration site pain will be evaluated starting 30 minutes 
following injection/EP. In addition, other events associated with administration (injection) 
site reactions (e.g., hematoma, infection or necrosis) should also be reported with 
preferred terms specific for administration (injection) site reactions.  
Table 7: Grading Scale for Injection Site Reactions 
Local Reaction to 
Injectable Product 
(Grade) 
Mild (1) 
Moderate (2) 
Severe (3) 
Potentially Life 
Threatening (4) 
Pain 
Does not 
interfere with 
activity 
Repeated use 
of non-narcotic 
pain reliever 
>24 hours or 
interferes with 
activity 
Any use of 
narcotic pain 
reliever or 
prevents daily 
activity 
Emergency room 
visit or 
hospitalization 
Tenderness 
Mild discomfort 
to touch 
Discomfort with 
movement 
Significant 
discomfort at 
rest 
ER visit or 
hospitalization 
Erythema/Rednessa 
2.5-5 cm 
5.1-10 cm 
>10 cm 
Necrosis or 
exfoliative 
dermatitis 
Induration/Swellingb 
2.5-5 cm and 
no interference 
w/ activity 
5.1-10 cm or 
interferes with 
activity 
>10 cm or 
prevents daily 
activity 
Necrosis 

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September 2007 “FDA Guidance for Industry-Toxicity Grading Scale for Healthy Adult and 
Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials” 
a In addition to grading the measured local reaction at the greatest single diameter, the 
measurement should be recorded as a continuous variable 
b Should be evaluated and graded using the functional scale as well as the actual measurement. 
6.4.6 
PERIPHERAL BLOOD IMMUNOGENICITY ASSESSMENTS 
Whole blood and serum samples will be obtained to assess overall immune response. 
Immunology blood and serum samples are to be collected at Screening and select visits 
during the study. Both Screening and Day 0 immunology samples are required to enable 
all immunology testing. Details of the immunology sample collection and shipment 
information will be provided in the Laboratory Manual. The T and B cell immune responses 
to INO-4700 will be measured using assays that include but are not limited to ELISA, 
neutralization, assessment of immunological gene expression, assessment of 
immunological protein expression, flow cytometry and ELISPOT.  
An immune responder is defined as having either an increase in vaccine antibody titer 
compared to baseline or an increase in the number of vaccine specific IFN-gamma 
secreting cells as compared to baseline.   
Determination of analysis of collected samples for immunological endpoints will be 
determined on an ongoing basis throughout the study. 
6.4.7 
CONCOMITANT MEDICATIONS/TREATMENTS 
All medications (prescription and nonprescription) taken at the time of Screening and 
ongoing from signing of the informed consent to study discharge that do not affect a 
subject’s eligibility for participation (see Section 4.2) must be recorded on the case report 
forms (CRFs). 
Actual or estimated start and stop dates must be provided. This information will be 
obtained from the subject and abstracted from any available medical records. The 
indication for the medication, dose, and dose regimen will be documented.  
Therapy considered necessary for the subject’s welfare may be given at the discretion of 
the Investigator. If the permissibility of a specific medication/treatment is in question, 
please contact the Sponsor. 
The decision to administer a prohibited medication/treatment (Section 6.4.8) is made with 
the safety of the clinical trial subject as the primary consideration. When possible, the 
Sponsor should be notified before the prohibited medication/treatment is administered. 
6.4.8 
RESTRICTIONS  
Participants should refrain from becoming pregnant until 1 month following the last dose 
of investigational product by using appropriate contraceptive measures (see Section 4.1). 
Participants must not be vaccinated (e.g., influenza vaccine) within 2 weeks prior to the 
first dose of INO-4700 or placebo, or within 2 weeks of (before or after) any subsequent 
dose of investigational product. 
Participants must not receive a course of systemic corticosteroids (≥2 mg/kg of prednisone 
or equivalent for 5 days) within 3 months prior to any dose of investigational product. 
Participants must not have fever (oral temperature >38.0 degrees Celsius or 100.4 
degrees Fahrenheit) within 72 hours prior to each dose of investigational product. 

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7.0 
EVALUATION OF SAFETY AND MANAGEMENT OF TOXICITY 
7.1 
SAFETY PARAMETERS 
The safety of INO-4700 will be measured and graded in accordance with the “Toxicity 
Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive 
Vaccine Clinical Trials”, issued September 2007 (Appendix A). 
7.2 
ADVERSE EVENTS (AES) 
Any untoward medical occurrence in a patient or clinical investigation subject administered 
a pharmaceutical product and which does not necessarily have to have a causal 
relationship with this treatment.  
An AE can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding, for example), symptom, or disease temporally associated with the use 
of a medicinal product, whether or not considered related to the medicinal product.  
Adverse Events (AEs) include the following: 
 Pre- or post-treatment complications that occur as a result of protocol mandated 
procedure during or after screening (before the administration of clinical trial drug) 
 Any pre-existing condition that increases in severity, or changes in nature during or as 
a consequence of the clinical trial drug administration phase 
 Complications of pregnancy (refer to Section 7.11) 
Adverse Events (AEs) do not include the following: 
 Medical or surgical procedures (e.g., surgery, endoscopy, tooth extraction, transfusion) 
performed; however, the condition that leads to the procedure is an AE 
 Pre-existing diseases or conditions or laboratory abnormalities present or detected 
before the Screening Visit that do not worsen 
 Situations where an untoward medical occurrence has not occurred (e.g., 
hospitalization for elective surgery, social and/or convenience admissions) 
 Overdose without clinical sequelae 
 Any medical condition or clinically significant laboratory abnormality with an onset date 
before the ICF is signed, is not an AE; it is considered to be pre-existing and will be 
documented on the medical history CRF 
 Uncomplicated pregnancy 
 An induced elective abortion to terminate a pregnancy without medical reason 
7.3 
ADVERSE DRUG REACTION (ADR) 
All noxious and unintended responses to a medicinal product related to any dose. This 
means that a causal relationship between the medicinal product and an adverse event is 
at least a reasonable possibility (i.e., the relationship cannot be ruled out). 
7.4 
SERIOUS ADVERSE EVENTS (SAES) 
An SAE is any untoward medical occurrence that at any dose: 
 Results in death  
 Is life-threatening 

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o Refers to an event in which the participant was at risk of death at the time of the 
event. It does not refer to an event which hypothetically might have caused death 
if it were more severe. 
 Requires inpatient hospitalization or prolongation of existing hospitalization 
o Includes any hospitalization in which the participant has been admitted to the 
hospital regardless the length of stay, even if the hospitalization is only a 
precautionary measure to allow continued observation. However, hospitalization 
(including hospitalization for an elective procedure) for a pre-existing condition that 
has not worsened, does not constitute an SAE. 
 Results in persistent or significant disability/incapacity 
o A substantial disruption of a person's ability to conduct normal life functions (i.e., 
the adverse event resulted in a significant, persistent or permanent change, 
impairment, damage or disruption in the participant's body function/structure, 
physical activities and/or quality of life). 
 Results in congenital anomaly or birth defect and/or 
 An important medical event  
o An event that may not be immediately life-threatening or result in death or 
hospitalization but may jeopardize the participant or may require intervention to 
prevent one of the other outcomes listed above. Examples of such events are 
intensive treatment in an emergency room or at home for allergic bronchospasm, 
blood dyscrasias or convulsions that do not result in hospitalization, or 
development of drug dependency or drug abuse. 
Clarification of Serious Adverse Events (SAEs) 
 Death in itself is not an AE. Death is an outcome of an AE, but when the cause of death 
has not been provided, use the event term: death of unknown cause. 
 The participant may not have been receiving an investigational medicinal product at the 
occurrence of the event. 
 Complications that occur during hospitalizations are AEs. If a complication prolongs the 
hospitalization, it is an SAE. 
7.5 
UNEXPECTED ADVERSE DRUG REACTION 
An adverse reaction, the nature or severity of which is not consistent with the applicable 
product information (e.g., Investigator’s Brochure [IB] for an unapproved investigational 
product, package insert/summary of product characteristics for an approved product). 
7.6 
UNANTICIPATED (SERIOUS) ADVERSE DEVICE EFFECT (UADE) 
A UADE is any serious adverse effect on health or safety or any life-threatening problem 
or death caused by, or associated with, a device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the investigational plan 
or application (including a supplementary plan or application), or any other unanticipated 
serious problem associated with a device that relates to the rights, safety, or welfare of 
participants.  
A UADE is a type of SAE that requires reporting to the Sponsor in accordance with Section 
7.9. 

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7.7 
DEVICE DEFICIENCY 
A device deficiency is an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. 
Note: Device deficiencies include malfunctions, use errors and inadequate labelling. 
7.8 
SAFETY AND TOXICITY MANAGEMENT 
The Medical Monitor is responsible for the overall safety monitoring of the clinical trial. 
Safety monitoring assessments include but are not limited to:  
 Incidence of all adverse events classified by system organ class, preferred term, 
severity and causal relationship to clinical trial treatment 
 Changes in laboratory parameters 
 Local and systemic injection site review; special attention will be paid to the examination 
of the injection site 
7.8.1 
ADVERSE EVENT OF SPECIAL INTEREST (AESI)  
An adverse event of special interest (serious or non-serious) is one of scientific and 
medical concern specific to the Sponsor’s product or program, for which ongoing 
monitoring and rapid communication by the PI to the Sponsor can be appropriate.  
For the purpose of this clinical trial, the AESIs listed in Appendix B are to be reported to 
the Sponsor in accordance with Section 7.9. 
7.8.2 
ABNORMAL LABORATORY VALUE 
The PI will annotate each abnormal lab value as clinically significant (CS) or not clinically 
significant (NCS). 
Laboratory values that are NCS in the PI’s opinion should not be reported as an adverse 
event. 
Any abnormal laboratory value that is new in onset or worsened in severity or frequency 
from the baseline condition and meets one of the following criteria will be recorded as an 
AE: 
 
Requires therapeutic intervention or diagnostic tests 
 
Leads to discontinuation of further administration of the investigational product in 
the clinical trial 
 
Has accompanying or inducing symptoms or signs 
 
Is judged by the PI as clinically significant (CS) 
Abnormal laboratory values that meet the criteria of an AE or SAE should be reported in 
accordance with Section 7.9. 
7.8.3 
CLINICAL TRIAL STOPPING RULES 
The stopping rules for this study are any of the following: 
 
Any study treatment-related SAE. 
 
Any Grade 4 toxicities related to study treatment. 

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CONFIDENTIAL 
Protocol Version: v1.0 
 
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If medical records are submitted to the Sponsor with the SAE Report Form, the clinical 
trial site must: 
 Redact the medical records of all personal data (e.g., confidential subject data, 
Personal Identifying Information [PII]) 
 Provide the subject’s assigned identification number (SID) on the records 
7.10 ADVERSE EVENT REPORTING 
This section provides details on reporting the safety information. 
7.10.1 SUBMITTING THE INITIAL SERIOUS ADVERSE EVENT (SAE) REPORT FORM 
The PI should include as much safety information as possible when submitting the initial 
report, but the report must include the following at a minimum:  
 
The adverse event 
 
The subject’s assigned identification number (SID) 
 
Investigational product(s) (IP) and/or study device 
 
Investigator causal relationship to the IP(s) and/or study device 
 
Serious criteria 
 
Reporter name and contact information 
If a case is submitted to the Sponsor with only the “minimum” information, a more detailed 
or updated follow-up report will be sent to the Sponsor as soon as possible but no later 
than three (3) calendar days after the date of the initial report. 
7.10.2 RECORDING THE EVENT 
Principal Investigators (PIs) should use correct medical terminology/concepts when 
recording adverse events on the EDC and SAE Report Form. The use of colloquialisms 
and abbreviations should be avoided. 
A medical diagnosis, if known, should be recorded rather than individual signs and 
symptoms. However, if the signs and/or symptoms cannot be medically characterized as 
a single diagnosis or syndrome, each individual sign and/or symptom should be recorded. 
If a diagnosis is subsequently established, all previous signs and/or symptoms will be 
subsumed and replaced with a single medical diagnosis. 
7.10.3 ASSESSING SEVERITY (INTENSITY) 
Severity is used to describe the intensity of a specific event (e.g., mild, moderate, severe). 
The PI will assess and grade clinical AEs or SAEs (based on discussions with clinical trial 
participants) in accordance with Toxicity Grading Scale for Healthy Adult and Adolescent 
Volunteers Enrolled in Preventive Vaccine Clinical Trials (Food and Drug Administration 
[FDA] Guidance for Industry) (Appendix A). 
7.10.4 CAUSAL RELATIONSHIP OF CLINICAL MATERIAL TO ADVERSE EVENTS (AES) 
A causally related AE is one judged to have a possible, probable or definite relationship 
to the administration of the IP and/or the study device. An AE may also be assessed as 
not related to the IP and/or the study device. Because the PI is knowledgeable about the 

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subject (e.g., medical history, concomitant medications), administers the IP, and monitors 
the subject’s response to the IP, the PI is responsible for reporting AEs and judging the 
relationship between the administration of the IP and EP and a subsequent AE. The PI is 
aware of the subject’s clinical state and may have observed the event, and thus may be 
sensitive to distinctions between events due to the underlying disease process versus 
events that may be product-related.  
Principal Investigators (PIs) should use their knowledge of the clinical trial subject, the 
circumstances surrounding the event, and an evaluation of any potential alternative 
causes to determine whether an AE is considered to be related to the IP and/or the study 
device and the causal relationship reported as "Yes" or "No" accordingly. Causality should 
be assessed by the PI as related to drug, related to device, or related to both drug and 
device (i.e., related to both or indiscernible) by the following criteria: 
 
Yes – there is a reasonable possibility that administration of the clinical trial 
treatment (drug or device or both drug and device) contributed to the event 
 
No – there is no reasonable possibility that administration of the clinical trial 
treatment contributed to the event and there are more likely causes 
The following guidance should also be taken into consideration: 
 
Temporal relationship of event to administration of IP and/or EP 
 
Course of the event, considering especially the effects of dose reduction, 
discontinuation of IP, or reintroduction of IP (where applicable) 
 
Known association of the event with the IP, EP or with similar treatments 
 
Known association of the event with the disease under trial 
 
Presence of risk factors in the clinical trial participant or use of concomitant 
medications known to increase the occurrence of the event 
The rationale for the PI’s causal assessment is to be recorded on the SAE Report Form. 
The Sponsor will assess the overall safety of the IP delivered by EP and determine 
whether to report expeditiously to the regulatory authority(ies). 
7.11 REPORTING PREGNANCY DURING THE CLINICAL TRIAL 
Participants who are pregnant or expect to become pregnant during the course of the 
clinical trial will be excluded from participation in the clinical trial.  
All pregnancies that occur from the time of first administration of clinical trial treatment 
through study completion (Part 1 – Week 48 and Part 2 – Week 48 or Week 68) will be 
reported to the Sponsor. If clinical trial site staff become aware that a subject becomes 
pregnant after enrolling in the clinical trial, she will not be given any additional treatments 
with the IP. A Pregnancy Form will be completed by the PI and submitted to the Sponsor 
within 24 hours after becoming aware of the pregnancy. 
The PI will report this event to their IRB/REB/EC in accordance with their policies and 
procedures.  
The clinical trial site must request the subject’s permission to query pregnancy outcome 
and follow the subject for outcome of the pregnancy. The subject will continue to be 
followed for safety assessments without receiving additional IP until clinical trial discharge 
in accordance with this protocol. Procedures that are contraindicated during pregnancy, 
including additional treatments, must not be performed. The PI should use clinical 

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judgment regarding subsequent clinical trial-related blood collection based on the 
presence or absence of anemia in each subject.  
Male participants will be instructed through the ICF to immediately inform the PI if their 
partner becomes pregnant until study completion. A Pregnancy Form will be completed 
by the PI and submitted to the Sponsor within 24 hours after becoming aware of the 
pregnancy. The pregnant partner will be asked to sign an Authorization for Use and 
Disclosure of Pregnancy Health Information to allow for follow-up on her pregnancy. If the 
authorization has been signed, the PI will collect and report details of the course and 
outcome of the pregnancy in the partner of a male subject exposed to IP. The PI will 
update the Pregnancy Form with additional information on the course and outcome of the 
pregnancy and submit the form to the Sponsor.  
If a PI is contacted by the male subject or his pregnant partner, the PI may provide 
information on the risks of the pregnancy and the possible effects on the fetus to support 
an informed decision in cooperation with the treating physician and/or obstetrician. 
If the end of the pregnancy occurs after the clinical trial has been completed, the outcome 
will be reported directly to the Sponsor. 
7.12 REPORTING DEVICE-RELATED COMPLAINTS OR DEFICIENCIES 
All product complaints that meet the definition of device deficiency must be reported to the 
Sponsor within 10 days of discovery, with the exception of SAEs which require 24-hour 
reporting. The error reporting or complaint form must be completed and emailed to the 
Sponsor at clinicalcomplaint@inovio.com. 
Device deficiencies include malfunctions, misuse or use errors and inadequate labeling. 
A malfunction is defined as the failure of a device to meet its performance specifications 
or otherwise perform as intended. The intended performance of a device refers to the 
intended use for which the device is labeled or marketed. 
Any problems experienced during the treatment procedure including potential 
malfunctions of the device, error messages displayed on the device screen following 
treatment, or errors that occur during the treatment procedure must immediately be 
reported to the Sponsor or its designee for evaluation.  
7.13 NOTIFYING REGULATORY AUTHORITIES AND INSTITUTIONAL REVIEW BOARDS 
(IRBS)/RESEARCH ETHICS BOARDS (REBS)/ETHICS COMMITTEES (ECS) OF SAFETY 
INFORMATION 
7.13.1 SPONSOR RESPONSIBILITIES 
 
Determine whether the safety information meets the requirements for expedited 
reporting to the applicable regulatory authorities 
 
Prepare and submit the safety report to the applicable regulatory authorities 
 
Send all participating PIs a safety report and Investigator Safety Letter (i.e., Dear 
Investigator Letter) that will include a statement if there is or is not any significant new 
safety information that might influence the risk-benefit assessment of the IP and/or 
study device, sufficient to consider changes in product administration or overall 
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7.13.2 PRINCIPAL INVESTIGATOR (PI) RESPONSIBILITIES 
 
Forward a copy of the safety report and Investigator Safety Letter (i.e., Dear 
Investigator Letter) to their IRB/REB/EC as soon as practical in accordance with the 
governing policy and/or procedures 
 
Notify their IRB/REB/EC of safety information (i.e., SAEs, pregnancies and AESIs) that 
occur at their clinical trial site in accordance with their local institutional policy 
7.14 POST-TRIAL REPORTING REQUIREMENTS 
PIs are not obligated to actively seek AEs or SAEs beyond the clinical trial reporting period. 
However, if the PI becomes aware of an AE or SAE that occurs after the Completion or 
Termination Visit and the event is deemed by the PI to be probably or possibly related to 
the clinical trial treatment, the PI should promptly document and report the event to the 
Sponsor. Additionally, if the trial is discontinued for any reason (Section 7.15), all enrolled 
subjects still participating in the study will undergo the end of study evaluation prior to 
discontinuation from the study and any reported SAE or AESI will be followed by the PI 
until resolution or return to baseline status, or stabilization of the reported event (i.e., the 
expectation that it will remain chronic).   
7.15 CLINICAL TRIAL DISCONTINUATION  
INOVIO reserves the right to discontinue the clinical trial at this site or at multiple sites for 
safety or administrative reasons at any time. In particular, a clinical trial site that does not 
recruit at a reasonable rate may be discontinued. Additionally, the clinical trial may be 
discontinued at any time by an IRB/REB/EC, INOVIO, or a regulatory authority as part of 
their duties to ensure that clinical trial participants are protected.  
If the clinical trial is discontinued and/or the clinical trial site closed for any 
reason, all IP and devices must be returned to INOVIO or its 
representative. The PI should ensure that their site file documents are complete 
prior to archiving, and provide copies of any requested documents to INOVIO 
for its Trial Master File (TMF). 
8.0 
STATISTICAL CONSIDERATIONS 
8.1 
STATISTICAL AND ANALYTICAL PLAN 
The documentation of the statistical and analytical plan is presented below. 
8.2 
GENERAL CONSIDERATIONS 
The statistical analysis of the data will be performed by Inovio Pharmaceuticals, or its 
representative. This is a randomized across Study Group, investigator-and-participant 
blinded, placebo-controlled (SSC-0001), multi-center phase 2a trial to evaluate the safety, 
tolerability and immunological profile of INO-4700 administered in healthy adult 
volunteers.  Approximately 542 volunteers will be evaluated across two (2) parts: Part 1 
Dose Finding and Part 2 Expansion.  
Approximately 192 participants in Part 1 will be randomized across each group (A through 
I; see Table 1) to receive either INO-4700 or placebo. Upon completion of the Week 10 
visit by all Part 1 participants including evaluable immunological data from all Study 
Groups, one optimal Study Group dose and regimen will be selected for expansion into 
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Approximately 350 participants in Part 2 will be randomized to receive the optimal dose of 
INO-4700 or placebo (see Table 2). The first 225 participants randomized in parallel to 
three Study Groups will receive a third dose of either INO-4700 or placebo at Week 48. 
Participants will either receive a week 48 active treatment administration on top of their 
two prior active treatment administrations (N=100), or a week 48 placebo administration 
on top of their two prior active treatment administrations (N=100) or a week 48 placebo 
administration on top of two prior placebo administrations (N=25).  Collectively, these first 
225 participants will be followed until Week 68. The remaining 125 participants will be 
randomized in parallel to either 2 active treatment administrations (N=100) or 2 placebo 
administrations (N=25) and followed until Week 48.  
Details on the Study Group design and conduct and frequency of DMSB meetings can be 
found in Sections 3.0 and 12.1. 
The trial’s primary analyses pertains to the evaluation of the tolerability, safety and overall 
immune response to INO-4700 administered by ID injection followed by EP in healthy 
volunteers. Exploratory analyses concern the evaluation of the expanded immunological 
response to INO-4700 delivered by ID injection followed by EP. 
8.3 
STATISTICAL HYPOTHESES 
No formal statistical hypothesis will be tested in Part 1 of this trial. The hypothesis in Part 
2 of this trial is H0: p ≤ 70% versus H1: p > 70%, where p denotes the true population 
overall immunological response rate for the selected optimal dose of INO-4700. 
8.4 
ANALYTICAL POPULATIONS 
Analysis populations will be: 
The modified intention to treat (mITT) population includes all participants who receive at 
least one dose of the INO-4700 or placebo. Participants in this sample will be analyzed by 
their original assigned dose of INO-4700 or placebo. The mITT population will be used to 
analyze co-primary and exploratory immunological endpoints. 
The per-protocol (PP) population is comprised of mITT participants who receive all their 
planned administrations and who have no Medical Monitor-assessed important protocol 
violations. Analyses on the PP population will be considered supportive of the 
corresponding mITT analyses. Participants excluded from the PP population will be 
identified and documented prior to locking the study database. 
The safety analysis population includes all participants who receive at least one dose of 
INO-4700 or placebo administered by ID injection. Participants for this population will be 
grouped in accordance with the dose of INO-4700 or placebo that they received. This 
population will be used for all safety analyses in the study. 
8.5 
DESCRIPTION OF STATISTICAL METHODS 
8.5.1 
PRIMARY SAFETY ANALYSES 
The primary analyses for this trial are safety analyses of treatment emergent adverse 
events (TEAEs), administration site reactions and clinically significant changes in safety 
laboratory parameters from baseline.   
TEAEs are defined for this trial as any AEs/AESIs/SAEs that occur on or after Day 0 
following IP administration. All TEAEs will be summarized by frequency, percentage and 
associated 95% Clopper-Pearson confidence interval, and in Part 2, the difference in the 
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regimen placebo together with associated 95% confidence interval. Related SAEs and 
related Grade 3 or higher AEs will also be analyzed as described above within and 
between associated placebo in part 1. The frequencies will also be presented separately 
by dose number and will be depicted by system order class and preferred term. Additional 
frequencies will be presented with respect to maximum severity and relationship to IP. 
Multiple occurrences of the same AE in a single subject will be counted only once following 
a worst-case approach with respect to severity and relationship to IP. All serious TEAEs 
will also be summarized as above. AE duration will be calculated as AE stop date – AE 
start date + 1 day. AEs and SAEs that are not TEAEs or serious TEAEs will be presented 
in listings. 
All of these primary safety analyses will be conducted on the participants in the safety 
population. 
8.5.2 
PRIMARY IMMUNOGENICITY ANALYSES 
For both Part 1 and Part 2, antigen specific binding antibody titers, MERS-CoV neutralizing 
antibody titers, and specific cellular immune responses will be analyzed by Study Group.   
Binding antibody titer will be analyzed for each Study Group using the geometric mean 
and associated 95% confidence intervals. Percent neutralizing antibodies and antigen 
specific cellular immune response increases will be analyzed for each Study Group using 
medians, inter-quartile range and 95% confidence intervals. Percentage with overall 
immune response, inclusive of seroconversion (i.e., positive titer), and corresponding 95% 
Clopper-Pearson confidence intervals will be analyzed within each Study Group.   
In Part 1, the difference in percentage of overall immune responders including 
seroconverters between all pairs of INO-4700 Study Groups will be calculated along with 
corresponding exact 95% confidence intervals. 
In Part 2, the primary hypothesis of H0: p ≤ 70% versus H1: p > 70% will be tested with 
an exact test of a binomial proportion.  In addition, the binding antibody titer difference 
between INO-4700 and placebo will be analyzed using the geometric mean fold ratio and 
associated 95% confidence interval. Percent neutralizing antibodies and antigen specific 
cellular immune response differences between INO-4700 and placebo will be analyzed 
using the difference in medians and associated 95% confidence intervals. 
All of these primary immunogenicity analyses will be conducted on the participants in the 
mITT and PP populations. 
8.5.3 
SAFETY ANALYSES 
Laboratory response variables will be descriptively summarized in accordance with time 
point and as changes from baseline including 95% confidence intervals. Laboratory values 
considered clinically significant will be presented in listings for participants in the safety 
population. 
Measurements for vital signs as well as changes from baseline will be descriptively 
summarized by time point for participants in the safety population.   
Serum pregnancy at Screening and urine pregnancy at each post baseline time point will 
be descriptively summarized for participants in the safety population.  
The percentage of participants with abnormal medical history findings will be summarized 
by body system and preferred term for participants in the safety and mITT populations.   
For statistical analysis purposes, prior medications are defined as those that were used 
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defined as those used during the course of trial (on or after Day 0). Partial stop dates of 
prior and concomitant medications will be assumed to be the latest possible date 
consistent with the partial date. Data for all prior and concomitant medications will be 
summarized with percentages for participants in the safety and mITT populations.  
8.5.4 
DISPOSITION 
Subject disposition will be summarized for all randomized participants and will include the 
number and percentage randomized, the number and percentage who received each 
planned dose and the number who completed each part of the trial. The number and 
percentage of participants who discontinued IP in each part of the trial will be summarized 
overall and by reason. The number in each analysis population will also be presented. 
8.5.5 
DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS 
Demographic and baseline characteristic data will be descriptively summarized for 
participants in the safety and mITT populations.  
8.5.6 
INTERIM ANALYSES  
No formal interim analyses will be performed for this trial. However, safety and tolerability 
will be assessed by the DSMB as noted above for the participants in each Study Group.   
A Sponsor unblinded review of the week 10 immunogenicity and safety data will be made 
during Part 1 of this study when all evaluable data observations are available in order to 
determine the optimal dose for the Part 2 of the study. The selection of the optimal dose 
for Part 2 will involve consideration of weighted ordered criteria described in Figure 3 
below.   
Figure 3: Weighted Ordered Dose Selection Criteria 
 
At a minimum, the optimal selected dose will have a 70% overall immune response and 
acceptable safety profile as determined by the DSMB and Inovio Medical Council. Other 
criteria listed in Figure 3 will contribute to the selection of the right optimal dose if the 
overall immune responses and safety profiles are similar between the Study Groups in 
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A group-level unblinded review of the immunogenicity and safety data will be made once 
week 12 visit immunology data are complete for all participants in Part 2 whilst maintaining 
subject-level blinding. Long-term follow-up data will continue to be collected for all 
participants with remaining visits through to the final visit. These summaries and analyses 
will allow the Sponsor and collaborators to have results with respect to the immunogenicity 
endpoints corresponding to the Part 2 Week 12 visit on which to inform product 
development goals. No subject-level immunogenicity data will be produced and subject-
level immunogenicity data will not be available in the clinical trial database until all other 
clinical trial data are finalized at the end of the trial. Thus, Part 2 of the trial will remain 
blinded to the Sponsor and collaborators with respect to subject treatment assignment. 
8.5.7 
MULTIPLICITY 
No adjustment for multiplicity will be made for this trial. 
8.5.8 
MISSING VALUES 
Missing data will not be imputed or replaced, and calculations will be done on reported 
values. 
8.5.9 
EXPLORATORY ANALYSES  
T and B post baseline cell number will be analyzed descriptively by Study Group using the 
mean or median and associated 95% confidence intervals. 
In Part 2, treatment difference comparisons will include a comparison of two dose INO-
4700 participants who are boosted with INO-4700 versus two dose INO-4700 participants 
who are boosted with placebo.  
Exploratory ANCOVA and Logistic models may be fit that include baseline, confounder 
variables such as age and gender to test the relationship between study group and 
different immune response variables.  
8.6 
SAMPLE SIZE/POWER 
No formal power analysis is applicable to Part 1 of this trial, as descriptive statistics will be 
used to summarize the data. 
For each Study Group in Part 1 of the trial with 32 INO-4700 administered participants, 
the study provides 95% confidence that the true incidence of SAEs is <11% if no SAEs 
are observed in a study group. For all the Study Groups combined in Part 1 of the trial with 
160 INO-4700 administered participants, the study provides 95% confidence that the true 
incidence of SAEs is <3% if no SAEs are observed in this study phase. For all Study 
Groups combined across Parts 1 & 2 of the trial with 460 INO-4700 administered 
participants, the study provides 95% confidence that the true incidence of SAEs is <1% if 
no SAEs are observed. 
For Part 2 of this trial, an evaluable sample of 260 active subjects treated with INO-4700, 
which will be used for formal hypothesis testing, provides >90% power to detect an INO-
4700 overall immunological response rate of 70% or higher should this overall response 
rate truly be 80%, using a one-sided type 1 error rate of 0.025.  
8.7 
RANDOMIZATION AND BLINDING  
Part 1 of this study will be randomized across Study Groups (A through I). Part 2 of this 
study will be randomized between the selected optimal Active dose from Part 1 and 
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pharmacy across all Study Groups for both parts of the study. The Sponsor will be blinded 
in Part 1 until Week 10 and blinded for the entire duration of Part 2 of the study.   
For the Part 2 Week 12 analysis, group level unblinded summaries of immunogenicity and 
safety will be produced. The Sponsor will continue to remain blinded to subject-level 
treatment allocation for the remainder of the trial.    
9.0 
ETHICS 
9.1 
INVESTIGATOR AND SPONSOR RESPONSIBILITIES 
The Investigator and Sponsor are responsible for ensuring that the clinical trial is 
performed in accordance with the protocol, the principles of the Declaration of Helsinki, 
Good Clinical Practice (GCP) and applicable regulatory requirements. 
9.2 
INSTITUTIONAL REVIEW BOARD (IRB)/RESEARCH ETHICS BOARD (REB)/ETHICS 
COMMITTEE (EC) 
The Investigator will commence the clinical trial after full approval of the protocol and 
adjunctive materials (e.g., ICF, advertising) has been obtained from the applicable 
IRB/REB/EC and a copy of IRB/REB/EC approval documentation has been received by 
the Sponsor. 
Investigator responsibilities relevant to the IRB/REB/EC include the following: 
 Submit progress reports to the IRB/REB/EC as required, and request re-review 
and approval of the clinical trial at least once a year during the conduct of the 
clinical trial 
 Notify the Sponsor immediately of any suspected unexpected adverse drug or 
device events/effects 
 Notify the IRB/REB/EC immediately if the Sponsor notifies the Investigator about 
any reportable safety events 
 Obtain approval from the IRB/REB/EC for protocol amendments and for revisions 
to the consent form or participant recruitment advertisements, as required 
 Submit reports on, and reviews of, the clinical trial and its progress to the 
IRB/REB/EC at intervals stipulated in their guidelines and in accordance with 
pertinent regulations and guidelines 
 Maintain a file of clinical trial-related information (refer to clinical trial files) that 
includes all correspondence with the IRB/REB/EC 
 Notify the IRB/REB/EC when the clinical trial is completed (i.e., after the last clinical 
trial visit of the final clinical trial subject) 
 After clinical trial completion (within three [3] months is recommended), provide the 
IRB/REB/EC with a final report on the clinical trial 
Institutional Biosafety Committee (IBC), if applicable 
The Investigator will undertake the trial after full approval of the protocol and adjunctive 
materials (e.g., pharmacy manual) has been obtained from the applicable IBC and a copy 
of this approval has been received by the Sponsor. 
Investigator responsibilities relevant to the IBC include the following: 
 
Notify the Sponsor, IBC and NIH OSP within 30 days of any: 
o Substantial problems or violation of the NIH Guidelines 

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o Significant research related accidents or illnesses 
 
Notify the IBC to any changes to the research (dosage, procedure, etc.) or facility 
(new space, remodeling, etc.).   
9.3 
PROTECTION OF HUMAN PARTICIPANTS 
9.3.1 COMPLIANCE WITH INFORMED CONSENT REGULATIONS 
Written informed consent must be obtained from each subject, and/or from the subject’s 
legally authorized representative, prior to the subject’s enrollment in the clinical trial. The 
process for obtaining informed consent must be documented in the subject’s medical 
record (also refer to Section 6.2). 
9.3.2 COMPLIANCE WITH INSTITUTIONAL REVIEW BOARD (IRB)/RESEARCH ETHICS BOARD 
(REB)/ETHICS COMMITTEE (EC) REQUIREMENTS 
This clinical trial is to be conducted in accordance with applicable IRB/REB/EC 
regulations. The Investigator must obtain approval from a properly constituted 
IRB/REB/EC prior to initiating the clinical trial and obtain re-approval or review at least 
annually. The Sponsor is to be notified immediately if the responsible IRB/REB/EC has 
been disqualified or if proceedings leading to disqualification have begun. Copies of all 
IRB/REB/EC correspondence with the Investigator should be provided to the Sponsor. 
9.3.3 COMPLIANCE WITH GOOD CLINICAL PRACTICE 
This protocol is to be conducted in accordance with the applicable GCP regulations and 
guidelines. 
9.3.4 
COMPLIANCE WITH ELECTRONIC RECORDS/SIGNATURES REGULATIONS (21CFR 
PART 11) 
When applicable, this clinical trial is to be conducted in compliance with the regulations on 
electronic records and electronic signature. 
9.3.5 COMPLIANCE WITH PROTOCOL 
Participants are not required to follow special instructions specific to the IP used in this 
clinical trial. Participants will be provided with Investigator emergency contact information 
and advised to report all AEs. While every effort should be made to avoid protocol 
deviations, should an important deviation be discovered, the Sponsor must be informed 
immediately. Any protocol deviation impacting subject safety must be reported to the 
Medical Monitor immediately. 
9.3.6 CHANGES TO THE PROTOCOL 
The Investigator should not implement any deviation from, or changes to, the protocol 
without Sponsor approval and prior review and documented approval/favorable opinion of 
the protocol amendment from the IRB/REB/EC, except where necessary to eliminate 
immediate hazards to clinical trial participants, or when the changes involve only logistical 
or administrative aspects of the clinical trial (e.g., change in monitors, change of telephone 
numbers).  

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10.0 DATA COLLECTION, MONITORING AND REPORTING 
10.1 CONFIDENTIALITY AND PRIVACY 
A report of the results of this clinical trial may be published or sent to the appropriate 
regulatory authorities in any country in which the clinical trial products are legally marketed 
or may ultimately be marketed, but the subject’s name/identity will not be disclosed in 
these documents. The clinical trial Sponsor, its agents, the IRB/REB/EC and regulatory 
authorities will have direct access to the participants medical records for the purposes of 
trial-related monitoring, auditing and inspection. Appropriate precautions will be taken to 
maintain confidentiality of medical records and personal information. 
Written Authorization and other documentation are to be obtained from each subject, 
and/or from the subject’s legally authorized representative, prior to enrollment in the 
clinical trial, in accordance with all applicable laws, regulations and/or directives relating 
to privacy and data protection. 
11.0 SOURCE DOCUMENTS 
Source data is all information, electronic or hardcopy original records or clinical findings, 
laboratory results, observations, or other activities in a clinical trial necessary for the 
reconstruction and evaluation of the clinical trial. 
Examples of original source data records may include:  
 Hospital records 
 Clinical and office charts 
 Laboratory notes 
 Memoranda 
 Pharmacy dispensing records 
 Recorded data from automated instruments 
 Copies of electronic medical records (EMR) certified after verification as being 
accurate and complete 
 X-rays 
 Subject files and records kept at the pharmacy, at the laboratories, at the medical 
records facility and within information technology (IT) systems that are involved in 
the clinical trial  
The Investigator/institution will permit clinical trial-related monitoring, audits, IRB/REB/EC 
review and regulatory inspections by providing direct access to source data/documents 
related to this clinical trial. 
11.1 RECORDS RETENTION 
Upon request of the Clinical Monitor, Sponsor or its agent(s), auditor, IRB/REB/EC or 
regulatory authority, the Investigator/institution should make available for direct access all 
requested clinical trial-related records. 
CRFs will be provided for each subject. Participants must not be identified by name on 
any CRFs. Participants will be identified by their subject identification number (SID). 
It is the Investigator’s responsibility to retain clinical trial essential documents for at least 
two (2) years after the last approval of a marketing application in their country and until 
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two (2) years have elapsed since the formal discontinuation of clinical development of the 
IP. This retention period may be superseded by local requirements. The Sponsor will 
inform the Investigator/institution when these documents are no longer needed to be 
retained. 
If the Records Retention requirements are addressed in a governing clinical trial 
agreement, it is the Investigator’s responsibility to retain clinical trial essential documents 
in accordance with the governing clinical trial agreement and applicable local 
requirements. 
12.0 SAFETY AND QUALITY MONITORING 
12.1 SAFETY REVIEW 
The Sponsor’s Medical Monitor will regularly review safety and tolerability data throughout 
the trial in a blinded fashion until unblinding. Additional safety reviews will be conducted 
by a DSMB, and they will be responsible for reviewing all unblinded safety data, including 
AEs of clinical significance, AESIs and SAEs, as well as safety laboratory data. Safety 
reviews will include data from all enrolled participants. 
The DSMB is not blinded to IP allocation and will review unblinded safety data. The DSMB 
will be charged with advising whether there appears to be any safety concerns and to 
make recommendations regarding continued enrollment, trial pause and trial suspension. 
If the safety data is considered unsatisfactory during any safety review, the study may be 
paused or stopped. In this case, further enrollment and administration of INO-4700 or 
placebo to participants will be paused for further evaluation. The Sponsor will perform an 
investigation and consult the DSMB and other experts, if needed, to determine whether to 
resume randomization and/or dosing of the remainder of the participants. For further 
details see DSMB Charter.  
12.2 CLINICAL MONITORING 
Clinical Monitoring will be performed by qualified Clinical Monitors who will report to the 
Sponsor or the Sponsor’s designee. Records for all clinical trial participants in this clinical 
trial will be monitored. The following clinical trial site monitoring tasks will be performed at 
all clinical trial sites: 
 
Prior to subject screening at the site, a Site Initiation Visit will be conducted to 
review all relevant forms and documentation, and ensure that the clinical trial site 
staff are qualified and compliant with all applicable requirements 
 
All clinical trial site monitoring visits will be documented 
 
Periodic clinical trial site visits will be performed throughout the clinical trial 
 
The blinded Clinical Monitor will address and document the following trial conduct 
activities and obligations: 
o Assure that the trial is being conducted in accordance with the protocol, 
applicable regulatory agency regulations, and IRB/REB/EC policies. 
o Discuss trial conduct issues and incidents of noncompliance with the 
Investigator and/or trial personnel and document them on the resolution trip 
report. Report any significant unresolved problems immediately to the 
Sponsor. 

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o Remind the Investigator as necessary of the obligation to immediately report 
all SAE and provide subsequent follow-up report of the final outcome to the 
IRB. 
o Throughout the trial, inspect all source documents to ensure they are complete, 
logical, consistent, attributable, legible, contemporaneous, original, and 
accurate (ALCOA). 
o Assure that the trial facilities continue to be acceptable. 
o Compare the trial CRFs with source documents to assure that the data are 
accurate and complete and that the protocol is being followed. 
o Assure that investigational device accountability and reconciliation of records 
are complete and accurate. 
o Assure that all subject specimens are being stored and forwarded properly for 
testing in accordance with laboratory manual requirements. 
 
The unblinded Clinical Monitor will address and document the following trial 
conduct activities and obligations: 
o Assure that the trial is being conducted in accordance with the protocol, 
applicable regulatory agency regulations, and IRB/REB/EC policies. 
o Discuss trial conduct issues and incidents of noncompliance with the 
Investigator and/or trial personnel while maintaining the blind and document 
them on the resolution trip report. Report any significant unresolved problems 
immediately to the Sponsor while maintaining the blind. 
o Throughout the trial, inspect all source documents to ensure they are complete, 
logical, consistent, attributable, legible, contemporaneous, original, and 
accurate (ALCOA). 
o Assure that the pharmacy continues to be acceptable. 
o Assure that investigational drug accountability and reconciliation of records are 
complete and accurate. 
13.0 FINANCING AND INSURANCE 
Inovio Pharmaceuticals is the Sponsor and is fully supporting the study with funding 
provided by the Coalition for Epidemic Preparedness Innovations (CEPI). Clinical trial 
insurance has been taken out according to the laws of the countries where the study will 
be conducted. The investigative site is being compensated for the conduct of this study 
and will follow the terms described in the clinical trial agreement. This agreement was 
executed separately from this clinical trial protocol. The Investigators will be required to 
provide full financial disclosure information per 21 CFR Part 54, ICH E6 and/or local 
regulations, where applicable. 
14.0 PUBLICATION POLICY 
Publication of the results of this clinical trial in its entirety will be allowed. The proposed 
presentation, abstract and/or manuscript must be made available to the Sponsor for 
review and approval in accordance with the governing clinical trial agreement. 
 
 

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15.0 LIST OF ABBREVIATIONS 
ADE 
Adverse Device Effect 
ADR 
Adverse Drug Reaction 
AE 
Adverse Event 
AESI 
Adverse Event of Special Interest 
ALCOA 
Attributable, Legible, Contemporaneous, Original, and Accurate 
bGH polyA 
Bovine growth hormone 3’ end poly-adenylation signal 
BP 
Blood Pressure 
BUN 
Blood Urea Nitrogen 
Ca 
Calcium 
CBC 
Complete Blood Count 
CEPI 
Coalition for Epidemic Preparedness Innovations 
Cl 
Chloride 
Cr 
Creatinine 
CRF 
Case Report Form 
CS 
Clinically Significant 
DNA 
Deoxyribonucleic Acid 
DSMB 
Data Safety Monitoring Board 
EC 
Ethics Committee 
ECG 
Electrocardiogram 
EDC 
Electronic Data Capture 
EP 
Electroporation 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HBsAg 
Hepatitis B Surface Antigen 
HCO3 
Biocarbonate 
hCMV  
Human CMV 
HCV 
Hepatitis C Virus 
HIV 
Human Immunodeficiency Virus 
IB 
Investigator’s Brochure 
ICD 
Implantable-Cardioverter-defibrillator 
ICF 
Informed Consent Form 
ICH 
International Council on Harmonization 
ID 
Intradermal 
IM 
Intramuscular 
INOVIO 
Inovio Pharmaceuticals Inc. 
IP 
Investigational Product 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
K 
Potassium 
KanR 
Kanamycin resistance gene 
mITT 
modified Intent to Treat 
MM 
Medical Monitor 
MERS 
Middle East Respiratory Syndrome  
MERS-CoV 
Middle East Respiratory Syndrome Coronavirus 
mRNA 
Messenger RNA 
Na 
Sodium 
NCS 
Not Clinically Significant 
NIAID 
National Institute for Allergy and Infectious Disease 
NHP 
Non-human Primates 
PHI 
Personal Health Information 
PI 
Principal Investigator 
PII 
Personal Identifying Information 
PO4 
Potassium 

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PT 
Preferred Term 
pUC ori 
Plasmid origin of replication 
RBC 
Red blood cell 
REB 
Research Ethics Board 
RR 
Respiratory Rate 
SAE 
Serious Adverse Event 
SARS 
Severe Acute Respiratory Syndrome  
SARS-CoV 
Severe Acute Respiratory Syndrome coronavirus 
SID 
Subject Identification Number 
SOC 
System Organ Class 
SSC 
Saline Sodium Citrate 
SynCon 
Synthetic consensus 
TMF 
Trial Master File 
UADE 
Unanticipated Adverse Device Effect 
WBC 
White blood cell 
WHO 
World Health Organization 
WOCBP 
Women of Child Bearing Potential 
 
 
 

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and interferon alfa-2a for severe Middle East respiratory syndrome coronavirus infection: 
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Pascal KE, Coleman CM, Mujica AO, Kamat V, Badithe A, Fairhurst J, et al. Pre- and 
postexposure efficacy of fully human antibodies against Spike protein in a novel 
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24. 
Agrawal AS, Garron T, Tao X, Peng BH, Wakamiya M, Chan TS, et al. Generation of a 
transgenic mouse model of Middle East respiratory syndrome coronavirus infection and 
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25. 
Modjarrad K. MERS-CoV vaccine candidates in development: The current landscape. 
Vaccine 2016,34:2982-2987. 
26. 
Mubarak A, Alturaiki W, Hemida MG. Middle East Respiratory Syndrome Coronavirus 
(MERS-CoV): Infection, Immunological Response, and Vaccine Development. J Immunol 
Res 2019,2019:6491738. 
27. 
Almazan F, DeDiego ML, Sola I, Zuniga S, Nieto-Torres JL, Marquez-Jurado S, et al. 
Engineering a replication-competent, propagation-defective Middle East respiratory 
syndrome coronavirus as a vaccine candidate. MBio 2013,4:e00650-00613. 
28. 
Zhang N, Tang J, Lu L, Jiang S, Du L. Receptor-binding domain-based subunit vaccines 
against MERS-CoV. Virus Res 2015,202:151-159. 
29. 
Ma C, Li Y, Wang L, Zhao G, Tao X, Tseng CT, et al. Intranasal vaccination with 
recombinant receptor-binding domain of MERS-CoV spike protein induces much stronger 
local mucosal immune responses than subcutaneous immunization: Implication for 
designing novel mucosal MERS vaccines. Vaccine 2014,32:2100-2108. 
30. 
Modjarrad K, Roberts CC, Mills KT, Castellano AR, Paolino K, Muthumani K, et al. Safety 
and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA 
vaccine: a phase 1, open-label, single-arm, dose-escalation trial. Lancet Infect Dis 
2019,19:1013-1022. 
31. 
Muthumani K, Falzarano D, Reuschel EL, Tingey C, Flingai S, Villarreal DO, et al. A 
synthetic consensus anti-spike protein DNA vaccine induces protective immunity against 
Middle East respiratory syndrome coronavirus in nonhuman primates. Sci Transl Med 
2015,7:301ra132. 
32. 
World Health Organization. MERS Monthly Summary, April 2019. In; 2019. 
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World Health Organization. Middle East Respiratory Syndrome Coronavirus (MERS-CoV) 
Summary of Current Situation, August 2018. In; 2018. 
34. 
Cauchemez S, Fraser C, Van Kerkhove MD, Donnelly CA, Riley S, Rambaut A, et al. 
Middle East respiratory syndrome coronavirus: quantification of the extent of the epidemic, 
surveillance biases, and transmissibility. Lancet Infect Dis 2014,14:50-56. 
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37. 
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Trimble CL, Morrow MP, Kraynyak KA, Shen X, Dallas M, Yan J, et al. Safety, efficacy, 
and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human 
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Tebas P, Kraynyak KA, Patel A, Maslow JN, Morrow MP, Sylvester AJ, et al. Intradermal 
SynCon® Ebola GP DNA Vaccine is Temperature Stable and Safely Demonstrates 
Cellular and Humoral Immunogenicity Advantages in Healthy Volunteers. J Infect Dis 
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40. 
Tebas P, Roberts CC, Muthumani K, Reuschel EL, Kudchodkar SB, Zaidi FI, et al. Safety 
and Immunogenicity of an Anti-Zika Virus DNA Vaccine - Preliminary Report. N Engl J 
Med 2017. 
41. 
HVTN Full Group Meeting Washington D.C. In; 2017. 
42. 
Choe PG, Perera R, Park WB, Song KH, Bang JH, Kim ES, et al. MERS-CoV Antibody 
Responses 1 Year after Symptom Onset, South Korea, 2015. Emerg Infect Dis 
2017,23:1079-1084. 
43. 
Alshukairi AN, Khalid I, Ahmed WA, Dada AM, Bayumi DT, Malic LS, et al. Antibody 
Response and Disease Severity in Healthcare Worker MERS Survivors. Emerg Infect Dis 
2016,22. 
44. 
World Health Organization. WHO Target Product Profiles for MERS-CoV Vaccines. In: 
WHO; 2017. 
45. 
Suschak JJ, Williams JA, Schmaljohn CS. Advancements in DNA vaccine vectors, non-
mechanical delivery methods, and molecular adjuvants to increase immunogenicity. Hum 
Vaccin Immunother 2017,13:2837-2848. 
46. 
Manickan E, Karem KL, Rouse BT. DNA Vaccines - A Modern Gimmick or a Boon to 
Vaccinology? Crit Rev Immunol 2017,37:483-498. 
47. 
Porter KR, Raviprakash K. DNA Vaccine Delivery and Improved Immunogenicity. Curr 
Issues Mol Biol 2017,22:129-138. 
48. 
Li L, Petrovsky N. Molecular mechanisms for enhanced DNA vaccine immunogenicity. 
Expert Rev Vaccines 2016,15:313-329. 
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Marc MA, Dominguez-Alvarez E, Gamazo C. Nucleic acid vaccination strategies against 
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50. 
Grunwald T, Ulbert S. Improvement of DNA vaccination by adjuvants and sophisticated 
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51. 
Tregoning JS, Kinnear E. Using Plasmids as DNA Vaccines for Infectious Diseases. 
Microbiol Spectr 2014,2. 
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53. 
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Wahren B, Liu MA. DNA Vaccines: Recent Developments and the Future. Vaccines 
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Ledgerwood JE, Graham BS. DNA vaccines: a safe and efficient platform technology for 
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57. 
Martin JE, Sullivan NJ, Enama ME, Gordon IJ, Roederer M, Koup RA, et al. A DNA vaccine 
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Hirao LA, Wu L, Khan AS, Hokey DA, Yan J, Dai A, et al. Combined effects of IL-12 and 
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Rosati M, Valentin A, Jalah R, Patel V, von Gegerfelt A, Bergamaschi C, et al. Increased 
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61. 
Curcio C, Khan AS, Amici A, Spadaro M, Quaglino E, Cavallo F, et al. DNA immunization 
using constant-current electroporation affords long-term protection from autochthonous 
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Ugen KE, Kutzler MA, Marrero B, Westover J, Coppola D, Weiner DB, et al. Regression 
of subcutaneous B16 melanoma tumors after intratumoral delivery of an IL-15-expressing 
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Sarri G, Davies M, Lumsden MA, Guideline Development G. Diagnosis and management 
of menopause: summary of NICE guidance. BMJ 2015,351:h5746. 
 

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17.0 APPENDICES 
17.1 APPENDIX A: TOXICITY GRADING SCALE FOR HEALTHY ADULT AND ADOLESCENT 
VOLUNTEERS ENROLLED IN PREVENTIVE VACCINE CLINICAL TRIAL  
Table for Clinical Abnormalities 
Local Reaction to 
Injectable Product 
Mild (Grade 1) 
Moderate (Grade 
2) 
Severe (Grade 3) 
Potentially Life 
Threatening 
(Grade 4) 
Pain 
Does not interfere 
with activity 
Repeated use of 
non-narcotic pain 
reliever > 24 hours 
or interferes with 
activity 
Any use of 
narcotic pain 
reliever or 
prevents daily 
activity 
Emergency 
room (ER) visit 
or 
hospitalization 
Tenderness 
Mild discomfort to 
touch 
Discomfort with 
movement 
Significant 
discomfort at rest 
ER visit or 
hospitalization 
Erythema/Rednessa 
2.5-5 cm 
5.1-10 cm 
> 10 cm 
Necrosis or 
exfoliative 
dermatitis 
Induration/Swellingb 
2.5-5 cm and 
does not interfere 
with activity 
5.1-10 cm or 
interferes with 
activity 
> 10 cm or 
prevents daily 
activity 
Necrosis 
Vital Signsc 
Mild (Grade 1) 
Moderate (Grade 
2) 
Severe (Grade 3) 
Potentially Life 
Threatening 
(Grade 4) 
Fever   (°C)d 
            (°F)d 
38.0-38.4 
100.4-101.1 
38.5-38.9 
101.2-102.0 
39.0-40.0 
102.1-104.0 
> 40.0 
> 104.0 
Tachycardia - beats 
per minute 
101-115 
116-130 
> 130 
ER visit or 
hospitalization 
for arrhythmia 
Bradycardia - beats 
per minutee 
50-54 
45-49 
< 45 
ER visit or 
hospitalization 
for arrhythmia 
Hypertension 
(systolic) - mm Hg 
141-150 
151-155 
> 155 
ER visit or 
hospitalization 
for malignant 
hypertension 
Hypertension 
(diastolic) - mm Hg 
91-95 
96-100 
> 100 
ER visit or 
hospitalization 
for malignant 
hypertension 
Hypotension 
(systolic) - mm Hg 
85-89 
80-84 
< 80 
ER visit or 
hospitalization 
for hypotensive 
shock 
Respiratory Rate - 
breaths per minute 
17-20 
21-25 
> 25 
Intubation 
a In addition to grading the measured local reaction at the greatest single diameter, the measurement should be recorded as a 
continuous variable. 
b Induration/Swelling should be evaluated and graded using the functional scale as well as the actual measurement. 
c Subject should be at rest for all vital sign measurements. 
d Oral temperature; no recent hot or cold beverages or smoking. 
e When resting heart rate is between 60-100 beats per minute. Use clinical judgement when characterizing bradycardia among 
some healthy subject populations, for example, conditioned athletes. 
 
 

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Systemic 
(General) 
Mild (Grade 1) 
Moderate (Grade 
2) 
Severe (Grade 3) 
Potentially Life 
Threatening 
(Grade 4) 
Nausea/Vomiting 
No interference 
with activity or 1-2 
episodes/24 
hours 
Some interference 
with activity or > 2 
episodes/24 hours 
Prevents daily 
activity, requires 
outpatient IV 
hydration 
ER visit or 
hospitalization 
for hypotensive 
shock 
Diarrhea 
2-3 loose stools 
or < 400 gms/24 
hours 
4-5 loose stools or 
400-800 gms/24 
hours 
6 or more watery 
stools or > 800 
gms/24 hours or 
requires 
outpatient IV 
hydration 
ER visit or 
hospitalization 
Headache 
No interference 
with activity 
Repeated use of 
non-narcotic pain 
reliever > 24 hours 
or some 
interference with 
activity 
Significant; any 
use of narcotic 
pain reliever or 
prevents daily 
activity 
ER visit or 
hospitalization 
Fatigue 
No interference 
with activity 
Some interference 
with activity 
Significant; 
prevents daily 
activity 
ER visit or 
hospitalization 
Myalgia 
No interference 
with activity 
Some interference 
with activity 
Significant; 
prevents daily 
activity 
ER visit or 
hospitalization 
Systemic Illness 
Mild (Grade 1) 
Moderate (Grade 
2) 
Severe (Grade 3) 
Potentially Life 
Threatening 
(Grade 4) 
Illness or clinical 
adverse event (as 
defined according 
to applicable 
regulations) 
No interference 
with activity 
Some interference 
with activity not 
requiring medical 
intervention 
Prevents daily 
activity and 
requires medical 
intervention 
ER visit or 
hospitalization 
U.S. Department of Health and Human Services, Food and Drug Administration, and Center for Biologics Evaluation and 
Research. Guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive 
vaccine clinical trials. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/toxicity-grading-scale-healthy-
adult-and-adolescent-volunteers-enrolled-preventive-vaccine-clinical 2007 Sep; 3-5 
 
 

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17.2 APPENDIX B: ADVERSE EVENTS OF SPECIAL INTEREST  
For the purpose of standardization across multiple vaccine platforms, including those substantially 
different from Inovio’s platform, the below table lists adverse events of special interest (AESIs) 
relevant to MERS-CoV vaccine development.  
Body System 
AESI 
Respiratory 
Acute respiratory distress syndrome (ARDS) 
Pneumonitis/pneumonia 
Neurologic 
Generalized convulsion 
Aseptic meningitis 
Guillain-Barré Syndrome (GBS) 
Encephalopathy 
Encephalitis 
Myelitis 
Acute disseminated encephalomyelitis (ADEM) 
CNS vasculopathy (stroke) 
Hematologic 
Thrombocytopenia 
Disseminated intravascular coagulation (DIC) 
Immunologic 
Anaphylaxis 
Vasculitides 
Enhanced disease following immunization 
Other 
Local/systemic SAEs (regulatory criteria)  
Acute renal failure 
Death, including maternal death, spontaneous abortion, stillbirth and 
neonatal death 
 
 
 
 
 
 

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CONFIDENTIAL 
 
Page 1 of 75 
MERS-201 
Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for 
Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy 
Volunteers  
Sponsored by: 
Inovio Pharmaceuticals, Inc. 
Protocol Version: 2.0 
Protocol Version Date: 12Feb2021 
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Clinical Protocol 
Protocol Version Date: 12Feb2021 
CONFIDENTIAL 
Protocol Version: v2.0 
 
Page 2 of 75 
 
 
Medical Monitor Approval Page 
 
Drug:  
INO-4700 
 
Sponsor: 
Inovio Pharmaceuticals, Inc. 
 
660 W. Germantown Pike, Suite 110 
 
Plymouth Meeting, PA 19462 
 
Medical Monitor: 
, M.D., Ph.D. 
 
 
 
 
Inovio Pharmaceuticals, Inc. 
 
Approval Signature: 
 
[Electronically Signed] 
  
, MD 
 
Inovio Pharmaceuticals, Inc. 
 Date (ddMmmyyyy) 
 
 
 
 
CONFIDENTIAL 
The information in this document is considered privileged and confidential by Inovio 
Pharmaceuticals Inc. (INOVIO) and may not be disclosed to others except to the extent 
necessary to obtain Institutional Review Board (IRB)/Research Ethics Board (REB)/Ethics 
Committee (EC) approval and informed consent, or as required by local regulatory 
authorities. Persons to whom this information is disclosed must be informed that this 
information is privileged and confidential and that it should not be further disclosed 
without the written permission of INOVIO. Any supplemental information added to this 
document is also confidential and proprietary information of INOVIO and must be kept in 
confidence in the same manner as the contents of this document. 
 
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Clinical Protocol 
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Protocol Version: v2.0 
 
Page 3 of 75 
 
 
Principal Investigator Acknowledgement 
 
I have read and understood this Protocol and agree that it contains all details necessary to 
conduct the clinical trial. I understand that it must be reviewed by the Institutional Review Board 
(IRB)/Research Ethics Board (REB)/Ethics Committee (EC) overseeing the conduct of the 
clinical trial and approved or given favorable opinion before implementation. 
 
The Principal Investigator’s (PI’s) signature constitutes the PI’s approval of this Protocol and 
provides the necessary assurances that this clinical trial will be conducted in accordance with 
International Council for Harmonization (ICH)/Good Clinical Practice (GCP), local legal and 
regulatory requirements, and all stipulations of the Protocol. 
 
 
Principal Investigator Signature: 
 
 
 
 
Principal Investigator Printed Name 
 
 
 
 
 
Principal Investigator Signature 
 
Date (ddMmmyyyy) 
 
 
 
Clinical Trial Site Number: 
 
Clinical Trial Site Name: 
 
 
 
 
 
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Clinical Protocol 
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Protocol Version: v2.0 
 
Page 4 of 75 
 
SUMMARY OF CHANGES 
The following is a list of significant protocol changes from v1.0 23Mar2020 to v2.0 12FEB2021. 
All other changes are administrative and do not significantly affect the safety of subjects, trial 
scope, or scientific quality of the protocol. 
 
1. Exclusion Criteria and Restrictions related to receipt of other vaccinations have been updated 
due to anticipated availability of the COVID-19 vaccine.  Previously, participants were not to 
receive other vaccinations within 2 weeks before or after dosing.  This has been amended to 
prohibit receipt of  other vaccinations from 30 days prior to Day 0 until completion of the study 
visit occurring 2 weeks after the second dose of investigational product (i.e. the Week 6 visit 
if dosed at Week 4 and the Week 10 visit if dosed at Week 8).  For Part 2B, receipt of other 
vaccinations is also prohibited from 2 weeks prior to the Week 48 visit through the Week 50 
visit. 
2. Exclusion criteria has been updated to no longer prohibit prior receipt of an investigational 
vaccine product for SARS. 
3. The collection of adverse events has been updated so that all adverse events will be collected 
throughout the study, rather than only collecting related adverse events, adverse events of 
special interest and serious adverse events subsequent to the Week 12 visit.  This will allow 
for improved safety assessment after the Part 2, Week 48 booster dose.   
4. The timeline for contraception requirements has been updated so that contraception must be 
used from screening until 3 months following last dose, rather than from screening to 1 month 
following last dose, for consistency across the Sponsor’s infectious disease programs.  
Exclusion criteria a was also updated accordingly. 
5. At the Principal Investigator’s discretion, collection of the screening immunology samples may 
be postponed and collected along with the Day 0 samples. This may decrease the 
unnecessary collection of immunology samples from participants that fail screening.  
6. The following changes have been made to the visit procedures: 
a. Week 2, Part 1 and Part 2: Collection of immunology samples has been removed.  
Based on experience across DNA vaccine studies, the week 2 sample is not 
needed to adequately assess immune response. 
b. Week 12, Part 1 and Part 2 (Day 0 & Week 8): Collection of immunology samples 
has been removed.  Based on experience across DNA vaccine studies, the week 
2 sample is not needed to adequately assess immune response.  These visits have 
been updated to follow-up phone calls for collection of adverse events.  
c. Week 8, Part 2 (Day 0 & Week 8): Collection of immunology samples has been 
added.  This will allow for better assessment of immune response after one dose. 
7. Applicable footnotes for Tables 4, 5 and 6 have been updated to reflect whole blood collection 
in 4 x 8.0 mL (32 mL) Cell Preparation Tubes (CPT) rather than 4 x 8.5 mL (34 mL) Acid 
Citrate Dextrose (ACD) tubes.  A total of 64 mL will be collected prior to first dose, rather than 
68 mL. 
8. The Exploratory Objectives, Exploratory Endpoints and Statistical Analysis Plan have been 
updated to include evaluation of humoral immune response of MERS-CoV spike protein and 
cross reactivity to other coronavirus spike proteins.   
9. Total blood collection volume has been updated to reflect current standard volumes and the 
switch from ACD to CPT tubes.  
10. A statement clarifying that participants who discontinue or withdraw from the study will not be 
replaced, has been added. 
11. Examples of the Investigational Product vial and carton labels have been added. 
12. The SAE reporting contact information has been updated. 
13. The Medical Monitor contact information has been updated. 
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14. A statement indicating investigators will request follow-up from pregnant participants or 
pregnant partners 30 days after the end of pregnancy, has been added. 
15. COVID-19 was added as an Adverse Event of Special Interest. 
16. Statements clarifying that all pregnancy and safety information will be entered into the 
Sponsor’s safety database have been added. 
17. A statement that eSource will be utilized in this study has been added. 
18. A statement was added to Section 8.4.6 to clarify how the blind will be protected if the number 
of subjects who experience an event is greater than 0 and the count of these events relative 
to the total count of events produces a percentage less than 3% for a given analysis. 
19. Section 7.8.1.1 was added to clarify management of COVID-19 infection and vaccination. 
20. It was clarified that bicarbonate results can be HCO3 or CO2. 
21. It was clarified that SSC-0001 may be packaged at a volume of 1.1 mL in 2 mL vials, in addition 
to 2.0 mL in 10 mL vials, as any future lots of SSC-0001 may be packaged as such. 
 
 
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Table of Contents 
Summary of Changes ................................................................................................................ 4 
Clinical Protocol Synopsis .........................................................................................................11 
Figure 1 – Study Design and Dosing Schema ...........................................................................17 
Table 4 – Part 1 Trial Schedule of Events .................................................................................18 
Table 5 – Part 2 Trial Schedule of Events (Day 0 & Week 4 Optimal Regimen) ........................19 
Table 6 – Part 2 Trial Schedule of Events (Day 0 & Week 8 Optimal Regimen) ........................20 
1.0 
Introduction .................................................................................................................21 
1.1 
Background and Scientific Rationale ........................................................................... 21 
1.2 
Background Information .............................................................................................. 21 
1.2.1 
Clinical Presentation and Immune Response ........................................................21 
1.2.2 
Current Treatment and Unmet Need .....................................................................22 
1.2.3 
Emerging Health Threat ........................................................................................23 
1.3 
Rationale .................................................................................................................... 23 
1.3.1 
Dose and Regimen Rationale ...............................................................................23 
1.3.2 
DNA Vaccines.......................................................................................................25 
1.3.3 
Use of Electroporation with DNA Vaccines ...........................................................25 
1.4 
Potential Benefits and Risks ....................................................................................... 26 
2.0 
Objectives and Purpose ..............................................................................................27 
2.1 
Hypothesis .................................................................................................................. 27 
3.0 
Clinical Trial Design and Endpoints ............................................................................27 
3.1 
Primary Objectives ...................................................................................................... 29 
3.2 
Primary Endpoints....................................................................................................... 29 
3.3 
Exploratory Objective .................................................................................................. 29 
3.4 
Exploratory Endpoint ................................................................................................... 29 
3.5 
Safety Assessment ..................................................................................................... 29 
3.6 
Immunogenicity Assessment ...................................................................................... 30 
4.0 
Clinical Trial Population ..............................................................................................30 
4.1 
Inclusion Criteria ......................................................................................................... 30 
4.2 
Exclusion Criteria ........................................................................................................ 31 
4.3 
Discontinuation/Withdrawal of Clinical Trial Participants ............................................. 31 
5.0 
Clinical Trial Treatment ...............................................................................................32 
5.1 
Investigational Products (IPs) and Study Device ......................................................... 32 
5.1.1 
INO-4700 and SSC-0001 ......................................................................................32 
5.1.2 
CELLECTRATM 2000 ............................................................................................33 
5.2 
Treatment Regimens .................................................................................................. 33 
5.2.1 
Blinding .................................................................................................................34 
5.3 
Packaging and Labeling .............................................................................................. 34 
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5.3.1 
INO-4700 / SSC-0001 ...........................................................................................34 
5.3.2 
CELLECTRATM 2000 ............................................................................................35 
5.4 
Handling and Storage ................................................................................................. 35 
5.4.1 
INO-4700 and SSC-0001 ......................................................................................35 
5.4.2 
CELLECTRATM 2000 ............................................................................................35 
5.5 
Preparation and Dispensing ........................................................................................ 36 
5.6 
Use of Study Device ................................................................................................... 36 
5.7 
Investigational Drug and Study Device Accountability ................................................. 36 
5.7.1 
INO-4700 and SSC-0001 Accountability ...............................................................36 
5.7.2 
CELLECTRATM 2000 Accountability ......................................................................36 
5.8 
Return and Destruction of Investigational Drug and Study Device .............................. 36 
5.8.1 
INO-4700 and SSC-0001 ......................................................................................36 
5.8.2 
Return of CELLECTRATM 2000 .............................................................................37 
6.0 
Clinical Trial Procedures and Schedule ......................................................................37 
6.1 
Procedure by Visit ....................................................................................................... 37 
6.1.1 
Clinical Trial Screening Evaluations ......................................................................37 
6.1.1.1 Medical History .....................................................................................................38 
6.1.2 
Clinical Trial Evaluations and Procedures .............................................................38 
6.1.2.1 Day 0 ....................................................................................................................39 
6.1.2.2 Week 2 .................................................................................................................39 
6.1.2.3 Week 4 .................................................................................................................39 
6.1.2.4 Week 6 .................................................................................................................40 
6.1.2.5 Week 8 .................................................................................................................40 
6.1.2.6 Week 10 ...............................................................................................................41 
6.1.2.7 Week 12 ...............................................................................................................42 
6.1.2.8 Week 30 ...............................................................................................................42 
6.1.2.9 Week 48 ...............................................................................................................42 
6.1.2.10 Week 50 ...............................................................................................................43 
6.1.2.11 Week 68 ...............................................................................................................43 
6.2 
Informed Consent ....................................................................................................... 44 
6.3 
Assignment of Subject Identification Numbers ............................................................ 44 
6.4 
Safety Evaluations ...................................................................................................... 44 
Physical Exam and Targeted Physical Assessments .........................................................44 
Vital Signs ..........................................................................................................................44 
Height and Weight .............................................................................................................45 
12-lead ECG ......................................................................................................................45 
Laboratory Evaluations ......................................................................................................45 
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6.4.1 
Injection and EP ....................................................................................................46 
6.4.2 
Management of Anxiety and Pain Due to Electroporation (EP) Procedures ..........46 
6.4.3 
Assessment of Laboratory Abnormalities ..............................................................46 
6.4.4 
Assessment of Clinical Trial Adverse Events (AEs) ..............................................47 
6.4.5 
Assessment of Injection Site Reactions ................................................................47 
6.4.6 
Peripheral Blood Immunogenicity Assessments ....................................................48 
6.4.7 
Concomitant Medications/Treatments ...................................................................48 
6.4.8 
Restrictions ...........................................................................................................48 
7.0 
Evaluation of Safety and Management of Toxicity ......................................................49 
7.1 
Safety Parameters ...................................................................................................... 49 
7.2 
Adverse Events (AEs) ................................................................................................. 49 
7.3 
Adverse Drug Reaction (ADR) .................................................................................... 49 
7.4 
Serious Adverse Events (SAEs) .................................................................................. 49 
7.5 
Unexpected Adverse Drug Reaction ........................................................................... 50 
7.6 
Unanticipated (Serious) Adverse Device Effect (UADE) .............................................. 50 
7.7 
Device Deficiency ....................................................................................................... 51 
7.8 
Safety and Toxicity Management ................................................................................ 51 
7.8.1 
Adverse Event of Special Interest (AESI) ..............................................................51 
7.8.1.1 Management of COVID-19 Infection and COVID-19 Immunization .......................51 
7.8.2 
Abnormal Laboratory Value ..................................................................................52 
7.8.3 
Clinical Trial Stopping Rules .................................................................................52 
7.9 
Safety Data Reporting Period, Method of Collection and Submission ......................... 52 
7.10 
Adverse Event Reporting ............................................................................................ 53 
7.10.1 Submitting the Initial Serious Adverse Event (SAE) Report Form..........................53 
7.10.2 Recording the Event .............................................................................................54 
7.10.3 Assessing Severity (Intensity) ...............................................................................54 
7.10.4 Causal Relationship of Clinical Material to Adverse Events (AEs) .........................54 
7.11 
Reporting Pregnancy During the Clinical Trial ............................................................. 55 
7.12 
Reporting Device-Related Complaints or Deficiencies ................................................ 56 
7.13 
Notifying Regulatory Authorities and Institutional Review Boards (IRBs)/Research 
Ethics Boards (REBs)/Ethics Committees (ECs) of Safety Information ....................... 56 
7.13.1 Sponsor Responsibilities .......................................................................................56 
7.13.2 Principal Investigator (PI) Responsibilities ............................................................56 
7.14 
Post-Trial Reporting Requirements ............................................................................. 56 
7.15 
Clinical Trial Discontinuation ....................................................................................... 57 
8.0 
Statistical Considerations ...........................................................................................57 
8.1 
Statistical and Analytical Plan ..................................................................................... 57 
8.2 
General Considerations .............................................................................................. 57 
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8.3 
Statistical Hypotheses ................................................................................................. 58 
8.4 
Analytical Populations ................................................................................................. 58 
8.5 
Description of Statistical Methods ............................................................................... 58 
8.5.1 
Primary Safety Analyses .......................................................................................58 
8.5.2 
Primary Immunogenicity Analyses ........................................................................58 
8.5.3 
Safety Analyses ....................................................................................................59 
8.5.4 
Disposition ............................................................................................................59 
8.5.5 
Demographic and Other Baseline Characteristics .................................................59 
8.5.6 
Interim Analyses ...................................................................................................60 
8.5.7 
Multiplicity .............................................................................................................61 
8.5.8 
Missing Values......................................................................................................61 
8.5.9 
Exploratory Analyses ............................................................................................61 
8.6 
Sample Size/Power ..................................................................................................... 61 
8.7 
Randomization and Blinding ....................................................................................... 61 
9.0 
Ethics .........................................................................................................................62 
9.1 
Investigator and Sponsor Responsibilities ................................................................... 62 
9.2 
Institutional Review Board (IRB)/Research Ethics Board (REB)/Ethics Committee (EC)
 ................................................................................................................................... 62 
9.3 
Protection of Human Participants ................................................................................ 63 
9.3.1 
Compliance with Informed Consent Regulations ...................................................63 
9.3.2 
Compliance with Institutional Review Board (IRB)/Research Ethics Board 
(REB)/Ethics Committee (EC) Requirements ........................................................63 
9.3.3 
Compliance with Good Clinical Practice ................................................................63 
9.3.4 
Compliance with Electronic Records/Signatures Regulations (21CFR Part 11) .....63 
9.3.5 
Compliance with Protocol .....................................................................................63 
9.3.6 
Changes to the Protocol .......................................................................................63 
10.0 
Data Collection, Monitoring and Reporting ..................................................................63 
10.1 
Confidentiality and Privacy .......................................................................................... 63 
11.0 
Source Documents .....................................................................................................64 
11.1 
Records Retention ...................................................................................................... 64 
12.0 
Safety and Quality Monitoring .....................................................................................65 
12.1 
Safety Review ............................................................................................................. 65 
12.2 
Clinical Monitoring....................................................................................................... 65 
13.0 
Financing and Insurance ............................................................................................66 
14.0 
Publication Policy .......................................................................................................66 
15.0 
List of Abbreviations ...................................................................................................67 
16.0 
References .................................................................................................................69 
17.0 
Appendices .................................................................................................................73 
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17.1 
APPENDIX A: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers 
Enrolled in Preventive Vaccine Clinical Trial ............................................................... 73 
17.2 
APPENDIX B: Adverse Events of Special Interest ...................................................... 75 
 
 
 
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CLINICAL PROTOCOL SYNOPSIS 
Protocol Title: Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for 
Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers 
Protocol Number: MERS-201 
Clinical Trial Phase: 2a 
Estimated Number of Clinical Trial Centers and Countries/Regions: Approximately nine 
(9) to ten (10) centers in the Middle East and Africa Regions. Additional sites and countries 
may be added as necessary.   
Clinical Trial Design:  
This is a Phase 2a, randomized, blinded, placebo-controlled, multi-center trial to evaluate the 
safety, tolerability and immunological profile of INO-4700 administered by intradermal (ID) 
injection followed by electroporation (EP) using the CELLECTRATM 2000 device in healthy adult 
volunteers. The primary objectives of this trial are to evaluate the tolerability, safety and 
immunogenicity of INO-4700 administered by ID injection followed by EP in healthy adult 
volunteers according to the regimens outlined in Table 1, Table 2, Table 3 and Figure 1.  
Approximately 542 healthy volunteers will be evaluated across two (2) parts of this study, Part 
1 and Part 2. INO-4700 or placebo (SSC-0001) will be administered ID in ~0.1 mL dose volume 
followed immediately by EP. 
Part 1 – Dose Finding 
In Part 1, approximately 192 participants ages 18-50 years will be assessed through five (5) 
dose levels and regimens. These five (5) dose levels and regimens will be evaluated across 
nine (9) groups designated Study Groups A, B, C, D, E, F, G, H and I. Study Groups A, B, C, 
D and E will receive INO-4700 and enroll approximately 32 participants per group. Study 
Groups F, G, H and I will receive placebo and enroll approximately 8 participants per group. 
 
Table 1: MERS-201 Part 1 Dose Groups 
 
Study 
Group 
Number of 
Participants 
Dosing 
Weeks 
Number of  
Injections + EP 
per Dosing Visit 
INO-4700 (mg) 
per injection 
Total Dose of 
INO-4700 (mg) 
Active 
A 
32 
0, 4 
1 
0.6 
1.2 
B 
32 
0, 4 
1 
1.0 
2.0 
C 
32 
0, 8 
1 
1.0 
2.0 
D 
32 
0, 8 
2a 
0.5 + 0.5 (1.0) 
2.0 
E 
32 
0, 4 
2a 
1.0 + 1.0 (2.0) 
4.0 
Total Active 
160 
 
 
 
 
Placebo 
F 
8 
0, 4 
1 
─ 
─ 
G 
8 
0, 8 
1 
─ 
─ 
H 
8 
0, 8 
2a 
─ 
─ 
I 
8 
0, 4 
2a 
─ 
─ 
Total Placebo 
32 
 
Total 
192 
 
aINO-4700 will be injected ID followed by EP in an acceptable location on two different limbs at each dosing visit 
 
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Participants will be randomized to receive either INO-4700 or placebo according to the dosing 
schedule described in Table 1. All participants and all clinical site staff will remain blinded to 
the subject treatment allocation (i.e., INO-4700 or placebo) within each Study Group, with the 
exception of the site’s pharmacy personnel.  
Enrollment into all Study Groups will proceed in parallel. After the first four (4) participants in 
Active Study Groups and the first two (2) participants in Placebo Study Groups have Week 2 
clinical laboratory and adverse event data available, the results will be reviewed by the Data 
Safety and Monitoring Board (DSMB) (Figure 1). Enrollment will not be paused during this 
DSMB review, and screening and randomization may continue.  
Upon completion of the Week 10 visit and availability of immunological data, Part 1 will be 
unblinded in order to allow for one regimen to be selected for advancement into Part 2. The 
Study Group with an optimal immune response, an acceptable safety profile and tolerant dosing 
regimen by Week 10, will be selected for Part 2. The Sponsor will remain blinded through Part 
1 of the study until initiation of the Week 10 data review.  
All Part 1 participants will be followed for 48 weeks from the Day 0 dosing [i.e., Week 48 will be 
the planned End of Study (EOS) visit]. 
Part 2 – Expansion   
In Part 2, approximately 350 participants will be evaluated across one (1) dose level and 
regimen as outlined in Table 2 and Table 3. The dose level and regimen will be identified based 
on the optimal dose selection from Part 1. Enrollment into Part 2 may begin following completion 
of the Week 10 optimal dose and regimen selection in Part 1 (i.e., prior to Week 48 completion 
in Part 1).  
 
Table 2: MERS-201 Part 2A Dose Groups 
Study Group 
Number of 
Participants 
Dosing Weeks 
Dose and 
Regimen 
Active  
300 
0, 4 or 8 
TBD 
Placebo 
50 
0, 4 or 8 
TBD 
Total 
350 
 
 
 
Table 3: MERS-201 Part 2B Dose Groups 
Study Group 
Number of 
Participants 
Dosing Week 
Dose and 
Regimen 
Active – Booster  
100a 
48 
TBD 
Active – Placebo 
100b 
48 
TBD 
Placebo 
25c 
48 
TBD 
Total 
225 
 
 
aFirst (Day 0), second (Week 4 or 8) and third (Week 48 booster) doses will be INO-4700.  
bFirst (Day 0) and second (Week 4 or 8) doses will be INO-4700. Third dose will be a placebo dose at Week 48. 
cPlacebos will also receive a third dose in order to maintain blinded design. First (Day 0), second (Week 4 or 8) and third (Week 
48) doses will be a placebo dose. 
TBD, to be determined based on Part 1 optimal dose and regimen selection 
In Part 2A, participants will be randomized to receive the optimal dose of active (INO-4700) 
selected in Part 1 of this study or placebo (SSC-0001) (Figure 1). Approximately 300 
participants will receive INO-4700 and 50 participants will receive placebo.  
In Part 2B, the first 200 participants randomized to the Part 2A Active Study Group will receive 
a third dose of either INO-4700 or placebo at Week 48. Specifically, Study Group “Active – 
Booster” will receive INO-4700 at the first (Day 0), second (Week 4 or 8) and third (booster at 
Week 48) doses. Study Group “Active – Placebo” will receive INO-4700 at the first (Day 0) and 
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second (Week 4 or 8) doses, and placebo at the third (Week 48) dose. Similarly, in Part 2B, the 
first 25 participants randomized to the Part 2A Placebo Study Group will receive a third dose of 
placebo at Week 48. Collectively, these first 225 participants will be followed for 68 weeks from 
the Day 0 dosing [i.e., Week 68 will be the planned End of Study (EOS) visit]. All remaining 125 
participants in Part 2A (i.e., those receiving only 2 doses) will be followed for 48 weeks from 
the Day 0 dosing [i.e., Week 48 will be the planned End of Study (EOS) visit].  
All participants and all clinical site staff will remain blinded to the subject treatment allocation 
(i.e., INO-4700 or placebo), with the exception of the site’s pharmacy personnel. Enrollment 
into Active and Placebo Study Groups will proceed in parallel. No enrollment pauses are 
planned. 
Upon completion of the Week 12 visit and availability of immunological and safety data, group-
level (INO-4700 or placebo) unblinded summaries of immunogenicity and safety will be 
produced. This Week 12 analysis will serve to inform product development goals. The Sponsor 
will continue to remain blinded to subject-level treatment allocation (i.e., INO-4700 or placebo) 
for the remainder of the trial. 
DSMB for Parts 1 and 2 
The DSMB will remain unblinded throughout the duration of the study.  
In Part 1, the DSMB will review clinical laboratory and adverse event data for the first six (6) 
participants, 4 active and 2 placebos, in each Active and Placebo Study Group, respectively, 
after the Week 2 safety data are complete. The DSMB will again convene to review all available 
safety data for all Study Groups after approximately 50% of planned participants are enrolled 
(i.e., approximately 96 participants), and once enrollment is complete.  
Subsequently, the DSMB will convene approximately every three (3) calendar months 
thereafter until study completion. Enrollment pauses are not planned during any DSMB review 
in Part 1 nor 2. 
Should the criteria for any stopping rule be met, at any time, the DSMB will be notified, and the 
study may be paused or stopped if the DSMB considers the safety data unsatisfactory. In this 
case, further enrollment and administration of INO-4700 or placebo to participants will be 
paused for further evaluation. The Sponsor will perform an investigation and consult the DSMB 
and other experts, if needed, to determine whether to resume randomization and/or dosing of 
the remainder of the participants to the study or Study Group(s).  
Criteria for Evaluation:  
Research Hypothesis: 
• 
A selected optimal dose of INO-4700 delivered ID followed by EP using CELLECTRATM 
2000 in healthy volunteers will be well tolerated, exhibit an acceptable safety profile 
and result in generation of immune responses to MERS-CoV.  
Primary Objectives: 
• 
Evaluate the tolerability and safety of INO-4700 administered by ID injection followed 
by EP in healthy adult volunteers 
• 
Evaluate the cellular (T cell) and humoral immune response to INO-4700 administered 
by ID injection followed by EP for identification and confirmation of an optimal dose and 
regimen  
• 
Evaluate selected optimal dose for safety and immunogenicity  
Primary Safety Endpoints: 
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• 
Incidence of adverse events by system organ class (SOC), preferred term (PT), 
severity and relationship to investigational product  
• 
Administration (i.e., injection) site reactions (described by frequency and severity)  
• 
Incidence of adverse events of special interest  
Primary Immunogenicity Endpoints: 
• 
Overall immune response 
o MERS-CoV antigen specific antibodies  
o Antigen specific cytokine-producing T cell responses  
Exploratory Objective:  
• 
Evaluate the expanded immunological profile by assessing both T and B cell immune 
responses 
• 
Evaluate the cellular (T cell) and humoral immune response to INO-4700 administered 
by ID injection followed by EP for impact of boosting with a third dose 
• 
Evaluate humoral immune response cross reactivity to other coronaviruses 
Exploratory Endpoint:  
• 
Expanded immunological profile which may include (but not limited to) additional 
assessment of T and B cell numbers and T and B cell molecular changes by measuring 
immunologic proteins and mRNA levels of genes of interest at all weeks as determined 
by sample availability 
• 
Antibodies to other coronaviruses  
 
Safety Assessment: 
For Part 1, adverse events will be collected at every visit and safety samples will be drawn at 
Screening, Week 2, Week 6, Week 10 and Week 48. For Part 2, adverse events will be 
collected at every visit and safety samples will be drawn at Screening, Week 2, Week 6 (if 
optimal regimen includes dosing at Week 4), Week 10 (if optimal regimen includes dosing at 
Week 8), Week 48, Week 50 (for Part 2B participants receiving three doses) and Week 68 
(for Part 2B participants receiving three doses). Refer to the Schedule of Events Table 4, 
Table 5 and Table 6 for additional details. 
For both Parts 1 and 2, all adverse events, regardless of relationship, will be collected from 
the time of consent until study discharge. 
Additionally, for both Parts 1 and 2, a pregnancy test will be performed at screening and prior 
to each dose. 
Immunogenicity Assessment:  
For Part 1, immunology blood samples will be collected at Screening, Day 0, Week 6, Week 
10 and Week 48. For Part 2, immunology blood samples will be collected at Screening, Day 
0, Week 6 (if optimal regimen includes dosing at Week 4), Week 8 (if optimal regimen includes 
dosing at Week 8), Week 10 (if optimal regimen includes dosing at Week 8), Week 12 (if 
optimal regimen includes dosing at Week 4), Week 48, Week 50 (for Part 2B participants 
receiving three doses) and Week 68 (for Part 2B participants receiving three doses). Refer to 
the Schedule of Events Table 4, Table 5 and Table 6 for additional details. Determination of 
analysis of collected samples for immunological endpoints will be determined on an ongoing 
basis throughout the study. 
Clinical Trial Population: 
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Clinical Protocol 
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Protocol Version: v2.0 
 
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Part 1 – Healthy adult volunteers between the ages of 18-50 years, inclusive.  
Part 2 – Healthy adult volunteers at least 18 years of age. 
Inclusion Criteria: 
a. Able to provide informed consent and have signed Informed Consent Form (ICF) prior 
to screening procedures; 
b. For Part 1, adults age 18 and 50 years, inclusive. For Part 2, adults at least 18 years 
of age; 
c. Judged to be healthy by the Investigator on the basis of medical history, physical 
examination and vital signs performed at Screening; Note: Participants taking daily 
prescription or non-prescription medications for management of acceptable chronic 
medical conditions must be on a stable dose, as defined by non-change in dose for the 
3 months prior to the first dose of study medication and no planned changes during the 
active dosing period of the study; 
d. Able and willing to comply with all study procedures; 
e. Screening laboratory results within normal limits for testing laboratory or deemed not 
clinically significant by the Investigator; 
f. Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody 
and Human Immunodeficiency Virus (HIV) antibody or rapid test at screening; 
g. Screening ECG deemed by the Investigator as having no clinically significant findings 
(e.g. Wolff-Parkinson-White syndrome); 
h. Must meet one of the following criteria with respect to reproductive capacity: 
• 
Women who are post-menopausal as defined by spontaneous amenorrhea for 
≥ 12 months; 
• 
Surgically sterile or have a partner who is sterile (i.e., vasectomy in males at 
least six (6) months prior to enrollment or tubal ligation, absence of ovaries 
and/or uterus in females); 
• 
Use of medically effective contraception with a failure rate of < 1% per year 
when used consistently and correctly from screening until 3 months following 
last dose. Acceptable methods include:  
‒ 
hormonal contraception including implants, injections or oral; 
‒ 
two barrier methods, e.g., condom and cervical cap (with spermicide) or 
diaphragm (with spermicide); 
‒ 
abstinence when this is the subject’s preferred and usual lifestyle. Note: 
Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-
ovulation methods) and withdrawal are not acceptable methods of 
contraception. 
Exclusion Criteria: 
a. Pregnant or breastfeeding, or intending to become pregnant or father children within 
the projected duration of the trial starting with the screening visit until 3 months following 
last dose; 
b. Positive serum pregnancy test during screening or positive urine pregnancy test prior 
to dosing; 
c. History of respiratory diseases such as asthma, chronic obstructive pulmonary disease 
or chronic bronchitis; 
d. Is currently participating in or has participated in a study with an investigational product 
within 30 days preceding Day 0; 
e. Previous receipt of any vaccine within 30 days preceding Day 0 or planning to receive 
any vaccine during the timeframe restricted per the protocol; 
f. Previous receipt of an investigational vaccine product for prevention of MERS; 
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Clinical Protocol 
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g. Prior exposure to MERS-CoV or camels (serology or antibody testing will be requested 
at the Investigator’s discretion); 
h. Participants who participated in MERS-201 Part 1 cannot participate in MERS-201 Part 
2; 
i. 
Fewer than two acceptable sites available for ID injection and EP considering the 
deltoid and anterolateral quadriceps muscles. The following are unacceptable sites: 
a. Tattoos, keloids or hypertrophic scars located within 2 cm of intended 
administration site; 
b. Implantable-Cardioverter-defibrillator (ICD) or pacemaker (to prevent a life-
threatening arrhythmia) that is located ipsilateral to the deltoid injection site 
(unless deemed acceptable by a cardiologist); 
c. Any metal implants or implantable medical device within the electroporation 
site; 
j. 
Prisoner or participants who are compulsorily detained (involuntary incarceration); 
k. Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, 
topical skin and/or eye drop-containing corticosteroids) prior to dosing. Systemic 
corticosteroids must be discontinued at least 3 months prior to first dose;  
l. 
Reported active drug or alcohol or substance abuse or dependence. 
Clinical Trial Treatment: 
• 
Part 1 Group A – One 0.6 mg ID injection of INO-4700 followed by EP administered 
at Day 0 and Week 4 (± 5 days) 
• 
Part 1 Group B – One 1.0 mg ID injection of INO-4700 followed by EP administered 
at Day 0 and Week 4 (± 5 days) 
• 
Part 1 Group C – One 1.0 mg ID injection of INO-4700 followed by EP administered 
at Day 0 and Week 8 (± 5 days) 
• 
Part 1 Group D – Two 0.5 mg ID injections (in an acceptable location on two 
different limbs) of INO-4700 followed by EP administered at Day 0 and Week 8 (± 
5 days) 
• 
Part 1 Group E – Two 1.0 mg ID injections (in an acceptable location on two different 
limbs) of INO-4700 followed by EP administered at Day 0 and Week 4 (± 5 days) 
• 
Part 1 Group F – One ID injection of placebo followed by EP administered at Day 0 
and Week 4 (± 5 days) 
• 
Part 1 Group G – One ID injection of placebo followed by EP administered at Day 
0 and Week 8 (± 5 days) 
• 
Part 1 Group H – Two ID injections (in an acceptable location on two different limbs) 
of placebo followed by EP administered at Day 0 and Week 8 (± 5 days) 
• 
Part 1 Group I – Two ID injections (in an acceptable location on two different limbs) 
of placebo followed by EP administered at Day 0 and Week 4 (± 5 days) 
• 
Part 2 – Dose and regimen to be determined, each ID injection(s) followed by EP 
administered at Day 0, Week 4 or Week 8, and Week 48 (for Part 2B participants 
receiving a third dose) 
 
INO-4700 or placebo will be administered intradermally in ~0.1 mL dose volume followed 
immediately by EP. 
Formulation: 
INO-4700 in sodium chloride and sodium citrate, refrigerated. Placebo [sterile saline sodium 
citrate buffer (SSC-0001)], refrigerated. 
 
 
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Clinical Protocol 
Protocol Version Date: 12Feb2021 
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Protocol Version: v2.0 
 
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FIGURE 1 – STUDY DESIGN AND DOSING SCHEMA 
 
 
 
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Page 18 of 75 
 
TABLE 4 – PART 1 TRIAL SCHEDULE OF EVENTS 
Tests and assessments 
Screena 
Day 0 
Week 2 
(± 3d) 
Week 4 
(± 5d) 
Week 6 
(± 5d) 
Week 8 
(± 5d) 
Week 10 
(± 5d) 
Week 12b 
(± 5d) 
Week 30b 
(± 10d) 
 
Week 48 
(± 5d) 
 
Pre 
Post 
Pre 
Post 
Pre 
Post 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Medical History 
X 
Xa 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Concomitant Medications 
X 
X 
 
X 
X 
 
X 
X 
 
X 
 
 
X 
Physical Examc 
X 
X 
 
X 
X 
 
X 
X 
 
X 
 
 
X 
Vital Signs 
X 
X 
 
X 
X 
 
X 
X 
 
X 
 
 
X 
Height and Weight 
X 
 
 
 
 
 
 
 
 
 
 
 
 
CBC with Differential 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Chemistry and Liver Functiond 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Serologye 
X 
 
 
 
 
 
 
 
 
 
 
 
 
12-lead ECG 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Urinalysis Routinef 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Pregnancy Testg 
X 
X 
 
 
Xk 
 
 
Xl 
 
 
 
 
 
INO-4700 or placebo + EPh 
 
Xi,j 
 
 
Xi,k 
 
 
Xj,l 
 
 
 
 
 
Download EP Datam 
 
 
X 
 
 
Xk 
 
 
Xl 
 
 
 
 
Adverse Eventsn 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Immunology (Whole blood)o 
X 
X 
 
 
 
 
X 
 
 
X 
 
 
X 
Immunology (Serum)p 
X 
X 
 
 
 
 
X 
 
 
X 
 
 
X 
a. 
Screening assessment occurs from -60 days to -1 day prior to Day 0. If screening occurs within 14 days prior to Day 0, then do not repeat medical history prior to dosing. 
b. 
Follow-up phone call to collect AEs 
c. 
Full physical examination at screening and Week 48 (or any other study discontinuation visit) only. Targeted physical exam at all other visits. 
d. 
Includes Na, K, Cl, HCO3 or CO2, Ca, PO4, glucose, BUN, Cr, AST and ALT. 
e. 
MERS-CoV antibody (per PI discretion), HIV antibody or rapid test, HBsAg, HCV antibody. 
f. 
Dipstick for glucose, protein, and hematuria. Microscopic examination should be performed if dipstick is abnormal.  
g. 
Serum pregnancy test at screening. Urine pregnancy test at other visits.  
h. 
INO-4700 or placebo is prepared by unblinded pharmacy personnel. All doses delivered via ID injection followed by EP. 
i. 
For Study Groups A, B and F, one injection preferably over deltiod muscle at Day 0 and Week 4. For Study Groups E and I, two injections with each injection over a different deltoid or lateral 
quadriceps, preferably over the deltoid muscles, at Day 0 and Week 4. 
j. 
For Study Groups C and G, one injection preferably over deltoid muscle at Day 0 and Week 8. For Study Groups D and H, two injections with each injection over a different deltoid or lateral 
quadriceps, preferably over the deltoid muscles, at Day 0 and Week 8.  
k. 
Complete only for Study Groups A, B, E, F and I. 
l. 
Complete for Study Groups C, D, G and H. 
m. 
Following administration of INO-4700 or placebo, EP data will be downloaded from the CELLECTRATM 2000 device and provided to Inovio. 
n. 
Includes AEs from the time of consent and all injection site reactions that qualify as an AE.  
o. 
4 x 8.0 mL (32 mL) whole blood in Cell Preparation Tubes (CPT) per time point. Note: At the investigator’s discretion, rather than collecting a sample at screening, 64 mL (8 x 8.0 mL whole blood 
in CPT tubes) may be collected prior to dosing on Day 0. 
p. 
1 x 8 mL blood in 10 mL red top serum collection tube per time point. Note: Collect four aliquots of 1 mL each (total 4 mL) serum at each time point prior to 1st dose. At the investigator’s discretion, 
rather than collecting a sample at screening, 2 x 8 mL blood in two (2) 10 mL red top serum collection tubes (for eight aliquots of 1 mL each) may be collected prior to dosing on Day 0. 
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Clinical Protocol 
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Protocol Version: v2.0 
 
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TABLE 5 – PART 2 TRIAL SCHEDULE OF EVENTS (DAY 0 & WEEK 4 OPTIMAL REGIMEN) 
Tests and assessments 
Screena 
Day 0 
Week 2 
(± 3d) 
Week 4 
(± 5d) 
Week 6 
(± 5d) 
Week 8b 
(± 5d) 
Week 12 
(± 5d) 
Week 30b 
(± 10d) 
Week 48 
(± 5d) 
Week 50i 
(± 5d) 
Week 68i 
(± 10d) 
Pre Post 
Pre Post 
Pre Post 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history 
X 
Xa 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Concomitant Medications 
X 
X 
 
X 
X 
 
X 
 
 
 
X 
 
X 
X 
Physical Examc 
X 
X 
 
X 
X 
 
X 
 
 
 
X 
 
X 
X 
Vital Signs 
X 
X 
 
X 
X 
 
X 
 
 
 
X 
 
X 
X 
Height and Weight 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
CBC with differential 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
X 
X 
Chemistry and Liver Functiond 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
X 
X 
Serologye 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
12-lead ECG 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urinalysis Routinef 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
X 
X 
Pregnancy Testg 
X 
X 
 
 
X 
 
 
 
 
 
Xi 
 
 
 
INO-4700 or placebo + EPh 
 
X 
 
 
X 
 
 
 
 
 
Xi 
 
 
 
Download EP Dataj 
 
 
X 
 
 
X 
 
 
 
 
 
Xi 
 
 
Adverse Eventsk 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Xi 
X 
X 
Immunology (Whole blood)l 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
X 
X 
Immunology (Serum)m 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
X 
X 
a. 
Screening assessment occurs from -60 days to -1 day prior to Day 0. If screening occurs within 14 days prior to Day 0, then do not repeat medical history prior to dosing. 
b. 
Follow-up phone call to collect AEs. 
c. 
Full physical examination at screening and Week 48 (participants receiving only two doses) or Week 68 (participants receiving three doses), as well as any other study discontinuation 
visit. Targeted physical exam at all other visits. 
d. 
Includes Na, K, Cl, HCO3 or CO2, Ca, PO4, glucose, BUN, Cr, AST and ALT. 
e. 
MERS-CoV antibody (per PI discretion), HIV antibody or rapid test, HBsAg, HCV antibody. 
f. 
Dipstick for glucose, protein, and hematuria. Microscopic examination should be performed if dipstick is abnormal.  
g. 
Serum pregnancy test at screening. Urine pregnancy test prior to dosing at other visits.  
h. 
INO-4700 or placebo is prepared by unblinded pharmacy personnel. All doses delivered via ID injection followed by EP. 
i. 
Complete only for participants receiving a third dose of either INO-4700 or placebo (Part 2B). 
j. 
Following administration of INO-4700 or placebo, EP data will be downloaded from the CELLECTRATM 2000 device and provided to Inovio. 
k. 
Includes AEs from the time of consent and all injection site reactions that qualify as an AE.  
l. 
4 x 8.0 mL (32 mL) whole blood Cell Preparation Tubes (CPT) per time point. Note: At the investigator’s discretion, rather than collecting a sample at screening, 64 mL (8 x 8.0 mL whole blood 
in CPT tubes) may be collected prior to dosing on Day 0. 
m. 
1 x 8 mL blood in 10 mL red top serum collection tube per time point.  Note:  Collect four aliquots of 1 mL each (total 4 mL) serum at each time point prior to 1st dose. At the investigator’s 
discretion, rather than collecting a sample at screening, 2 x 8 mL blood in two (2) 10 mL red top serum collection tubes (for eight aliquots of 1 mL each) may be collected prior to dosing on Day 0. 
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Clinical Protocol 
Protocol Version Date: 12Feb2021 
CONFIDENTIAL 
Protocol Version: v2.0 
 
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TABLE 6 – PART 2 TRIAL SCHEDULE OF EVENTS (DAY 0 & WEEK 8 OPTIMAL REGIMEN) 
Tests and assessments 
Screena 
Day 0 
Week 2 
(± 3d) 
Week 4b 
(± 5d) 
Week 8 
(± 5d) 
Week 10 
(± 5d) 
Week 
12b 
(± 5d) 
Week 30b 
(± 10d) 
Week 48 
(± 5d) 
Week 50i 
(± 5d) 
Week 68i 
(± 10d) 
Pre Post 
Pre Post 
Pre Post 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history 
X 
Xa 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Concomitant Medications 
X 
X 
 
X 
 
X 
 
X 
 
 
X 
 
X 
X 
Physical Examc 
X 
X 
 
X 
 
X 
 
X 
 
 
X 
 
X 
X 
Vital Signs 
X 
X 
 
X 
 
X 
 
X 
 
 
X 
 
X 
X 
Height and Weight 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
CBC with differential 
X 
 
 
X 
 
 
 
X 
 
 
X 
 
X 
X 
Chemistry and Liver Functiond 
X 
 
 
X 
 
 
 
X 
 
 
X 
 
X 
X 
Serologye 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
12-lead ECG 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urinalysis Routinef 
X 
 
 
X 
 
 
 
X 
 
 
X 
 
X 
X 
Pregnancy Testg 
X 
X 
 
 
 
X 
 
 
 
 
Xi 
 
 
 
INO-4700 or placebo + EPh 
 
X 
 
 
 
X 
 
 
 
 
Xi 
 
 
 
Download EP Dataj 
 
 
X 
 
 
 
X 
 
 
 
 
Xi 
 
 
Adverse Eventsk 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Xi 
X 
X 
Immunology (Whole blood)l 
X 
X 
 
 
 
X 
 
X 
 
 
X 
 
X 
X 
Immunology (Serum)m 
X 
X 
 
 
 
X 
 
X 
 
 
X 
 
X 
X 
a. 
Screening assessment occurs from -60 days to -1 day prior to Day 0. If screening occurs within 14 days prior to Day 0, then do not repeat medical history prior to dosing. 
b. 
Follow-up phone call to collect AEs. 
c. 
Full physical examination at screening and Week 48 (participants receiving only two doses) or Week 68 (participants receiving three doses), as well as any other study discontinuation 
visit. Targeted physical exam at all other visits. 
d. 
Includes Na, K, Cl, HCO3 or CO2, Ca, PO4, glucose, BUN, Cr, AST and ALT. 
e. 
MERS-CoV antibody (per PI discretion), HIV antibody or rapid test, HBsAg, HCV antibody. 
f. 
Dipstick for glucose, protein, and hematuria. Microscopic examination should be performed if dipstick is abnormal.  
g. 
Serum pregnancy test at screening. Urine pregnancy test prior to dosing at other visits.  
h. 
INO-4700 or placebo is prepared by unblinded pharmacy personnel. All doses delivered via ID injection followed by EP. 
i. 
Complete only for participants receiving a third dose of either INO-4700 or placebo (Part 2B). 
j. 
Following administration of INO-4700 or placebo, EP data will be downloaded from the CELLECTRATM 2000 device and provided to Inovio. 
k. 
Includes AEs from the time of consent and all injection site reactions that qualify as an AE.  
l. 
4 x 8.0 mL (32 mL) whole blood in Cell Preparation Tubes (CPT) per time point. Note: At the investigator’s discretion, rather than collecting a sample at screening, 64 mL (8 x 8.0 mL whole 
blood in CPT tubes) may be collected prior to dosing on Day 0. 
m. 
1 x 8 mL blood in 10 mL red top serum collection tube per time point.  Note:  Collect four aliquots of 1 mL each (total 4 mL) serum at each time point prior to 1st dose. At the investigator’s 
discretion, rather than collecting a sample at screening, 2 x 8 mL blood in two (2) 10 mL red top serum collection tubes (for eight aliquots of 1 mL each) may be collected prior to dosing on Day 0. 
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Inovio Pharmaceuticals, Inc. 
 
Clinical Protocol 
Protocol Version Date: 12Feb2021 
CONFIDENTIAL 
Protocol Version: v2.0 
 
Page 21 of 75 
 
1.0 
INTRODUCTION 
This document is a protocol for a human research trial to be conducted according to US 
and international standards of Good Clinical Practice (GCP) (FDA Title 21 part 312, 812 
and International Conference on Harmonization (ICH) guidelines), applicable government 
regulations and Institutional research policies and procedures. 
1.1 
BACKGROUND AND SCIENTIFIC RATIONALE 
The lack of available therapy in conjunction with increasing numbers of global cases 
indicates that MERS-CoV infection remains a serious unmet medical need. Due to cross-
species infection, both human and animal outbreaks are possible. Appropriate measures 
to prevent, control and treat existing and future infections are needed. 
1.2 
BACKGROUND INFORMATION 
First reported in 2012 in a patient from Saudi Arabia presenting with pneumonia and acute 
kidney injury, Middle East Respiratory Syndrome Coronavirus (MERS-CoV) was originally 
known as coronavirus-EMS (Erasmus Medical Center) [1]. Although only more recently 
has human infection been identified, evidence suggests that MERS-CoV has existed in 
central and east Africa for decades [2]. MERS-CoV belongs to the family Coronaviridae, 
which includes four major groups: alpha, beta, gamma and delta. Although genomically 
related to the subgroup B beta-coronavirus severe acute respiratory syndrome (SARS) 
virus, MERS-CoV belongs to the subgroup C beta-coronavirus lineage. Two main 
recognized clades (clade A and B) of MERS-CoV have been identified by phylogenetic 
analysis, of which clade B can be further subdivided into five groups (groups I, II, III, IV, 
V). As a novel beta-coronavirus with high pathogenicity, significant morbidity and mortality 
is associated with infection of this subgroup, in contrast to less severe illness with other 
coronavirus infection [3]. 
Based on analyses of MERS-CoV’s evolutionary history, natural hosts include bats 
(species Neoromicia capensis and Vespertilio superans), dromedary camel (Camelus 
dromedarius) and European hedgehog (Erinaceus europaeus) [4-7]. Its high 
recombination potential and evasion of host immune responses provides coronaviruses 
the ability to infect multiple host species, thus supporting the contribution of zoonotic 
events to adaptive evolution and disease transmission. Notably, dromedary camels are 
the only documented cross-species source for human infection [8]. However, the 
mechanism by which transmission occurs from natural animal hosts to human is still poorly 
characterized [9]. 
Those in a healthcare setting or who have come into contact with camels constitute the 
majority of known exposure routes and potential source of transmission [10]. Indeed, 
nosocomial transmission due to inadequate infection control has been established as a 
major driver of MERS-CoV infections in humans [11, 12], and contributed to the 2014 
outbreak in Saudi Arabia and 2015 outbreak in South Korea. Primary cases tend to be 
middle-aged males and those with occupational exposure to animal hosts, while 
secondary cases include younger men and women and those who’ve come into contact 
with confirmed patients. 
1.2.1 CLINICAL PRESENTATION AND IMMUNE RESPONSE 
The incubation period for MERS-CoV is about 5-7 days and can be up to 12 days. MERS-
CoV infection causes lower respiratory tract disease due to the highly susceptible nature 
of respiratory epithelial cells [13]. As such, greater viral loads are detected in the lower 
respiratory tract compared to the upper tract. Renal, intestinal and liver cells and 
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b e e n o b s er v e d [ 1 0, 1 4]. S e v er e i nf e cti o n h a s b e e n a s s o ci at e d wit h a c ut e ki d n e y d a m a g e 
a n d r e s pir at or y di str e s s r e q uiri n g i nt e n si v e c ar e u nit m a n a g e m e nt wit hi n 2 d a y s of h o s pit al 
a d mi s si o n a n d c a n pr o gr e s s t o m ulti or g a n s y st e m f ail ur e [ 1 5]. S y m pt o m ati c p ati e nt s c arr y 
M E R S -C o V i n tr a c h e al a s pir at e s, s p ut u m a n d br o n c h o al v e ol ar l a v a g e fl u i d, a n d d u e t o 
c o nti n u o u s vir al s h e d di n g u p t o si x w e e k s, p ati e nt s m a y b e a bl e t o t r a n s mit vir u s e v e n 
w h e n a s y m pt o m ati c [ 1 6]. P o or er di s e a s e o ut c o m e a n d hi g h er m ort alit y m a y o c c ur i n ol d er 
or i m m u n o c o m pr o mi s e d p ati e nt s a n d t h o s e wit h c o m or bi diti e s, s u c h a s di a b et e s, c a n c er, 
a n d c ar di a c a n d c hr o ni c p ul m o n ar y di s e a s e [ 1 7].  
M ulti pl e st u di e s s u g g e st t h at h o st i m m u n e f u n cti o n a n d ki n eti c s ar e i m p ort a nt f a ct or s i n 
d et er mi ni n g di s e a s e c o ur s e. Alt h o u g h hi g h er a nti b o d y tit er s i n c orr el ati o n wit h gr e at er vir al 
l o a d a n d d el a y e d d e v el o p m e nt of n e utr ali zi n g a nti b o di es w er e a s s o ci at e d wit h p o or er 
pr o g n o si s, t h e pr ot e cti v e eff e ct of t h e s e a nti b o di e s d uri n g i nf e cti o n i s n ot cl e ar [ 1 8, 1 9] . 
A d diti o n all y, b ot h d ur ati o n a n d m a g nit u d e of  a nti b o d y r e s p o n s e i s i n di c ati v e of di s e a s e 
s e v erit y [ 2 0]. Fr o m a c ell ul ar i m m u nit y p er s p e cti v e, 
M E R S -C o V 
m a y d o w nr e g ul at e 
e x pr e s si o n of i nt erf er o n -sti m ul at e d g e n e s a n d d el a y i n d u cti o n of pr oi nfl a m m ator y 
c yt o ki n e s. C yt ot o xi c T c ell s ar e i m pli c at e d i n h o st d ef e n s e a n d r e c o v er y a s o n e st u d y 
r e p ort e d C D 8+  T c ell r e s p o n s e s i n s ur vi v or s d e s pit e t h e l a c k of a n a nti b o d y r e s p o n s e [ 1 8]. 
1. 2. 2  C U R R E N T T R E A T M E N T A N D U N M E T N E E D  
C urr e nt tr e at m e nt f o c u s e s o n s y m pt o m ati c s u p p orti v e c ar e. 
Ri b a viri n a n d I F N -α 2 b 
a d mi ni str ati o n h a v e b e e n s h o w n t o d e cr e a s e vir al r e pli c ati o n i n vitr o, i m pr o v e o ut c o m e s 
i n a ni m al s a n d i n cr e a s e s h ort-t er m s ur vi v al i n a r etr o s p e cti v e h u m a n st u d y [ 2 1, 2 2]. 
Ri b a viri n a n d I F N -α 2 b i n c o m bi n ati o n wit h l o pi n a vir i s c urr e ntl y b ei n g t e st e d i n a n 
i nt er v e nti o n al P h a s e 2 cli ni c al tri al ( cli ni c altri al s. g o v N C T 0 2 8 4 5 8 4 3) . 
Ot h er t ar g et s i n d e v el o p m e nt i n cl u d e vir al a n d h o st pr ot e a s e s a n d vir al e ntr y i n hi bit or s, 
s u c h a s i n hi biti o n of di p e pti d yl -p e pti d a s e 4 ( D P P 4 or C D 2 6) o n t h e h o st c ell. D P P 4 a ct s 
a s t h e m ai n r o ut e of e ntr y utili z e d b y t h e vir u s’ s pi k e ( S) pr ot ei n, w hi c h i s  t h e pri m ar y t ar g et 
f or n e utr ali zi n g a nti b o di e s. S p e cifi c all y, t w o 
m o n o cl o n al a nti b o di e s ( R E G N 3 0 5 1 a n d 
R E G N 3 0 4 8) ar e a bl e t o bi n d t h e r e c e pt or bi n di n g d o m ai n ( R B D) r e gi o n wit hi n t h e S pr ot ei n 
wit h hi g h affi nit y a n d n e utr ali z e 
M E R S -C o V i n vitr o [ 2 3]. I n 
m o u s e 
m o d el s, t h e s e 
a nt i b o di e s a ct a s i n hi bit or s a g ai n st t h e D P P 4 a n d S pr ot ei n i nt er a cti o n a n d h a v e s h o w n 
eff e cti v e n e s s i n r e stri cti n g 
M E R S -C o V r e pli c ati o n a n d i nf e cti o n [ 2 3, 2 4]. A d diti o n al 
m o n o cl o n al a nti b o di e s, all t ar g eti n g R B D, ar e b ei n g d e v el o p e d b y s e v er al gr o u p s [2 5] . 
I m p ort a ntl y, v a c ci n e s h a v e b e e n pri oriti z e d a s a pr o mi si n g alt er n ati v e. C urr e ntl y, t h er e ar e 
n o a p pr o v e d pr o p h yl a cti c n or t h er a p e uti c v a c ci n e s a v ail a bl e f or t h e pr e v e nti o n a n d 
tr e at m e nt of 
M E R S-C o V i nf e cti o n. 
V a c ci n e d e v el o p m e nt f or 
M E R S -C o V 
m a y b e 
c h all e n gi n g d u e t o t h e s p or a di c n at ur e of i nf e cti o n a n d l a c k of s uit a bl e a ni m al m o d el s f or 
c h all e n g e st u di e s. A d diti o n all y, d et er mi n a nt s of pr ot e cti o n a n d i m m u nit y ar e n ot cl e arl y 
d efi n e d. D e v el o p m e nt of b ot h vir al v e ct or -b a s e d a n d R B D -b a s e d f or m at s ar e o n g o i n g. 
R e pli c ati o n d efi ci e nt m o difi e d v a c ci ni a A n k ar a ( M V A) e x pr e s si n g f ull -l e n gt h M E R S-C o V 
s pi k e pr ot ei n a n d a d e n o vir u s v e ct or s h a v e d e m o n str at e d h u m or al a n d c ell ul ar i m m u n e 
r e s p o n s e s, b ut a d v er s e i nfl a m m ati o n a n d s af et y r e m ai n a c o n c er n [ 2 6]. A li v e -att e n u at e d 
M E R S -C o V v a c ci n e al s o e xi st s b ut w o ul d r e q uir e hi g h er bi o s af et y pr e c a uti o n s f or t e sti n g 
a n d w o ul d n ot b e f e a si bl e f or t h e t ar g et p o p ul ati o n m or e pr o n e t o s e v er e M E R S -C o V 
di s e a s e [ 2 7]. R B D -b a s e d v a c ci n e s ar e pr o p o s e d t o b e m or e eff e cti v e a n d s af er t h a n vir al 
v e ct or -b a s e d v a c ci n e s . I ntr a n a s al R B D-b a s e d i m m u ni z ati o n i n a ni m al s eli cit s str o n g 
m u c o s al I g A  r e s p o n s e s a s w ell a s s p e cifi c c ell -m e di at e d r e s p o n s e s t h at m a y c o ntri b ut e 
t o pr ot e cti o n [ 2 8, 2 9]. C o m bi n ati o n wit h a dj u v a nt s, s u c h a s al u mi n u m or oil -b a s e d M F 5 9, 
M E R S- 2 0 1 Pr ot oc ol | V V- T M F- 0 0 1 6 7 | 2. 0
D o w nl oa de d o n 1/ 9/ 2 0 2 3

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INO-4700 
  
MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Clinical Protocol 
Protocol Version Date: 12Feb2021 
CONFIDENTIAL 
Protocol Version: v2.0 
 
Page 24 of 75 
 
at Weeks 0, 4 and 12 in 75 healthy adult participants. Overall, transient local injection site 
discomfort and reactions were most commonly reported, consistent with previously 
published clinical trial reports of Inovio’s DNA delivered via EP platform. The most 
common solicited systemic adverse event was headache, followed by malaise and 
myalgia, most of which were mild. Laboratory abnormalities were uncommon, and no 
grade 3 or higher laboratory abnormalities were deemed related to the vaccine. No 
vaccine-related serious adverse events were reported. The vaccine was immunogenic in 
all dosing groups with remarkably similar antibody and neutralization titers between all 
three doses. These levels were comparable to those observed in convalescent patients 
who have recovered from MERS-CoV infection. Furthermore, the vaccine generated long-
lasting T cell responses that maintained average levels higher than convalescent patients 
for at least 60 weeks. Flow cytometry analysis and intracellular cytokine staining detected 
increases in CD8+ T cells secreting IFNγ and TNFα and CD4+ T cells secreting TNFα. In 
summary, the data from this first Phase 1 trial supports the strong immunogenicity of the 
vaccine and ability to induce durable immune responses for at least 1 year.   
In an ongoing Phase 1/2a dose-ranging clinical trial, the safety, tolerability and 
immunogenicity of GLS-5300 delivered intradermally (ID) followed by EP in 60 healthy 
volunteers is being evaluated. Dose levels include 0.3 mg administered in a three-
immunization regimen at Week 0, 4 and 12, 0.6 mg administered in a three-immunization 
regimen at Week 0, 4 and 12, and 0.6 mg administered in a two-immunization regimen at 
Week 0 and 8. As of June 2019, there have been no reports of treatment-associated 
serious adverse events and the majority of adverse events reported have been grade 1 or 
grade 2 in severity. Adverse event data standardization is in progress, but the most 
commonly reported adverse events are similar to that reported in the completed Phase 1 
trial.  
An interim analysis has showed that ID delivery of GLS-5300 induced a robust binding 
antibody and IFNγ cellular immune response in humans. A dose response was observed, 
such that the 0.6 mg dose induced significantly higher humoral and cellular immune 
responses. The 0.6 mg dose induced up to a 76% seroconversion rate following a single 
immunization, 88% seroconversion following the second immunization, and 100% 
seroconversion following the third. The 0.6 mg dose also induced robust cellular immune 
responses, with 56% responders after the second immunization and 78% responders after 
the third. The two-immunization regimen (Week 0 and 8 dosing) appeared to induce 
significantly higher antibody titers than the three-immunization regimen (Week 0, 4 12) as 
early as 2 weeks post second immunization, without affecting the cellular immune 
response. The overall response rate for the 0.6 mg dose, three-immunization regimen 
reached 92% after two immunizations and increased to 100% following the third 
immunization. The 0.6 mg dose, two-immunization regimen reached an overall response 
rate of 96% after only two immunizations.  
Results from the complete Phase 1 clinical trial as well as interim safety and 
immunogenicity results from the ongoing Phase 1/2a clinical trial support continued 
evaluation of this plasmid in a demographically relevant population.  
Intradermal delivery has been shown to be a more tolerable route of administration that 
induces superior humoral immune responses for previously evaluated DNA vaccines 
targeting viruses such as Ebola, Zika and HIV [39-41]. 
As such, Part I of the current clinical trial represents the dose-finding phase of the study 
to supplement previously amassed safety and immunogenicity data. Participants in Part 1 
will receive dosing on Day 0 and Week 4 or Week 8, with a starting dose of INO-4700 of 
MERS-201 Protocol | VV-TMF-00167 | 2.0
Downloaded on 1/9/2023

INO-4700 
  
MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Clinical Protocol 
Protocol Version Date: 12Feb2021 
CONFIDENTIAL 
Protocol Version: v2.0 
 
Page 25 of 75 
 
0.6 mg, which demonstrated robust immunogenicity in the Phase 1/2a trial of GLS-5300 
delivered ID followed by EP.  
Furthermore, a long-term kinetic study of serologic responses from patients who 
recovered during the 2015 South Korea outbreak reports more rapid waning of antibody 
response during the first 6 months of disease onset that stabilizes between 6 months to 1 
year [42]. Similarly, a study of survivors from the 2014 Saudi Arabia outbreak reports fewer 
patients with positive antibody response at 10 months following disease onset compared 
to 3 months [43]. As this data may indicate variable response over time, participants in 
Part 2 will receive dosing on Day 0 and Week 4 or 8 and a booster dose at Week 48 (only 
for the first 225 participants). Part 2 will thus confirm the optimal dose identified in Part 1 
and will serve to also evaluate the impact of a booster/third dose. 
Based on the at-risk population, active immunization should demonstrate ability to drive 
clinically relevant immune responses within 4-6 weeks of administration with long-term 
protection. Additionally, the WHO target product profile for a MERS-CoV vaccine suggests 
dosing regimens of no more than 3 doses in prophylactic settings and no more than 2 
doses in reactive settings, with short intervals between doses [44].  
1.3.2 DNA VACCINES 
Since the 1990s, a novel approach to vaccination against a broad array of target antigens 
and diseases has been in development. This involves the direct introduction of plasmid 
deoxyribonucleic acid (DNA) containing the gene encoding the immunogen against which 
an immune response is sought into appropriate host tissues and the in situ production of 
the target immunogen(s). This approach offers a combination of potential advantages, 
including the stimulation of both B and T-cell responses, stability of the vaccine across a 
broad temperature range, absence of infectivity of the immunogen itself, the speed with 
which the vaccine can be constructed (for example in the face of an epidemic or pandemic 
as it is the case here with SARS-CoV-2), and the relative ease and generic nature of large-
scale manufacture. Many scientific publications have addressed the potential of DNA 
vaccination [45-54]. Immune responses in animal models have been obtained using genes 
from a variety of infectious agents including influenza viruses, hepatitis B virus, human 
immunodeficiency virus, human papillomaviruses, Marburg virus, Middle East Respiratory 
Syndrome (MERS) coronavirus, rabies virus, Severe Acute Respiratory Syndrome 
(SARS) coronavirus, West Nile virus (WNV), Zika virus, and other infectious agents as 
plasmodium, mycoplasma, and many more [53, 55] In many cases, protection from 
disease in animal models has also been demonstrated.  
DNA vaccines are able to generate both CD4+ and CD8+ T cell responses. The ability to 
generate MHC-Class I restricted CD8+ T cells (cytolytic T lymphocytes), which generally 
are not made following administration of inactivated viruses, proteins or peptides, may be 
important for key responses against certain pathogens, as well as enabling cross-strain 
specific responses when many antibody responses are strain-specific. Because the 
encoded protein is synthesized in vivo by the host following administration, DNA vaccines 
can encode membrane-bound proteins instead of solely the soluble versions [56]. This 
can be important because key neutralizing epitopes are located in regions that would be 
excluded, or not formed in a monomeric truncated soluble version. Unlike certain other 
vectors (such as heterologous viral vectors), DNA vaccines do not stimulate adaptive 
immune responses against themselves, although the DNA itself does stimulate certain 
innate immune responses [57]. In other words, they do not generate anti-vector immunity 
that could stunt antigen-specific responses following multiple exposures. 
1.3.3 USE OF ELECTROPORATION WITH DNA VACCINES 
MERS-201 Protocol | VV-TMF-00167 | 2.0
Downloaded on 1/9/2023

INO-4700 
MERS-201 
Inovio Pharmaceuticals, Inc. 
Clinical Protocol 
Protocol Version Date: 12Feb2021 
CONFIDENTIAL 
Protocol Version: v2.0 
Page 26 of 75 
Electroporation (EP) enhances gene expression of plasmid DNA delivered by the 
intramuscular (IM) or intradermal (ID) routes of administration (Figure 2). Following IM or 
ID delivery of a DNA vaccine or therapeutic product, EP facilitates entry of the DNA into 
the target site: muscle or dermal cells. Following cellular uptake, there is efficient 
production of the proteins encoded by the DNA expression plasmid system. The different 
EP devices, each with varying electrical parameters and protocols, have been reviewed 
[58]. EP has been extensively tested in animal species such as dogs, pigs, cattle, and 
NHPs to deliver therapeutic genes that encode for a variety of hormones, cytokines, 
enzymes or antigens [58] for the activation of both cellular and humoral responses [59, 
60]. Importantly, immune responses generated by DNA vaccines delivered with EP are far 
superior to responses to the same vaccines delivered without EP [60]. IM and ID delivery 
of DNA vaccines with EP has been studied extensively, and optimum conditions for 
plasmid uptake and expression have been described for therapeutic indications, vaccines 
and tumor animal model systems [61, 62].  
The Inovio Pharmaceuticals constant current EP device [58] referred to as the 
CELLECTRA™ 2000 for ID administration (3P-ID) device will be used in this clinical trial. 
The ID route of delivery has been selected for INO-4700 based on recent findings from 
multiple DNA vaccine development programs where ID delivery has driven equivalent if 
not superior humoral and cellular responses while improving tolerability (clinicaltrials.gov 
NCT02464670, clinicaltrials.gov NCT02431767) [40]. 
Figure 2: How Electroporation Works in the Body 
1.4 
POTENTIAL BENEFITS AND RISKS 
As of September 30 2019, a total of 75 participants have been dosed with INO-4700 IM 
and 60 participants with INO-4700 ID. In studies of INO-4700 administered IM followed by 
EP using CELLECTRA™ 2000 devices in healthy volunteers the most frequently reported 
AE has been injection site pain (94.7%), of which all were Grade 2 or less. In the ongoing 
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study of INO-4700 administered ID followed by EP using CELLECTRA™ 2000 devices in 
healthy volunteers, the most frequently reported AE has been erythema (63.3%), of which 
all were Grade 1  (taken from unvalidated data as a preliminary analysis).  
No specific AE has been identified as a risk. There may be potential benefit for prevention 
of MERS infection in affected areas, but efficacy is still unknown. Data gathered in this 
trial will be useful for future development of this vaccine for MERS-CoV. 
Additional details regarding the benefits and risks for participants participating in this 
clinical trial may be found in the Investigator’s Brochure (IB). 
2.0 
OBJECTIVES AND PURPOSE 
The overall purpose of this clinical trial is to evaluate INO-4700 in a demographically 
relevant population with the eventual goal of preparation for both routine prophylaxis and 
use during an outbreak situation. 
2.1 
HYPOTHESIS 
A selected optimal dose of INO-4700 delivered ID followed by EP using CELLECTRATM 
2000 in healthy volunteers will be well tolerated, exhibit an acceptable safety profile and 
result in generation of immune responses to MERS-CoV. 
3.0 
CLINICAL TRIAL DESIGN AND ENDPOINTS 
This is a Phase 2a, randomized, blinded, placebo-controlled, multi-center trial to evaluate 
the safety, tolerability and immunological profile of INO-4700 administered by ID injection 
followed by EP using the CELLECTRATM 2000 device in healthy adult volunteers. The 
primary objectives of this trial are to evaluate the tolerability, safety and immunogenicity 
of INO-4700 administered by ID injection followed by EP in healthy adult volunteers 
according to the regimens outlined in Table 1, Table 2, Table 3 and Figure 1.  
Approximately 542 healthy volunteers will be evaluated across two (2) parts of this study, 
Part 1 and Part 2. INO-4700 or placebo (SSC-0001) will be administered ID in ~0.1 mL 
dose volume followed immediately by EP. 
Part 1 – Dose Finding 
In Part 1, approximately 192 participants ages 18-50 years will be assessed through five 
(5) dose levels and regimens. These five (5) dose levels and regimens will be evaluated 
across nine (9) groups designated Study Groups A, B, C, D, E, F, G, H and I. Study Groups 
A, B, C, D and E will receive INO-4700 and enroll approximately 32 participants per group. 
Study Groups F, G, H and I will receive placebo and enroll approximately 8 participants 
per group. 
Participants will be randomized to receive either INO-4700 or placebo according to the 
dosing schedule described in Table 1. All participants and all clinical site staff will remain 
blinded to the subject treatment allocation (i.e., INO-4700 or placebo) within each Study 
Group, with the exception of the site’s pharmacy personnel.  
Enrollment into all Study Groups will proceed in parallel. After the first four (4) participants 
in Active Study Groups and the first two (2) participants in Placebo Study Groups have 
Week 2 clinical laboratory and adverse event data available, the results will be reviewed 
by the DSMB (Figure 1). Enrollment will not be paused during this DSMB review, and 
screening and randomization may continue. 
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Upon completion of the Week 10 visit and availability of immunological data, Part 1 will be 
unblinded in order to allow for one regimen to be selected for advancement into Part 2. 
The Study Group with an optimal immune response, an acceptable safety profile and 
tolerant dosing regimen by Week 10 will be selected for Part 2. The Sponsor will remain 
blinded through Part 1 of the study until initiation of the Week 10 data review. 
All Part 1 participants will be followed for 48 weeks from the Day 0 dosing [i.e., Week 48 
will be the planned End of Study (EOS) visit]. 
Part 2 – Expansion   
In Part 2, approximately 350 participants will be evaluated across one (1) dose level and 
regimen as outlined in Table 2 and Table 3. The dose level and regimen will be identified 
based on the optimal dose selection from Part 1. Enrollment into Part 2 may begin 
following completion of the Week 10 optimal dose and regimen selection in Part 1 (i.e., 
prior to Week 48 completion in Part 1). 
In Part 2A, participants will be randomized to receive the optimal dose of active (INO-
4700) selected in Part 1 of this study or placebo (SSC-0001) (Figure 1). Approximately 
300 participants will receive INO-4700 and 50 participants will receive placebo. 
In Part 2B, the first 200 participants randomized to the Part 2A Active Study Group will 
receive a third dose of either INO-4700 or placebo at Week 48. Specifically, Study Group 
“Active – Booster” will receive INO-4700 at the first (Day 0), second (Week 4 or 8) and 
third (booster at Week 48) doses. Study Group “Active – Placebo” will receive INO-4700 
at the first (Day 0) and second (Week 4 or 8) doses, and placebo at the third (Week 48) 
dose. Similarly, in Part 2B, the first 25 participants randomized to the Part 2A Placebo 
Study Group will receive a third dose of placebo at Week 48. Collectively, these first 225 
participants will be followed for 68 weeks from the Day 0 dosing [i.e., Week 68 will be the 
planned End of Study (EOS) visit]. All remaining 125 participants in Part 2A (i.e., those 
receiving only 2 doses) will be followed for 48 weeks from the Day 0 dosing [i.e., Week 48 
will be the planned End of Study (EOS) visit]. 
All participants and all clinical site staff will remain blinded to the subject treatment 
allocation (i.e., INO-4700 or placebo), with the exception of the site’s pharmacy personnel. 
Enrollment into Active and Placebo Study Groups will proceed in parallel. No enrollment 
pauses are planned. 
Upon completion of the Week 12 visit and availability of immunological and safety data, 
group-level (INO-4700 or placebo) unblinded summaries of immunogenicity and safety will 
be produced. This Week 12 analysis will serve to inform product development goals. The 
Sponsor will continue to remain blinded to subject-level treatment allocation (i.e., INO-
4700 or placebo) for the remainder of the trial. 
DSMB for Parts 1 and 2 
The DSMB will remain unblinded throughout the duration of the study.  
In Part 1, the DSMB will review clinical laboratory and adverse event data for the first six 
(6) participants, 4 active and 2 placebos, in each Active and Placebo Study Group, 
respectively, after the Week 2 safety data are complete. The DSMB will again convene to 
review all available safety data for all Study Groups after approximately 50% of planned 
participants are enrolled (i.e., approximately 96 participants), and after enrollment is 
complete.  
Subsequently, the DSMB will convene approximately every three (3) calendar months 
thereafter until study completion. Enrollment pauses are not planned during any DSMB 
review in Part 1 nor 2. 
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Should the criteria for any stopping rule be met, at any time, the DSMB will be notified 
immediately, and the study may be paused or stopped if the DSMB considers the safety 
data unsatisfactory. In this case, further enrollment and administration of INO-4700 or 
placebo to participants will be paused for further evaluation. The Sponsor will perform an 
investigation and consult the DSMB and other experts, if needed, to determine whether to 
resume randomization and/or dosing of the remainder of the participants to the study or 
Study Group(s). 
3.1 
PRIMARY OBJECTIVES 
• 
Evaluate the tolerability and safety of INO-4700 administered by ID injection followed 
by EP in healthy adult volunteers 
• 
Evaluate the cellular (T cell) and humoral immune response to INO-4700 
administered by ID injection followed by EP for identification and confirmation of an 
optimal dose and regimen 
• 
Evaluate selected optimal dose for safety and immunogenicity 
3.2 
PRIMARY ENDPOINTS 
Safety Endpoints: 
• 
Incidence of adverse events by system organ class (SOC), preferred term (PT), 
severity and relationship to investigational product  
• 
Administration (i.e., injection) site reactions (described by frequency and severity)  
• 
Incidence of adverse events of special interest 
Immunogenicity Endpoints: 
• 
Overall Immune response 
o MERS-CoV antigen specific antibodies  
o Antigen-specific cytokine-producing T cell responses  
3.3 
EXPLORATORY OBJECTIVE  
• 
Evaluate the expanded immunological profile by assessing both T and B cell immune 
responses 
• 
Evaluate the cellular (T cell) and humoral immune response to INO-4700 
administered by ID injection followed by EP for impact of boosting with a third dose 
• 
Evaluate humoral immune response cross reactivity to other coronaviruses 
3.4 
EXPLORATORY ENDPOINT  
• 
Expanded immunological profile which may include (but not limited to) additional 
assessment of T and B cell numbers and T and B cell molecular changes by 
measuring immunologic proteins and mRNA levels of genes of interest at all weeks 
as determined by sample availability 
• 
Antibodies to other coronaviruses 
3.5 
SAFETY ASSESSMENT 
For Part 1, adverse events will be collected at every visit and safety samples will be 
drawn at Screening, Week 2, Week 6, Week 10 and Week 48. For Part 2, adverse events 
will be collected at every visit and safety samples will be drawn at Screening, Week 2, 
Week 6 (if optimal regimen includes dosing at Week 4), Week 10 (if optimal regimen 
includes dosing at Week 8), Week 48, Week 50 (for participants receiving three doses) 
and Week 68 (for participants receiving three doses). Refer to the Schedule of Events 
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Table 4, Table 5 and Table 6 for additional details. 
For both Parts 1 and 2, all adverse events, regardless of relationship, will be collected 
from the time of consent until study discharge. 
Additionally, for both Parts 1 and 2, a pregnancy test will be performed at screening and 
prior to each dose. 
3.6 
IMMUNOGENICITY ASSESSMENT 
For Part 1, immunology blood samples will be collected at Screening, Day 0, Week 6, 
Week 10and Week 48. For Part 2, immunology blood samples will be collected at 
Screening, Day 0, Week 6 (if optimal regimen includes dosing at Week 4), Week 8 (if 
optimal regimen includes dosing at Week 8), Week 10 (if optimal regimen includes dosing 
at Week 8), Week 12 (if optimal regimen includes dosing at Week 4), Week 48, Week 50 
(for Part 2B participants receiving three doses) and Week 68 (for Part 2B participants 
receiving three doses). Refer to the Schedule of Events Table 4, Table 5 and Table 6 for 
additional details. Determination of analysis of collected samples for immunological 
endpoints will be determined on an ongoing basis throughout the study. 
4.0 
CLINICAL TRIAL POPULATION 
4.1 
INCLUSION CRITERIA 
a. Able to provide informed consent and have signed Informed Consent Form (ICF) prior 
to screening procedures; 
b. For Part 1, adults age 18 and 50 years, inclusive. For Part 2, adults at least 18 years 
of age; 
c. Judged to be healthy by the Investigator on the basis of medical history, physical 
examination and vital signs performed at Screening. Note: Participants taking daily 
prescription or non-prescription medications for management of acceptable chronic 
medical conditions must be on a stable dose, as defined by non-change in dose for 
the 3 months prior to the first dose of study medication and no planned changes 
during the active dosing period of the study; 
d. Able and willing to comply with all study procedures; 
e. Screening laboratory results within normal limits for testing laboratory or deemed not 
clinically significant by the Investigator; 
f. Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C 
antibody and Human Immunodeficiency Virus (HIV) antibody or rapid test at 
screening; 
g. Screening ECG deemed by the Investigator as having no clinically significant findings 
(e.g. Wolff-Parkinson-White syndrome); 
h. Must meet one of the following criteria with respect to reproductive capacity: 
• 
Women who are post-menopausal as defined by spontaneous amenorrhea 
for ≥ 12 months; 
• 
Surgically sterile or have a partner who is sterile (i.e., vasectomy in males at 
least six (6) months prior to enrollment or tubal ligation, absence of ovaries 
and/or uterus in females); 
• 
Use of medically effective contraception with a failure rate of < 1% per year 
when used consistently and correctly from screening until 3 months following 
last dose. Acceptable methods include:  
‒ 
hormonal contraception including implants, injections or oral; 
‒ 
two barrier methods, e.g., condom and cervical cap (with spermicide) or 
diaphragm (with spermicide); 
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‒ 
abstinence when this is the subject’s preferred and usual lifestyle. Note: 
Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-
ovulation methods) and withdrawal are not acceptable methods of 
contraception. 
4.2 
EXCLUSION CRITERIA 
a. Pregnant or breastfeeding, or intending to become pregnant or father children within 
the projected duration of the trial starting with the screening visit until 3 months 
following last dose; 
b. Positive serum pregnancy test during screening or positive urine pregnancy test prior 
to dosing; 
c. History of respiratory diseases such as asthma, chronic obstructive pulmonary 
disease or chronic bronchitis; 
d. Is currently participating in or has participated in a study with an investigational 
product within 30 days preceding Day 0; 
e. Previous receipt of any vaccine within 30 days preceding Day 0 or planning to receive 
any vaccine during the timeframe restricted per the protocol; 
f. Previous receipt of an investigational vaccine product for prevention of MERS; 
g. Prior exposure to MERS-CoV or camels (serology or antibody testing will be 
requested at the Investigator’s discretion); 
h. Participants who participated in MERS-201 Part 1 cannot participate in MERS-201 
Part 2; 
i. 
Fewer than two acceptable sites available for ID injection and EP considering the 
deltoid and anterolateral quadriceps muscles. The following are unacceptable sites: 
• 
Tattoos, keloids or hypertrophic scars located within 2 cm of intended 
administration site; 
• 
Implantable-Cardioverter-defibrillator (ICD) or pacemaker (to prevent a life-
threatening arrhythmia) that is located ipsilateral to the deltoid injection site 
(unless deemed acceptable by a cardiologist); 
• 
Any metal implants or implantable medical device within the electroporation 
site; 
j. 
Prisoner or participants who are compulsorily detained (involuntary incarceration); 
k. Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, 
topical skin and/or eye drop-containing corticosteroids) prior to dosing. Systemic 
corticosteroids must be discontinued at least 3 months prior to first dose;  
l. 
Reported active drug or alcohol or substance abuse or dependence. 
4.3 
DISCONTINUATION/WITHDRAWAL OF CLINICAL TRIAL PARTICIPANTS 
Participants may withdraw consent at any time for any reason or be dropped from the trial 
at the discretion of the Investigator should any untoward effect occur. In addition, the 
Investigator or the Sponsor has the right to withdraw a subject from the trial at any time. 
The Investigator must notify the Sponsor immediately when a subject has been 
discontinued/withdrawn due to an Adverse Event (AE). If a subject discontinues from the 
trial or is withdrawn from the trial prior to trial completion, all applicable activities scheduled 
for the final trial visit (i.e., Part 1 Week 48 EOS or Part 2 Week 48 or 68 EOS) should be 
performed at the time of discontinuation. Any AEs and/or Serious Adverse Events (SAEs) 
present at the time of discontinuation/withdrawal should be followed in accordance with 
the safety requirements outlined in Section 7.9: Safety Data Reporting Period, Method of 
Collection and Submission. 
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Unless a subject refuses to continue participation, all follow-up visits and procedures 
should be completed as indicated in the Schedule of Events (Tables 3, 4 and 5) following 
the last dose whether or not the subject has completed all doses. 
 
Reasons for withdrawal from the trial may include but are not limited to the following: 
• 
Subject withdrawal of consent at any time 
• 
Any medical condition that the Investigator or Sponsor determines may jeopardize 
the subject’s safety if he or she continues in the trial 
• 
Investigator, DSMB or Sponsor determines it is in the best interest of the subject 
• 
Subject non-compliance 
 
Every effort should be made to obtain information on participants who withdraw from the 
trial. The primary reason for withdrawal from the trial should be documented on the 
appropriate eCRF. However, participants will not be followed for any reason after consent 
has been withdrawn. Data and/or samples collected prior to withdrawal of consent will be 
analyzed.  
 
Subject dosing may be discontinued if they experience any of the following: 
• 
Adverse Event (Adverse Reaction) 
o The Investigator or trial coordinator must notify the Sponsor immediately 
when a subject has been discontinued/withdrawn due to an Adverse Event 
(AE). 
• 
Any medical condition that may jeopardize the subject’s safety if he or she 
continues on trial  
• 
Pregnancy 
 
Subjects who discontinue or withdrawal from the study will not be replaced. 
5.0 
CLINICAL TRIAL TREATMENT 
5.1 
INVESTIGATIONAL PRODUCTS (IPS) AND STUDY DEVICE 
5.1.1 INO-4700 AND SSC-0001 
Investigational product is defined as a pharmaceutical form of an active ingredient or 
placebo being tested or used as a reference in the study, whether blinded or unblinded. 
INO-4700 is the active investigational product to be used in this study. The INO-4700 drug 
product contains 10 mg/mL pGX9101 in 1X SSC buffer (150 mM sodium chloride and 15 
mM sodium citrate). A volume of 0.4 mL will be filled into 2-mL glass vials that are fitted 
with rubber stoppers and sealed aluminum caps. INO-4700 must be placed in 2–8°C 
storage immediately upon arrival and requires preparation prior to administration, which 
is outlined in the pharmacy manual. 
pGX9101 is a DNA plasmid expressing a synthetic consensus (SynCon®) Middle East 
Respiratory Syndrome Human Coronavirus Spike protein (MERS-CoV Spike), driven by 
a human CMV promoter (hCMV promoter), and with the bovine growth hormone 3’ end 
poly-adenylation signal (bGH polyA). The pGX0001 backbone includes the kanamycin 
resistance gene (KanR) and plasmid origin of replication (pUC ori). 
Sterile saline sodium citrate (SSC) buffer (SSC-0001), which contains sterile 150 mM 
sodium chloride and 15 mM sodium citrate in 2-mL or 10-mL glass vials, stoppered, and 
sealed with aluminum caps, will be used as the placebo at the clinical site. 
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5.1.2 CELLECTRATM 2000 
The CELLECTRATM 2000 is a portable, battery-powered medical device designed to 
generate a minimally-controlled, electric field which temporarily and reversibly increases 
cellular membrane permeability without damaging the tissue. During the period of 
increased permeability an indicated injected plasmid DNA formulation can be introduced 
into the cells. 
The CELLECTRATM 2000 device is indicated to enhance the uptake and expression of 
DNA plasmid-based biologics in order to enhance vaccine efficacy. The DNA plasmid is 
delivered separately via needle and syringe injection immediately prior to the 
electroporation. The electroporation is accomplished through a sterile, disposable needle 
Array attached to an Applicator delivering current controlled electrical pulses as follows: 
• 
An EP treatment consists of four pulses. 
• 
An Array of three stainless steel electrode needles is used to deliver the electrical 
pulses into the tissue. 
• 
Voltage levels are limited to 200 volts (V) for patient safety.  
• 
The specified current is constantly maintained through voltage modulation using 
an analog feedback loop. Measurements of voltage and current are processed for 
error reporting and collected for data logging. 
The CELLECTRATM 2000 device for ID administration is comprised of three components: 
(1) A battery-powered Pulse Generator, (2) an ID Applicator that is connected to the pulse 
generator, and (3) a three-point sterile disposable ID Array of stainless steel needles. 
5.2 
TREATMENT REGIMENS 
• 
Part 1 Group A – One 0.6 mg ID injection of INO-4700 followed by EP administered at 
Day 0 and Week 4 (± 5 days) 
• 
Part 1 Group B – One 1.0 mg ID injection of INO-4700 followed by EP administered at 
Day 0 and Week 4 (± 5 days) 
• 
Part 1 Group C – One 1.0 mg ID injection of INO-4700 followed by EP administered at 
Day 0 and Week 8 (± 5 days) 
• 
Part 1 Group D – Two 0.5 mg ID injections (in an acceptable location on two different 
limbs) of INO-4700 followed by EP administered at Day 0 and Week 8 (± 5 days) 
• 
Part 1 Group E – Two 1.0 mg ID injections (in an acceptable location on two different 
limbs) of INO-4700 followed by EP administered at Day 0 and Week 4 (± 5 days) 
• 
Part 1 Group F – One ID injection of placebo followed by EP administered at Day 0 
and Week 4 (± 5 days) 
• 
Part 1 Group G – One ID injection of placebo followed by EP administered at Day 0 
and Week 8 (± 5 days) 
• 
Part 1 Group H – Two ID injections (in an acceptable location on two different limbs) 
of placebo followed by EP administered at Day 0 and Week 8 (± 5 days) 
• 
Part 1 Group I – Two ID injections (in an acceptable location on two different limbs) of 
placebo followed by EP administered at Day 0 and Week 4 (± 5 days) 
• 
Part 2 – Dose and regimen to be determined, each ID injection(s) followed by EP 
administered at Day 0, Week 4 or Week 8, and Week 48 (for Part 2B participants 
receiving a third dose) 
INO-4700 or placebo will be administered intradermally in ~0.1 mL dose volume followed 
immediately by EP. 
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5.2.1 BLINDING 
This trial is randomized across Study Groups, is blinded to the Investigator and subject, 
and is placebo-controlled with blinding throughout the duration of the trial as described in 
Section 3: Clinical Trial Design and Endpoints. There is no difference in appearance 
between INO-4700 and SSC-0001; however, they may be packaged in different sized 
vials. To maintain the blind, vials will only be handled by designated unblinded personnel 
(site pharmacist) at the site. The Sponsor will also be blinded as described in Section 3: 
Clinical Trial Design and Endpoints. 
The PI may request to unblind a subject’s dose assignment in case of an emergency or 
serious medical condition when knowledge of the study product or dose is essential for 
proper clinical management of the subject, as judged by the PI. It is preferred, but not 
required, that the PI first contact the Medical Monitor (MM) to discuss options before 
unblinding the subject’s dose assignment. In case of non-emergency, PI must contact MM 
to discuss the options before unblinding the subject’s dose assignment. 
The Sponsor’s pharmacovigilance staff may unblind a subject’s dose assignment for an 
SAE, unanticipated adverse device effect (UADE), or adverse event of special interest 
(AESI) with the study product when the event is assessed as related and unexpected. If 
expedited regulatory reporting is required for an event, the report may be submitted to 
regulatory authorities with the subject’s dose assignment, in accordance with local 
regulations.  
5.3 
PACKAGING AND LABELING 
5.3.1 INO-4700 / SSC-0001 
This trial is randomized and blinded across study groups and placebo-controlled. 
Therefore, the subject and the Investigator’s clinical site personnel (except for the site 
pharmacy) are blinded to INO-4700 and SSC-0001. Each vial of investigational product 
will be labeled consistent with the example product label provided in Table 7 and Table 
8). 
Table 7: Investigational Labels for INO-4700 Drug Product and SSC-001 on Vials 
Protocol Number ID: MERS-201 
INO-4700 (10 mg/mL) 
0.4mL/Vial 
Single Use Vial 
Solution for Intradermal injection 
Lot:  
Date of Manufacture:  
Expiry Date:  
Store at 2-8°C 
CAUTION: New Drug for Investigational Use Only.  
INOVIO PHARMACEUTICALS, USA 
 
Treatment No. ____________________ 
Subject No.  ____________________ 
 
Protocol Number: MERS-201 
Sterile SSC Buffer for Dilution 
SSC-0001 (X mL/Vial) 
Solution for Intradermal injection 
Lot:  
Date of Manufacture:  
Expiry Date:  
Store at 2-8°C 
CAUTION: New Drug for Investigational Use Only.  
INOVIO PHARMACEUTICALS, USA 
Treatment No. ____________________ 
Subject No.  ____________________ 
 
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Table 8: Investigational Labels for INO-4700 Drug Product and SSC-0001 on 
Cartons 
Protocol Number: MERS-201 
INO-4700 (10 mg/mL) 
Lot: 
Date of Manufacture: 
Expiry Date: 
0.4mL/Vial 
Single Use Vial 
Solution for Intradermal injection. Use in accordance 
with protocol. 
Storage Condition: Store between 2-8°C. Do not 
freeze. 
CAUTION: New Drug for Investigational Use Only. 
Keep out of reach of children. 
Sponsor: Inovio Pharmaceuticals, Inc. 660 W. 
Germantown Pike, Suite 110, Plymouth Meeting, PA 
19462 USA Phone: +1-267-440-4257 
The package is intended for export from the United 
States. 
Treatment No. _______________________ 
Investigator Name   ____________________ 
Subject No.  ____________________ 
Visit No.:    ____________________ 
Visit Date:   ____________________ 
Protocol Number: MERS-201 
Sterile SSC Buffer for Dilution 
SSC-0001 (X mL/Vial) 
Lot: 
Date of Manufacture: 
Expiry Date: 
Solution for Intradermal injection. Use in accordance 
with protocol. 
Storage Condition: Store between 2-8°C. Do not 
freeze. 
CAUTION: New Drug for Investigational Use Only. 
Keep out of reach of children. 
Sponsor: Inovio Pharmaceuticals, Inc. 660 W. 
Germantown Pike, Suite 110, Plymouth Meeting, PA 
19462 USA Phone: +1-267-440-4257 
The package is intended for export from the United 
States. 
Treatment No. _____________________ 
Investigator Name ____________________ 
Subject No.  ____________________ 
Visit No.: ____________________ 
Visit Date: ____________________ 
5.3.2 CELLECTRATM 2000 
Please see shipping box for shipping documents and contents, and User Manual for 
unpacking instructions. 
The CELLECTRATM 2000 device and its components bear labels that identify the device 
name and place of business of the manufacturer. The CELLECTRATM 2000 User Manual 
describes all relevant contraindications, hazards, potential risks and adverse effects, 
interfering substances or devices, warnings, and precautions. Each CELLECTRATM 2000 
Pulse Generator has a unique serial number, and each ID Applicator has a unique serial 
number. Each ID Array has a Lot Number and Expiration Date. Examples of device labels 
are provided in the IB. 
The CELLECTRATM 2000 device, and its components, will be shipped directly from the 
manufacturer to the study site. 
5.4 
HANDLING AND STORAGE 
5.4.1 INO-4700 AND SSC-0001 
INO-4700 and SSC-0001 will be shipped at 2–8°C. If the temperature monitoring devices 
in the shipping container(s) denote temperatures outside this 2–8°C (36-46°F) range, the 
Sponsor, or its designee, should be contacted immediately. 
Upon arrival, it must be transferred from the shipping container into 2–8°C (36-46°F) 
storage, in a secure area, in accordance with local regulations by designated unblinded 
personnel (e.g., pharmacy personnel). The Sponsor must be notified of any deviations 
from this storage condition. Refrigerator temperature logs must be maintained at the 
clinical site and temperatures must be recorded and monitored regularly. For further 
details see Pharmacy Manual and IB. 
5.4.2 CELLECTRATM 2000 
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See User Manual for operating and storage conditions. 
5.5 
PREPARATION AND DISPENSING 
INO-4700 is supplied in single dose 2-mL vials at a concentration of 10 mg/mL at a 
minimum volume of 0.4 mL. SSC-0001 is supplied in 2-mL or 10-mL vials at a minimum 
volume of 1.1 mL or 2 mL. 
Blinded staff involved in the clinical execution of the study should not come in contact with 
vials of INO-4700 or SSC-0001. Vials will only be handled by designated unblinded 
personnel (e.g., pharmacy) at the site. When a participant is eligible for enrollment, 
unblinded personnel will fill INO-4700 or SSC-0001 into a blinded syringe in accordance 
with the subject’s randomization code. The syringe will be transferred to blinded site 
personnel for administration. The preparation and dispensing information is provided in 
the Pharmacy Manual. A randomization schedule will be generated by the Sponsor 
statistician. 
5.6 
USE OF STUDY DEVICE 
The CELLECTRATM 2000 is an investigational device. The instructions for use of the 
CELLECTRATM 2000 device are provided in the User Manual. Each clinical site will receive 
training for use of the CELLECTRATM 2000 device prior to first dose.  
The EP procedure must be performed by qualified personnel. Any individual designated 
to perform the procedure should be permitted by the relevant local authorities to administer 
parenteral injections to patients (e.g., MD, DO, RN) in addition to successfully completing 
device training from Sponsor personnel.  
5.7 
INVESTIGATIONAL DRUG AND STUDY DEVICE ACCOUNTABILITY 
5.7.1 INO-4700 AND SSC-0001 ACCOUNTABILITY 
It is the responsibility of the Investigator to ensure that a current record of investigational 
products accountability is maintained at the study site. The investigational products must 
have full traceability from the receipt of the products through participant use, disposal or 
return of the products. Records or logs must comply with applicable regulations and 
guidelines. The accountability information is provided in the Pharmacy Manual. 
5.7.2 CELLECTRATM 2000 ACCOUNTABILITY 
The investigative site is responsible for maintaining device accountability logs. The device 
must have full traceability from the receipt of the products through participant use, disposal 
or return of the products. The site must document acknowledgement of receipt and notify 
Inovio upon receipt of study devices. This includes the content shipped and condition upon 
receipt. 
For each subject administration, there must be a record of each product used for that 
participant, i.e., CELLECTRATM 2000 Pulse Generator serial number, ID Applicator serial 
number, and ID Array lot number. The ID Applicator is reusable with a new ID Array and 
sheath for each procedure. The sterile ID Array and sheath are single use only and must 
be discarded after use in accordance with institutional policy regarding disposal of sharp 
needles/instruments. 
5.8 
RETURN AND DESTRUCTION OF INVESTIGATIONAL DRUG AND STUDY DEVICE 
5.8.1 INO-4700 AND SSC-0001 
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Upon completion or termination of the study, all unused IP (INO-4700 and SSC-0001) 
must be destroyed at the study site in accordance with institution policy or returned to 
Inovio Pharmaceuticals, Inc. or its designee if the site cannot destroy IP. 
The used IP vials will be discarded in accordance with the site’s used IP disposal 
procedure. It is the Investigator’s responsibility to arrange for disposal of all empty vials, 
provided that procedures for proper disposal have been established in accordance with 
applicable national, local and institutional guidelines and procedures, and provided that 
appropriate records of disposal are kept. All precautions must be taken to maintain blind 
throughout this process. If requested by the Sponsor, the return of unused IP should be 
arranged by the responsible Inovio Representative. The unused IP can only be destroyed 
after being inspected and reconciled by the responsible Inovio Pharmaceuticals, Inc. 
personnel or designated unblinded Clinical Monitor. If IP is returned to Inovio 
Pharmaceuticals, Inc., or its designee, the IP must be accompanied by the appropriate 
documentation. The return of unused IP(s) should be arranged with the responsible Inovio 
personnel and/or unblinded Clinical Monitor. 
5.8.2 RETURN OF CELLECTRATM 2000 
Upon completion or termination of the study, an Inovio Representative will provide 
instructions regarding the component(s) to be returned to Inovio Pharmaceuticals, Inc., 
destroyed onsite or shipped to a destruction vendor. 
All product returned to Inovio Pharmaceuticals, Inc. must be accompanied by the 
appropriate return documentation. Returned supplies should be in the original containers. 
The return of all product identified above should be arranged by the Inovio Representative. 
The ID Arrays should be discarded in the sharps container immediately after use. The 
used ID Applicators can either be destroyed at the site, shipped to a destruction vendor, 
or returned to Inovio. If the used ID Applicators are destroyed on site, it is the Investigator’s 
responsibility to ensure that arrangements have been made for the disposal, written 
authorization has been granted by Inovio Pharmaceuticals, Inc., or its designee, 
procedures for proper disposal have been established in accordance with applicable 
regulation and guidelines and institutional procedures, and appropriate records of the 
disposal have been documented. 
6.0 
CLINICAL TRIAL PROCEDURES AND SCHEDULE 
The trial Schedule of Events ( 36TTables 4, 5 and 636T) in the Clinical Protocol Synopsis 
summarizes the trial procedures to be performed at each visit. Individual trial procedures 
are described in detail below. It may be necessary to perform these procedures at 
unscheduled time points if deemed clinically necessary by the Investigator. A subject will 
be required to provide informed consent (Section 6.2) prior to any study procedure being 
performed. Protocol waivers or exemptions will not be granted. Therefore, adherence to 
the study design and assessments are essential and required for study conduct. 
6.1 
PROCEDURE BY VISIT 
Refer to Sections 6.1.1 and 6.1.2 for study procedures and the times at which they are to 
be performed. 
6.1.1 CLINICAL TRIAL SCREENING EVALUATIONS 
The assessments performed during Screening will determine the subject’s eligibility for 
the study and also their ability to comply with protocol requirements by completing all 
screening assessments. Participants’ post-menopausal status must meet requirements as 
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specified in the inclusion criteria [63, 64]. The following screening evaluations will be 
performed within 60 days prior to dosing on Day 0. All screening assessment values must 
be reviewed prior to the first Study IP administration.  
If a subject does not meet an inclusion or exclusion criterion due to a transient and non-
clinically significant event at Screening, relevant Screening evaluations may be repeated 
within the same 60 day Screening period. If the participant fails twice, they will be 
considered a screen failure. 
• 
Signed and dated informed consent (Section 6.2); 
• 
Review and confirm all inclusion/exclusion criteria (Section 4.1 and 4.2); 
• 
Obtain and document complete medical history, surgical history (including all past 
procedures), present conditions and concomitant illnesses (Section 6.1.1.1); 
• 
Collect demographics, including gender, and document any ongoing, pre-existing 
conditions; 
• 
Collect adverse events (Section 6.4.4); 
• 
Record current concomitant medications/treatments (Section 6.4.7); 
• 
Full physical examinations (Section 6.4); 
• 
Record vital signs including body weight and height, heart rate (HR), respiratory 
rate (RR), blood pressure (BP) and oral temperature (Section 6.4); 
• 
Collect blood for CBC with differential, serum chemistry (sodium [Na], potassium 
[K], chloride [Cl], bicarbonate [HCO3 or CO2], calcium [Ca], phosphate [PO4], 
glucose, blood urea nitrogen [BUN] and creatinine [Cr]) and liver function [alanine 
aminotransferase (ALT) and aspartate aminotransferase (AST)] (Section 6.4); 
• 
Perform 12 lead ECG (Section 6.4); 
• 
Collect urine for routine urinalysis (Section 6.4); 
• 
Collect blood for serum pregnancy test (Section 6.4); 
• 
Collect serum for MERS-CoV (per PI discretion), HIV, Hepatitis B surface antigen 
(HBsAg) and Hepatitis C serology (Section 6.4) per national guidelines; 
• 
Collect whole blood and serum for immunology assessment (Section 6.4.6).  At 
the investigator’s discretion, this sample collection may be postponed to Day 0, at 
which time both the screening and Day 0 samples would be collected prior to 
dosing. 
6.1.1.1 
Medical History 
A medical history will be obtained by the Investigator or qualified designee at the time of 
Screening. Medical history will include all active conditions, and any other past conditions, 
as well as surgical procedures, that are considered to be clinically significant by the 
Investigator and/or occurred within the 12 weeks prior to Screening. Illnesses first 
occurring or detected after the signing of the informed consent, or during the study and/or 
worsening of an existing illness in severity, frequency or nature after signing of the 
informed consent are to be documented as AEs on the CRF. Prior treatments, defined as 
administered up to 12 weeks prior to the time of informed consent and stopped prior to 
dosing on Day 0, should be recorded in the CRF as prior medications. Concomitant 
treatments, defined as continuing or new treatments taken at or after the signing of the 
informed consent, should be recorded in the CRF as concomitant medications. 
6.1.2 
CLINICAL TRIAL EVALUATIONS AND PROCEDURES 
Once eligibility has been confirmed, the participant will be assigned to receive IP. Visit 
dates and windows must be calculated from Day 0, unless otherwise noted. All study 
groups in Part 1 will be followed until Week 48, booster dose participants in Part 2 will be 
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followed to Week 68 and all other participants in Part 2 who did not receive booster dose 
will be followed to Week 48. All participants will be followed in accordance with 
assessments outlined below. 
6.1.2.1 
Day 0  
The following evaluations will be performed on Day 0 prior to IP administration: 
• 
Collect all present and/or new or ongoing adverse events; 
• 
Document any present conditions and concomitant illnesses; 
• 
Record current concomitant medications/treatments (Section 6.4.7); 
• 
Targeted physical examination (Section 6.4); 
• 
Record vital signs (Section 6.4); 
• 
Collect urine for urine pregnancy test (Section 6.4); 
• 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
 
The following evaluation will be performed on Day 0 prior to EP: 
• 
Assess for injection site for IP leakage (Section 6.4.1) 
 
The following evaluations will be performed on Day 0 after IP plus EP administration: 
• 
Collect any new adverse events; 
• 
Download EP Data (Section 6.4.1.1). 
6.1.2.2 
Week 2 
Calculated from Day 0, the following evaluations will be performed at this visit: 
• 
Collect all present and/or new or ongoing adverse events; 
• 
Document any present conditions and concomitant illnesses; 
• 
Record current concomitant medications/treatments (Section 6.4.7); 
• 
Targeted physical examination (Section 6.4); 
• 
Record vital signs (Section 6.4); 
• 
Collect blood for CBC with differential, serum chemistry and liver function (Section 
6.4); 
• 
Collect urine for routine urinalysis (Section 6.4); 
6.1.2.3 
Week 4 
Part 1 
The following evaluations will be performed on Week 4 (complete prior to IP 
administration for Part 1 Study Groups A, B, E, F and I): 
• 
Collect all present and/or new or ongoing adverse events; 
• 
Document any present conditions and concomitant illnesses; 
• 
Record current concomitant medications/treatments (Section 6.4.7); 
• 
Targeted physical examination (Section 6.4); 
• 
Record vital signs (Section 6.4); 
• 
Collect urine for urine pregnancy test (Section 6.4) for Part 1 Study Groups A, B, 
E, F and I only. 
 
The following evaluation will be performed on Week 4 prior to EP (for Part 1 Study 
Groups A, B, E, F and I only): 
• 
Assess for injection site for IP leakage (Section 6.4.1) 
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The following evaluations will be performed on Week 4 after IP administration (for Part 
1 Study Groups A, B, E, F and I only): 
• 
Collect any new adverse events; 
• 
Download EP Data (Section 6.4.1.1). 
 
Part 2 if Day 0/Week 4 Dosing Regimen is Optimal 
The following evaluations will be performed on Week 4 (complete prior to IP 
administration if following Table 5): 
• 
Collect all present and/or new or ongoing adverse events; 
• 
Document any present conditions and concomitant illnesses; 
• 
Record current concomitant medications/treatments (Section 6.4.7); 
• 
Targeted physical examination (Section 6.4); 
• 
Record vital signs (Section 6.4); 
• 
Collect urine for urine pregnancy test (Section 6.4). 
 
The following evaluation will be performed on Week 4 prior to EP (if following Table 5 
only): 
• 
Assess for injection site for IP leakage (Section 6.4.1) 
The following evaluations will be performed on Week 4 after IP administration (if 
following Table 5 only): 
• 
Collect any new adverse events; 
• 
Download EP Data (Section 6.4.1.1). 
 
Part 2 if Day 0/Week 8 Dosing Regimen is Optimal 
The following evaluation will be collected on Week 4 (if following Table 6 only) during a 
follow-up phone call visit: 
• 
Collect all present and/or new or ongoing adverse events. 
6.1.2.4 
Week 6 
Calculated from Week 4 if Week 4 is a dosing visit, the following evaluations will be 
performed at this visit for Part 1 and Part 2 if Day 0/Week 4 dosing regimen is optimal: 
• 
Collect all present and/or new or ongoing adverse events; 
• 
Document any present conditions and concomitant illnesses; 
• 
Record current concomitant medications/treatments (Section 6.4.7); 
• 
Targeted physical examination (Section 6.4); 
• 
Record vital signs (Section 6.4); 
• 
Collect blood for CBC with differential, serum chemistry and liver function (Section 
6.4); 
• 
Collect urine for routine urinalysis (Section 6.4); 
• 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
6.1.2.5 
Week 8 
Part 1 
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The following evaluations will be performed on Week 8 (complete prior to IP 
administration for Part 1 Study Groups C, D, G and H): 
• 
Collect all present and/or new or ongoing adverse events; 
• 
Document any present conditions and concomitant illnesses; 
• 
Record current concomitant medications/treatments (Section 6.4.7); 
• 
Targeted physical examination (Section 6.4); 
• 
Record vital signs (Section 6.4); 
• 
Collect urine for urine pregnancy test (Section 6.4) for Part 1 Study Groups C, D, 
G and H only. 
 
The following evaluation will be performed on Week 8 prior to EP (for Part 1 Study 
Groups C, D, G and H only): 
• 
Assess for injection site for IP leakage (Section 6.4.1) 
 
The following evaluations will be performed on Week 8 after IP administration (for Part 
1 Study Groups C, D, G and H only): 
• 
Collect any new adverse events; 
• 
Download EP Data (Section 6.4.1.1). 
 
Part 2 if Day 0/Week 4 Dosing Regimen is Optimal 
The following evaluation will be collected on Week 8 (if following Table 5 only) during a 
follow-up phone call visit: 
• 
Collect all present and/or new or ongoing adverse events. 
 
Part 2 if Day 0/Week 8 Dosing Regimen is Optimal 
The following evaluations will be performed on Week 8 (complete prior to IP 
administration if following Table 6): 
• 
Collect all present and/or new or ongoing adverse events; 
• 
Document any present conditions and concomitant illnesses; 
• 
Record current concomitant medications/treatments (Section 6.4.7); 
• 
Targeted physical examination (Section 6.4); 
• 
Record vital signs (Section 6.4); 
• 
Collect urine for urine pregnancy test (Section 6.4). 
• 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
 
The following evaluation will be performed on Week 8 prior to EP (if following Table 6 
only): 
• 
Assess for injection site for IP leakage (Section 6.4.1) 
 
The following evaluations will be performed on Week 8 after IP administration (if 
following Table 6 only): 
• 
Collect any new adverse events; 
• 
Download EP Data (Section 6.4.1.1). 
6.1.2.6 
Week 10 
Calculated from Week 8 if Week 8 is a dosing visit, the following evaluations will be 
performed at this visit for Part 1 and Part 2 if Day 0/Week 8 dosing regimen is optimal: 
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• 
Collect all present and/or new or ongoing adverse events; 
• 
Document any present conditions and concomitant illnesses; 
• 
Record current concomitant medications/treatments (Section 6.4.7); 
• 
Targeted physical examination (Section 6.4); 
• 
Record vital signs (Section 6.4); 
• 
Collect blood for CBC with differential, serum chemistry and liver function (Section 
6.4); 
• 
Collect urine for routine urinalysis (Section 6.4); 
• 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
6.1.2.7 
Week 12  
Part 1 
The following evaluations will be collected during the follow-up phone call visit: 
• 
Collect all present and/or new or ongoing adverse events. 
Part 2 if Day 0/Week 4 Dosing Regimen is Optimal 
The following evaluations will be performed at this visit: 
• 
Collect all present and/or new or ongoing adverse events; 
• 
Document any present conditions and concomitant illnesses; 
• 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
 
Part 2 if Day 0/Week 8 Dosing Regimen is Optimal 
The following evaluations will be collected during the follow-up phone call visit: 
• 
Collect all present and/or new or ongoing adverse events. 
6.1.2.8 
Week 30 
The following evaluations will be collected during the follow-up phone call visit: 
• 
Collect all present and/or new or ongoing adverse events. 
6.1.2.9 
Week 48  
Part 1 
The following evaluations will be performed at this visit (End of Study visit): 
• 
Collect all present and/or new or ongoing adverse events; 
• 
Document any present conditions and concomitant illnesses; 
• 
Record current concomitant medications/treatments (Section 6.4.7); 
• 
Full physical examination (Section 6.4); 
• 
Record vital signs (Section 6.4); 
• 
Collect blood for CBC with differential, serum chemistry and liver function (Section 
6.4); 
• 
Collect urine for routine urinalysis (Section 6.4); 
• 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
 
Part 2  
The Week 48 visit will be the End of Study visit for participants receiving only two doses. 
The Week 48 visit will be the last dosing visit for participants receiving three doses. The 
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following evaluations will be performed on Week 48 (complete prior to IP administration 
for Part 2 participants receiving a third/booster dose): 
• 
Collect all present and/or new or ongoing adverse events; 
• 
Document any present conditions and concomitant illnesses; 
• 
Record current concomitant medications/treatments (Section 6.4.7); 
• 
Targeted physical examination (Section 6.4) for Part 2 participants receiving a 
third/booster dose; 
• 
Full physical examination (Section 6.4) for Part 2 participants receiving two doses 
only; 
• 
Record vital signs (Section 6.4); 
• 
Collect blood for CBC with differential, serum chemistry and liver function (Section 
6.4); 
• 
Collect urine for routine urinalysis (Section 6.4); 
• 
Collect urine for urine pregnancy test (Section 6.4) for Part 2 participants receiving 
a third/booster dose; 
• 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
 
The following evaluation will be performed on Week 48 prior to EP (for Part 2 
participants receiving a third/booster dose only): 
• 
Assess for injection site for IP leakage (Section 6.4.1) 
 
The following evaluations will be performed on Week 48 after IP administration (for Part 
2 participants receiving a third/booster dose only): 
• 
Collect any new adverse events; 
• 
Download EP Data (Section 6.4.1.1). 
6.1.2.10 
Week 50  
Calculated from Week 48.  The following evaluations will be performed at this visit only 
for Part 2 participants receiving a third/booster dose: 
• 
Collect all present and/or new or ongoing adverse events; 
• 
Document any present conditions and concomitant illnesses; 
• 
Record current concomitant medications/treatments (Section 6.4.7); 
• 
Targeted physical examination (Section 6.4); 
• 
Record vital signs (Section 6.4.); 
• 
Collect blood for CBC with differential, serum chemistry and liver function (Section 
6.4); 
• 
Collect urine for routine urinalysis (Section 6.4); 
• 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
6.1.2.11 
Week 68  
The following evaluations will be performed at this visit (End of Study Visit) only for Part 
2 participants receiving a third/booster dose: 
• 
Collect all present and/or new or ongoing adverse events; 
• 
Document any present conditions and concomitant illnesses; 
• 
Record current concomitant medications/treatments (Section 6.4.7); 
• 
Full physical examination (Section 6.4); 
• 
Record vital signs (Section 6.4); 
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• 
Collect blood for CBC with differential, serum chemistry and liver function (Section 
6.4); 
• 
Collect urine for routine urinalysis (Section 6.4); 
• 
Collect whole blood and serum for immunology assessment (Section 6.4.6). 
6.2 
INFORMED CONSENT 
All participants must sign the informed consent prior to participating in any clinical trial-
related procedures. The informed consent documentation must be in compliance with 
applicable regulations and GCP. Qualified clinical trial personnel will: 
• 
Meet with prospective clinical trial participants 
• 
Explain the clinical trial 
• 
Provide clinical trial participants with an Informed Consent Form (ICF) that includes 
the following in a language that is understandable to the subject: 
• 
Screening test(s) description 
• 
Eligibility criteria for entering the clinical trial 
• 
Clinical trial treatments and follow-up procedures description 
• 
Explanation of the clinical trial, including but is not limited to: 
• 
Clinical trial objectives 
• 
Potential benefits and risks 
• 
Discomforts/inconveniences 
• 
Subject’s rights and responsibilities 
The subject or subject’s legally authorized representative is then requested to sign and 
date the ICF. A copy of the signed informed consent documentation must be provided to 
the subject or subject’s legally authorized representative. The qualified clinical trial 
personnel will document the process of obtaining informed consent within the source 
record. Signed ICFs are maintained in the subject’s source records and must be 
accessible for verification at any time. Signing of the ICF begins the 60 day screening 
window. 
6.3 
ASSIGNMENT OF SUBJECT IDENTIFICATION NUMBERS 
Each subject who consents will be assigned a unique subject identification number (SID), 
which identifies the subject for all clinical trial-related procedures. SIDs are a combination 
of a four digit site code and a four digit subject number starting with 0001. After SIDs are 
assigned, they cannot be reused or reassigned for any reason. Information regarding the 
SID and screen date will be documented on a screening and enrollment log/system and 
in the Case Report Form (CRF). 
Participants meeting eligibility criteria listed in the protocol will be randomized by a 
computer generated allocation schedule. 
6.4 
SAFETY EVALUATIONS 
PHYSICAL EXAM AND TARGETED PHYSICAL ASSESSMENTS 
A full physical examination will be conducted during Screening and at study discharge/End 
of Study visit (i.e., Week 48, Week 68 or any other study discontinuation visit). A targeted 
physical assessment will be performed at other visits as determined by the Investigator or 
directed per subject complaints. 
VITAL SIGNS 
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Vital signs including oral temperature, respiration rate, blood pressure and heart rate will 
be measured at Screening and at select visits during the study.  
HEIGHT AND WEIGHT 
Weight (kg) and height (cm) will be collected at Screening. 
12-LEAD ECG 
A single 12-lead ECG will be performed at Screening for all participants to determine 
eligibility. ECG results obtained within 60 days of Day 0 are acceptable. The ECG should 
include measurements of ventricular rate, PR, QRS, QT, QTcb or QTcf, as well as an 
assessment of whether the ECG is normal or abnormal. Abnormal ECGs should be 
interpreted as clinically significant or not clinically significant. Dosing will be delayed in the 
event of a clinically significant abnormal pre-dose ECG until it has been reviewed by the 
PI, qualified PI designee, MM or Sponsor consultant cardiologist and deemed safe to 
proceed. 
LABORATORY EVALUATIONS 
At Screening and select visits during the study, blood samples will be collected for safety 
and immunology assessments. Approximately 250 mL and 240-340 mL of blood will be 
drawn from each subject in Part 1 and Part 2, respectively, over the course of the study. 
Participants may be asked to come back for additional blood draws if collected blood 
sample is lost or unevaluable for any reason. 
Hematology [Complete blood count (CBC) with automated differential]: 
White blood cell (WBC) count, red blood cell (RBC) count, hemoglobin, hematocrit and 
platelet count will be measured at Screening and select visits during the study. 
Serum chemistry: 
Electrolytes [Sodium (Na), Potassium (K), Chloride (Cl), Bicarbonate (HCO3 or CO2), 
Calcium (Ca), Phosphate (PO4)], glucose, BUN (blood urea nitrogen), and Creatinine (Cr) 
will be measured at Screening and select visits during the study. 
Liver function: 
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) will be measured 
at Screening and select visits during the study. 
Urinalysis:  
Urine samples will be tested by dipstick for glucose, protein, and hematuria at Screening 
and select visits during the study. If abnormal (presence of protein, hematuria, or glucose 
≥ 1+), a microscopic examination should be performed.  
Serology: 
Antibodies to MERS-CoV (per PI discretion), Hepatitis B surface antigen (HBsAg), 
Hepatitis C antibody and HIV antibody or rapid test will be measured at Screening only. 
Pregnancy Testing:  
For women of childbearing potential (WOCBP), a serum pregnancy test will be obtained 
at Screening and a urine pregnancy test will be performed prior to any dosing. A negative 
result for urine β-HCG (test must have a sensitivity of at least 25 mIU/mL) must be 
available prior to each administration of IP. If the β-HCG test is positive, indicating that the 
participant is pregnant prior to completing the specified dose regimen, then no further IP 
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will be administered. Every attempt should be made to follow pregnant participants for the 
remainder of the study and to determine the outcome of the pregnancy. 
6.4.1 
INJECTION AND EP  
Participants in Part 1 Study Groups A, B and C will receive one injection of INO-4700 in 
a volume of ~0.1 mL by ID injection above an acceptable muscle location for injection, 
the injection site is assessed for IP leakage, and the injection is followed immediately by 
EP. Part 1 Study Groups D and E will receive two injections of INO-4700, each in a 
volume of ~0.1 mL, above an acceptable muscle location on two different limbs, the 
injection site is assessed for IP leakage, and the injection is followed immediately by EP. 
Part 1 Study Groups F and G will receive one injection of placebo in a volume of ~0.1 mL 
by ID injection above an acceptable muscle location for injection, the injection site is 
assessed for IP leakage, and the injection is followed immediately by EP. Part 1 Study 
Groups H and I will receive two injections of placebo, each in a volume of ~0.1 mL, above 
an acceptable muscle location on two different limbs, the injection site is assessed for IP 
leakage, and the injection is followed immediately by EP. 
 
Participants in Part 2 will receive one or two injections per dosing visit of the optimal dose 
of INO-4700 or placebo in volume of ~0.1 mL by ID injection above an acceptable skin 
location for injection, the injection site is assessed for IP leakage, and the injections is 
followed immediately by EP.  
 
Only if the deltoid muscle is not a suitable location (see exclusion criterion ‘h’), the ID 
injection can then be administered above the lateral quadriceps followed immediately by 
EP. IP must not be given within 2 cm of a tattoo, scar, keloid, previous injection site at the 
same dosing visit, or active lesion/rash. Also, ID injection followed immediately by EP must 
not be performed on the skin of an extremity which has any metal implants or implantable 
medical device (e.g., surgical rods, pins or joint replacements). If a subject has an 
implanted cardiac defibrillator or pacemaker, ID injection/EP must not be performed above 
the deltoid muscle on the same side of the body where the device is located. 
6.4.2 
MANAGEMENT OF ANXIETY AND PAIN DUE TO ELECTROPORATION (EP) 
PROCEDURES 
Participants may be offered topical anesthetic (e.g., EMLA or equivalent) to prevent 
discomfort from the injection/EP procedure. If a topical anesthetic is used, an approximate 
1.5 cm diameter amount will be applied without occlusion to the administration site ~30 
minutes prior to injection/EP.  
Participants may be offered a mild sedative (e.g., 0.5-1 mg lorazepam or equivalent) for 
anxiety related to the injection/EP procedure. Mild sedatives may be administered 
approximately 1 hour prior to injection/EP on dosing visits. Participants who receive a mild 
sedative must not be allowed to operate a motor vehicle for 3-4 hours after receiving 
medication and should have arranged transportation to depart the study site. 
In case of pain, participants may be treated with a non-narcotic analgesic (e.g., ibuprofen, 
ketorolac) after injection/EP.  
Participants who are allergic to or have contraindications to EMLA, ibuprofen, ketorolac or 
a mild sedative may be offered a suitable alternative. 
Medication taken for pain management will be documented as concomitant medications. 
6.4.3 
ASSESSMENT OF LABORATORY ABNORMALITIES 
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Blood will be drawn for serum chemistry, liver function, and hematology and urinalysis 
performed at the visits listed in the Schedule of Events (Tables 3, 4 and 5) as listed in 
Section 6.4.  
Laboratory AEs will be assessed and graded in accordance with the “Toxicity Grading 
Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical 
Trials”, issued in September 2007 (Appendix A). 
6.4.4 
ASSESSMENT OF CLINICAL TRIAL ADVERSE EVENTS (AES) 
Participants will be queried regarding the occurrence of any adverse events including 
adverse events related to injection site reactions, concomitant medications and new onset 
illness or disease during their study visits. Participants will be reminded to contact study 
personnel and immediately report any event for the duration of the study. All adverse 
events will be captured from the time of informed consent until study discharge. These 
events will be recorded on the subject’s CRF. 
6.4.5 
ASSESSMENT OF INJECTION SITE REACTIONS  
The IP administration procedure consists of an ID injection (formation of a wheal) of IP 
followed by insertion of the ID Array needles (electrodes) through the skin and into the 
wheal followed by delivery of the electroporation pulses. This procedure is broadly 
described as administration because it involves more than the injection of a drug. 
Consequently, reactions arising from the IP administration procedure may be reported as 
administration site or injection site reactions. When evaluating administration (injection) 
site reactions throughout the study, it is most important to be as specific as possible by 
selecting the most appropriate term (see Table 9 below) and use the grading scale as 
listed in the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled 
in Preventive Vaccine Clinical Trials, issued September 2007 (Appendix A). Administration 
(injection) site reactions and administration site pain will be evaluated starting 30 minutes 
following injection/EP. In addition, other events associated with administration (injection) 
site reactions (e.g., hematoma, infection or necrosis) should also be reported with 
preferred terms specific for administration (injection) site reactions.  
Table 9: Grading Scale for Injection Site Reactions 
Local Reaction to 
Injectable Product 
(Grade) 
Mild (1) 
Moderate (2) 
Severe (3) 
Potentially Life 
Threatening (4) 
Pain 
Does not 
interfere with 
activity 
Repeated use 
of non-narcotic 
pain reliever 
>24 hours or 
interferes with 
activity 
Any use of 
narcotic pain 
reliever or 
prevents daily 
activity 
Emergency room 
visit or 
hospitalization 
Tenderness 
Mild discomfort 
to touch 
Discomfort with 
movement 
Significant 
discomfort at 
rest 
ER visit or 
hospitalization 
Erythema/Rednessa 
2.5-5 cm 
5.1-10 cm 
>10 cm 
Necrosis or 
exfoliative 
dermatitis 
Induration/Swellingb 
2.5-5 cm and 
no interference 
w/ activity 
5.1-10 cm or 
interferes with 
activity 
>10 cm or 
prevents daily 
activity 
Necrosis 
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September 2007 “FDA Guidance for Industry-Toxicity Grading Scale for Healthy Adult and 
Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials” 
a In addition to grading the measured local reaction at the greatest single diameter, the 
measurement should be recorded as a continuous variable 
b Should be evaluated and graded using the functional scale as well as the actual measurement. 
6.4.6 
PERIPHERAL BLOOD IMMUNOGENICITY ASSESSMENTS 
Whole blood and serum samples will be obtained to assess overall immune response. 
Immunology blood and serum samples are to be collected at Screening and select visits 
during the study. Both Screening and Day 0 immunology samples are required to enable 
all immunology testing. However, at the Principal Investigator’s discretion, collection of the 
screening immunology samples may be postponed and collected along with the Day 0 
samples. Details of the immunology sample collection and shipment information will be 
provided in the Laboratory Manual. The T and B cell immune responses to INO-4700 will 
be measured using assays that include but are not limited to ELISA, neutralization, 
assessment of immunological gene expression, assessment of immunological protein 
expression, flow cytometry and ELISPOT.  
An immune responder is defined as having either an increase in vaccine antibody titer 
compared to baseline or an increase in the number of vaccine specific IFN-gamma 
secreting cells as compared to baseline.   
Determination of analysis of collected samples for immunological endpoints will be 
determined on an ongoing basis throughout the study. 
6.4.7 
CONCOMITANT MEDICATIONS/TREATMENTS 
All medications (prescription and nonprescription) taken at the time of Screening and 
ongoing from signing of the informed consent to study discharge that do not affect a 
subject’s eligibility for participation (see Section 4.2) must be recorded on the case report 
forms (CRFs). 
Actual or estimated start and stop dates must be provided. This information will be 
obtained from the subject and abstracted from any available medical records. The 
indication for the medication, dose, and dose regimen will be documented.  
Therapy considered necessary for the subject’s welfare may be given at the discretion of 
the Investigator. If the permissibility of a specific medication/treatment is in question, 
please contact the Sponsor. 
The decision to administer a prohibited medication/treatment (Section 6.4.8) is made with 
the safety of the clinical trial subject as the primary consideration. When possible, the 
Sponsor should be notified before the prohibited medication/treatment is administered. 
6.4.8 
RESTRICTIONS  
Participants should refrain from becoming pregnant until 3 months following the last dose 
of investigational product by using appropriate contraceptive measures (see Section 4.1). 
Participants must not be vaccinated (e.g., influenza vaccine, COVID-19 vaccine) from 30 
days prior to Day 0 until after completion of the study visit 2 weeks after the second dose 
of investigational product (i.e. the Week 6 visit if the second dose is at Week 4 and the 
Week 10 visit if the second dose is at Week 8). For Part 2B, receipt of other vaccinations 
is also prohibited from 2 weeks prior to the Week 48 visit through the Week 50 visit. 
Participants must not receive a course of systemic corticosteroids (≥2 mg/kg of prednisone 
or equivalent for 5 days) within 3 months prior to any dose of investigational product. 
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Participants must not have fever (oral temperature >38.0 degrees Celsius or 100.4 
degrees Fahrenheit) within 72 hours prior to each dose of investigational product. 
7.0 
EVALUATION OF SAFETY AND MANAGEMENT OF TOXICITY 
7.1 
SAFETY PARAMETERS 
The safety of INO-4700 will be measured and graded in accordance with the “Toxicity 
Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive 
Vaccine Clinical Trials”, issued September 2007 (Appendix A). 
7.2 
ADVERSE EVENTS (AES) 
Any untoward medical occurrence in a patient or clinical investigation subject administered 
a pharmaceutical product and which does not necessarily have to have a causal 
relationship with this treatment.  
An AE can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding, for example), symptom, or disease temporally associated with the use 
of a medicinal product, whether or not considered related to the medicinal product.  
Adverse Events (AEs) include the following: 
• Pre- or post-treatment complications that occur as a result of protocol mandated 
procedure during or after screening (before the administration of clinical trial drug) 
• Any pre-existing condition that increases in severity, or changes in nature during or as 
a consequence of the clinical trial drug administration phase 
• Complications of pregnancy (refer to Section 7.11) 
Adverse Events (AEs) do not include the following: 
• Medical or surgical procedures (e.g., surgery, endoscopy, tooth extraction, transfusion) 
performed; however, the condition that leads to the procedure is an AE 
• Pre-existing diseases or conditions or laboratory abnormalities present or detected 
before the Screening Visit that do not worsen 
• Situations where an untoward medical occurrence has not occurred (e.g., 
hospitalization for elective surgery, social and/or convenience admissions) 
• Overdose without clinical sequelae 
• Any medical condition or clinically significant laboratory abnormality with an onset date 
before the ICF is signed, is not an AE; it is considered to be pre-existing and will be 
documented on the medical history CRF 
• Uncomplicated pregnancy 
• An induced elective abortion to terminate a pregnancy without medical reason 
7.3 
ADVERSE DRUG REACTION (ADR) 
All noxious and unintended responses to a medicinal product related to any dose. This 
means that a causal relationship between the medicinal product and an adverse event is 
at least a reasonable possibility (i.e., the relationship cannot be ruled out). 
7.4 
SERIOUS ADVERSE EVENTS (SAES) 
An SAE is any untoward medical occurrence that at any dose: 
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• Results in death  
• Is life-threatening 
o Refers to an event in which the participant was at risk of death at the time of the 
event. It does not refer to an event which hypothetically might have caused death 
if it were more severe. 
• Requires inpatient hospitalization or prolongation of existing hospitalization 
o Includes any hospitalization in which the participant has been admitted to the 
hospital regardless the length of stay, even if the hospitalization is only a 
precautionary measure to allow continued observation. However, hospitalization 
(including hospitalization for an elective procedure) for a pre-existing condition that 
has not worsened, does not constitute an SAE. 
• Results in persistent or significant disability/incapacity 
o A substantial disruption of a person's ability to conduct normal life functions (i.e., 
the adverse event resulted in a significant, persistent or permanent change, 
impairment, damage or disruption in the participant's body function/structure, 
physical activities and/or quality of life). 
• Results in congenital anomaly or birth defect and/or 
• An important medical event  
o An event that may not be immediately life-threatening or result in death or 
hospitalization but may jeopardize the participant or may require intervention to 
prevent one of the other outcomes listed above. Examples of such events are 
intensive treatment in an emergency room or at home for allergic bronchospasm, 
blood dyscrasias or convulsions that do not result in hospitalization, or 
development of drug dependency or drug abuse. 
Clarification of Serious Adverse Events (SAEs) 
• Death in itself is not an AE. Death is an outcome of an AE, but when the cause of death 
has not been provided, use the event term: death of unknown cause. 
• The participant may not have been receiving an investigational medicinal product at the 
occurrence of the event. 
• Complications that occur during hospitalizations are AEs. If a complication prolongs the 
hospitalization, it is an SAE. 
7.5 
UNEXPECTED ADVERSE DRUG REACTION 
An adverse reaction, the nature or severity of which is not consistent with the applicable 
product information (e.g., Investigator’s Brochure [IB] for an unapproved investigational 
product, package insert/summary of product characteristics for an approved product). 
7.6 
UNANTICIPATED (SERIOUS) ADVERSE DEVICE EFFECT (UADE) 
A UADE is any serious adverse effect on health or safety or any life-threatening problem 
or death caused by, or associated with, a device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the investigational plan 
or application (including a supplementary plan or application), or any other unanticipated 
serious problem associated with a device that relates to the rights, safety, or welfare of 
participants.  
A UADE is a type of SAE that requires reporting to the Sponsor in accordance with Section 
7.9. 
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7.7 
DEVICE DEFICIENCY 
A device deficiency is an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. 
Note: Device deficiencies include malfunctions, use errors and inadequate labelling. 
7.8 
SAFETY AND TOXICITY MANAGEMENT 
The Medical Monitor is responsible for the overall safety monitoring of the clinical trial. 
Safety monitoring assessments include but are not limited to:  
• Incidence of all adverse events classified by system organ class, preferred term,
severity and causal relationship to clinical trial treatment
• Changes in laboratory parameters
• Local and systemic injection site review; special attention will be paid to the examination
of the injection site
7.8.1 
ADVERSE EVENT OF SPECIAL INTEREST (AESI) 
An adverse event of special interest (serious or non-serious) is one of scientific and 
medical concern specific to the Sponsor’s product or program, for which ongoing 
monitoring and rapid communication by the PI to the Sponsor can be appropriate.  
For the purpose of this clinical trial, the AESIs listed in Appendix B are to be reported to 
the Sponsor in accordance with Section 7.9. 
7.8.1.1 
Management of COVID-19 Infection and COVID-19 Immunization 
COVID-19 is categorized as an Adverse Event of Special Interest (AESI).  If a participant 
experiences symptoms suggestive of COVID-19, the participant should inform the 
Principal Investigator. Based on the assessment of the Principal Investigator and further 
investigation, participants with a confirmed COVID-19 diagnosis should be managed 
according to standard of care.  
If the Principal Investigator believes that the participant should be managed beyond the 
routine care that can be provided by the study site, the participant should be referred to 
their primary health care provider or a medical treatment facility for further management. 
On recovery, the participant should continue with the study dosing and procedures if 
deemed fit by the Principal Investigator, in accordance with Section 4.3.  If the participant 
is not deemed fit to continue dosing or to continue certain follow-up procedures, (e.g. blood 
draws), the investigator should continue to follow the participant for safety, performing 
those procedures deemed acceptable, through the remainder of the trial. 
If participants are treated or hospitalized due to their illness and cannot return for follow-
up visits, the study team should request COVID-19 specific test results, treatments, 
treatment outcomes and diagnostics. These results and diagnostics will be recorded in the 
safety database in accordance with Section 7.9. 
For a participant that is scheduled to receive a COVID-19 vaccine, or has received the 
vaccine for COVID-19, all efforts should be made to remain within the timelines for 
vaccination outlined in Sections 4.2 and 6.4.8.   
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All efforts to continue study procedures must be undertaken by the site and the participant 
should be followed according to the protocol requirements for an AESI (Section 7.9). 
7.8.2 
ABNORMAL LABORATORY VALUE 
The PI will annotate each abnormal lab value as clinically significant (CS) or not clinically 
significant (NCS). 
Laboratory values that are NCS in the PI’s opinion should not be reported as an adverse 
event. 
Any abnormal laboratory value that is new in onset or worsened in severity or frequency 
from the baseline condition and meets one of the following criteria will be recorded as an 
AE: 
•
Requires therapeutic intervention or diagnostic tests
•
Leads to discontinuation of further administration of the investigational product in
the clinical trial
•
Has accompanying or inducing symptoms or signs
•
Is judged by the PI as clinically significant (CS)
Abnormal laboratory values that meet the criteria of an AE or SAE should be reported in 
accordance with Section 7.9. 
7.8.3 
CLINICAL TRIAL STOPPING RULES 
The stopping rules for this study are any of the following: 
•
Any study treatment-related SAE.
•
Any Grade 4 toxicities related to study treatment.
•
Any report of anaphylaxis from study treatment.
7.9 
Should the criteria for any stopping rule be met, at any time, the DSMB will be notified, 
and the study may be paused or stopped if the DSMB considers the safety data 
unsatisfactory. In this case, further enrollment and administration of INO-4700 or placebo 
to participants will be paused for further evaluation. The Sponsor will perform an 
investigation and consult the DSMB and other experts, if needed, to determine whether to 
resume randomization and/or dosing of the remainder of the participants to the study or 
Study Group(s). 
SAFETY DATA REPORTING PERIOD, METHOD OF COLLECTION AND SUBMISSION 
All AEs will be collected from the time informed consent is obtained until study discharge. 
This information will be captured in the Electronic Data Capture (EDC) system. 
If the PI determines that the AE meets serious criteria, then the AE will be recorded as an 
SAE. 
SAEs and AESIs will be reported to the Sponsor from the time the subject signs the 
informed consent until last visit. 
All SAEs (regardless of causal relationship) and AESIs will be reported on the SAE Report 
Form and submitted to the Sponsor within 24 hours of becoming aware of the event. 
The SAE Report Form will be either emailed to safety.inovio@apcerls.com  or faxed to 
. The original SAE Report Form must be kept at the clinical trial site.
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The event will be data entered into the EDC. 
For the events that are considered an AESI, the PI will contact the Sponsor within 24 hours 
of becoming aware of the event to discuss whether dosing should continue. 
Table 10: SAE Contact Information 
Sponsor Safety Email: safety.inovio@apcerls.com 
Sponsor Safety Fax: 
 
Sponsor Safety Phone: 
 
Table 11: Medical Monitor Direct Contact Information 
 MD 
Email: 
 
Cell Phone: 
 
All SAEs and AESIs must be followed by the PI until resolution or return to baseline status, 
or stabilization of the event (i.e., the expectation that it will remain chronic), even if it 
extends beyond the clinical trial reporting period. 
Follow-up information is to be submitted to the Sponsor on an SAE Report Form and within 
24 hours of becoming aware of the information. 
If medical records are submitted to the Sponsor with the SAE Report Form, the clinical 
trial site must: 
• Redact the medical records of all personal data (e.g., confidential subject data,
Personal Identifying Information [PII])
• Provide the subject’s assigned identification number (SID) on the records
All SAE and AESI information reported to Inovio will be entered into the Inovio safety 
database. 
7.10 ADVERSE EVENT REPORTING 
This section provides details on reporting the safety information. 
7.10.1 SUBMITTING THE INITIAL SERIOUS ADVERSE EVENT (SAE) REPORT FORM 
The PI should include as much safety information as possible when submitting the initial 
report, but the report must include the following at a minimum:  
•
The adverse event
•
The subject’s assigned identification number (SID)
•
Investigational product(s) (IP) and/or study device
•
Investigator causal relationship to the IP(s) and/or study device
•
Serious criteria
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• 
Reporter name and contact information 
If a case is submitted to the Sponsor with only the “minimum” information, a more detailed 
or updated follow-up report will be sent to the Sponsor as soon as possible but no later 
than three (3) calendar days after the date of the initial report. 
7.10.2 RECORDING THE EVENT 
Principal Investigators (PIs) should use correct medical terminology/concepts when 
recording adverse events on the EDC and SAE Report Form. The use of colloquialisms 
and abbreviations should be avoided. 
A medical diagnosis, if known, should be recorded rather than individual signs and 
symptoms. However, if the signs and/or symptoms cannot be medically characterized as 
a single diagnosis or syndrome, each individual sign and/or symptom should be recorded. 
If a diagnosis is subsequently established, all previous signs and/or symptoms will be 
subsumed and replaced with a single medical diagnosis. 
7.10.3 ASSESSING SEVERITY (INTENSITY) 
Severity is used to describe the intensity of a specific event (e.g., mild, moderate, severe). 
The PI will assess and grade clinical AEs or SAEs (based on discussions with clinical trial 
participants) in accordance with Toxicity Grading Scale for Healthy Adult and Adolescent 
Volunteers Enrolled in Preventive Vaccine Clinical Trials (Food and Drug Administration 
[FDA] Guidance for Industry) (Appendix A). 
7.10.4 CAUSAL RELATIONSHIP OF CLINICAL MATERIAL TO ADVERSE EVENTS (AES) 
A causally related AE is one judged to have a possible, probable or definite relationship 
to the administration of the IP and/or the study device. An AE may also be assessed as 
not related to the IP and/or the study device. Because the PI is knowledgeable about the 
subject (e.g., medical history, concomitant medications), administers the IP, and monitors 
the subject’s response to the IP, the PI is responsible for reporting AEs and judging the 
relationship between the administration of the IP and EP and a subsequent AE. The PI is 
aware of the subject’s clinical state and may have observed the event, and thus may be 
sensitive to distinctions between events due to the underlying disease process versus 
events that may be product-related.  
Principal Investigators (PIs) should use their knowledge of the clinical trial subject, the 
circumstances surrounding the event, and an evaluation of any potential alternative 
causes to determine whether an AE is considered to be related to the IP and/or the study 
device and the causal relationship reported as "Yes" or "No" accordingly. Causality should 
be assessed by the PI as related to drug, related to device, or related to both drug and 
device (i.e., related to both or indiscernible) by the following criteria: 
• 
Yes – there is a reasonable possibility that administration of the clinical trial 
treatment (drug or device or both drug and device) contributed to the event 
• 
No – there is no reasonable possibility that administration of the clinical trial 
treatment contributed to the event and there are more likely causes 
The following guidance should also be taken into consideration: 
• 
Temporal relationship of event to administration of IP and/or EP 
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• 
Course of the event, considering especially the effects of dose reduction, 
discontinuation of IP, or reintroduction of IP (where applicable) 
• 
Known association of the event with the IP, EP or with similar treatments 
• 
Known association of the event with the disease under trial 
• 
Presence of risk factors in the clinical trial participant or use of concomitant 
medications known to increase the occurrence of the event 
The rationale for the PI’s causal assessment is to be recorded on the SAE Report Form. 
The Sponsor will assess the overall safety of the IP delivered by EP and determine 
whether to report expeditiously to the regulatory authority(ies). 
7.11 REPORTING PREGNANCY DURING THE CLINICAL TRIAL 
Participants who are pregnant or expect to become pregnant during the course of the 
clinical trial will be excluded from participation in the clinical trial.  
All pregnancies that occur from the time of first administration of clinical trial treatment 
through study completion (Part 1 – Week 48 and Part 2 – Week 48 or Week 68) will be 
reported to the Sponsor. If clinical trial site staff become aware that a subject becomes 
pregnant after enrolling in the clinical trial, she will not be given any additional treatments 
with the IP. A Pregnancy Form will be completed by the PI and submitted to the Sponsor 
within 24 hours after becoming aware of the pregnancy. 
The PI will report this event to their IRB/REB/EC in accordance with their policies and 
procedures.  
The clinical trial site must request the subject’s permission to query the subject for 
outcome of the pregnancy. For participants who provide permission, the clinical trial site 
will follow-up with the study participant regarding outcome of the pregnancy and the 
neonate’s health out to 30 days post-delivery. The subject will continue to be followed for 
safety assessments without receiving additional IP until clinical trial discharge in 
accordance with this protocol. Procedures that are contraindicated during pregnancy, 
including additional treatments, must not be performed. The PI should use clinical 
judgment regarding subsequent clinical trial-related blood collection based on the 
presence or absence of anemia in each subject.  
Male participants will be instructed through the ICF to immediately inform the PI if their 
partner becomes pregnant until study completion. A Pregnancy Form will be completed 
by the PI and submitted to the Sponsor within 24 hours after becoming aware of the 
pregnancy. The pregnant partner will be asked to sign an Authorization for Use and 
Disclosure of Pregnancy Health Information to allow for follow-up on her pregnancy. If the 
authorization has been signed, the PI will update the Pregnancy Form with information on 
the pregnant partner’s health and the course and outcome of the pregnancy, including the 
neonate’s health out to 30 days post-delivery, and submit the form to the Sponsor.  
If a PI is contacted by the male subject or his pregnant partner, the PI may provide 
information on the risks of the pregnancy and the possible effects on the fetus to support 
an informed decision in cooperation with the treating physician and/or obstetrician. 
If the end of the pregnancy occurs after the clinical trial has been completed, the outcome 
will be reported directly to the Sponsor. 
All pregnancy information reported to Sponsor will be entered into the Sponsor’s safety 
database. 
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7.12 REPORTING DEVICE-RELATED COMPLAINTS OR DEFICIENCIES 
All product complaints that meet the definition of device deficiency must be reported to the 
Sponsor within 10 days of discovery, with the exception of SAEs which require 24-hour 
reporting. The error reporting or complaint form must be completed and emailed to 
the Sponsor at clinicalcomplaint@inovio.com. 
Device deficiencies include malfunctions, misuse or use errors and inadequate labeling. 
A malfunction is defined as the failure of a device to meet its performance specifications 
or otherwise perform as intended. The intended performance of a device refers to the 
intended use for which the device is labeled or marketed. 
Any problems experienced during the treatment procedure including potential 
malfunctions of the device, error messages displayed on the device screen following 
treatment, or errors that occur during the treatment procedure must immediately be 
reported to the Sponsor or its designee for evaluation.  
7.13 NOTIFYING REGULATORY AUTHORITIES AND INSTITUTIONAL REVIEW BOARDS
(IRBS)/RESEARCH ETHICS BOARDS (REBS)/ETHICS COMMITTEES (ECS) OF SAFETY
INFORMATION 
7.13.1 SPONSOR RESPONSIBILITIES 
•
Determine whether the safety information meets the requirements for expedited
reporting to the applicable regulatory authorities
•
Prepare and submit the safety report to the applicable regulatory authorities
•
Send all participating PIs a safety report and Investigator Safety Letter (i.e., Dear
Investigator Letter) that will include a statement if there is or is not any significant new
safety information that might influence the risk-benefit assessment of the IP and/or
study device, sufficient to consider changes in product administration or overall
conduct of the clinical investigation
7.13.2 PRINCIPAL INVESTIGATOR (PI) RESPONSIBILITIES 
•
Forward a copy of the safety report and Investigator Safety Letter (i.e., Dear
Investigator Letter) to their IRB/REB/EC as soon as practical in accordance with the
governing policy and/or procedures
•
Notify their IRB/REB/EC of safety information (i.e., SAEs, pregnancies and AESIs) that
occur at their clinical trial site in accordance with their local institutional policy
7.14 POST-TRIAL REPORTING REQUIREMENTS 
PIs are not obligated to actively seek AEs or SAEs beyond the clinical trial reporting period. 
However, if the PI becomes aware of an AE or SAE that occurs after the Completion or 
Termination Visit and the event is deemed by the PI to be probably or possibly related to 
the clinical trial treatment, the PI should promptly document and report the event to the 
Sponsor. Additionally, if the trial is discontinued for any reason (Section 7.15), all enrolled 
subjects still participating in the study will undergo the end of study evaluation prior to 
discontinuation from the study and any reported SAE or AESI will be followed by the PI 
until resolution or return to baseline status, or stabilization of the reported event (i.e., the 
expectation that it will remain chronic).   
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7.15 CLINICAL TRIAL DISCONTINUATION  
INOVIO reserves the right to discontinue the clinical trial at this site or at multiple sites for 
safety or administrative reasons at any time. In particular, a clinical trial site that does not 
recruit at a reasonable rate may be discontinued. Additionally, the clinical trial may be 
discontinued at any time by an IRB/REB/EC, INOVIO, or a regulatory authority as part of 
their duties to ensure that clinical trial participants are protected.  
If the clinical trial is discontinued and/or the clinical trial site closed for any 
reason, all IP and devices must be returned to INOVIO or its 
representative. The PI should ensure that their site file documents are complete 
prior to archiving, and provide copies of any requested documents to INOVIO 
for its Trial Master File (TMF). 
8.0 
STATISTICAL CONSIDERATIONS 
8.1 
STATISTICAL AND ANALYTICAL PLAN 
The documentation of the statistical and analytical plan is presented below. 
8.2 
GENERAL CONSIDERATIONS 
The statistical analysis of the data will be performed by Inovio Pharmaceuticals, or its 
representative. This is a randomized across Study Group, investigator-and-participant 
blinded, placebo-controlled (SSC-0001), multi-center phase 2a trial to evaluate the safety, 
tolerability and immunological profile of INO-4700 administered in healthy adult 
volunteers.  Approximately 542 volunteers will be evaluated across two (2) parts: Part 1 
Dose Finding and Part 2 Expansion.  
Approximately 192 participants in Part 1 will be randomized across each group (A through 
I; see Table 1) to receive either INO-4700 or placebo. Upon completion of the Week 10 
visit by all Part 1 participants including evaluable immunological data from all Study 
Groups, one optimal Study Group dose and regimen will be selected for expansion into 
Part 2. Participants in Part 1 will be followed until Week 48. 
Approximately 350 participants in Part 2 will be randomized to receive the optimal dose of 
INO-4700 or placebo (see Table 2). The first 225 participants randomized in parallel to 
three Study Groups will receive a third dose of either INO-4700 or placebo at Week 48. 
Participants will either receive a week 48 active treatment administration on top of their 
two prior active treatment administrations (N=100), or a week 48 placebo administration 
on top of their two prior active treatment administrations (N=100) or a week 48 placebo 
administration on top of two prior placebo administrations (N=25).  Collectively, these first 
225 participants will be followed until Week 68. The remaining 125 participants will be 
randomized in parallel to either 2 active treatment administrations (N=100) or 2 placebo 
administrations (N=25) and followed until Week 48.  
Details on the Study Group design and conduct and frequency of DMSB meetings can be 
found in Sections 3.0 and 12.1. 
The trial’s primary analyses pertains to the evaluation of the tolerability, safety and overall 
immune response to INO-4700 administered by ID injection followed by EP in healthy 
volunteers. Exploratory analyses concern the evaluation of the expanded immunological 
response to INO-4700 delivered by ID injection followed by EP, the cellular (T cell) and 
humoral immune response to boosting with a third INO-4700 ID injection followed by EP 
and the evaluation of the cross reactivity of other coronavirus spike proteins to the humoral 
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immune response to the MERS-CoV spike protein after receipt of the INO-4700 ID 
injection followed by EP.  
8.3 
STATISTICAL HYPOTHESES 
No formal statistical hypothesis will be tested in Part 1 of this trial. The hypothesis in Part 
2 of this trial is H0: p ≤ 70% versus H1: p > 70%, where p denotes the true population 
overall immunological response rate for the selected optimal dose of INO-4700. 
8.4 
ANALYTICAL POPULATIONS 
Analysis populations will be: 
The modified intention to treat (mITT) population includes all participants who receive at 
least one dose of the INO-4700 or placebo. Participants in this sample will be analyzed by 
their original assigned dose of INO-4700 or placebo. The mITT population will be used to 
analyze co-primary and exploratory immunological endpoints. 
The per-protocol (PP) population is comprised of mITT participants who receive all their 
planned administrations and who have no Medical Monitor-assessed important protocol 
violations. Analyses on the PP population will be considered supportive of the 
corresponding mITT analyses. Participants excluded from the PP population will be 
identified and documented prior to locking the study database. 
The safety analysis population includes all participants who receive at least one dose of 
INO-4700 or placebo administered by ID injection. Participants for this population will be 
grouped in accordance with the dose of INO-4700 or placebo that they received. This 
population will be used for all safety analyses in the study. 
8.5 
DESCRIPTION OF STATISTICAL METHODS 
8.5.1 
PRIMARY SAFETY ANALYSES 
The primary analyses for this trial are safety analyses of treatment emergent adverse 
events (TEAEs), administration site reactions and clinically significant changes in safety 
laboratory parameters from baseline.   
TEAEs are defined for this trial as any AEs/AESIs/SAEs that occur on or after Day 0 
following IP administration. All TEAEs will be summarized by frequency, percentage and 
associated 95% Clopper-Pearson confidence interval, and in Part 2, the difference in the 
percentage between those who received INO-4700 and their corresponding same 
regimen placebo together with associated 95% confidence interval. Related SAEs and 
related Grade 3 or higher AEs will also be analyzed as described above within and 
between associated placebo in part 1. The frequencies will also be presented separately 
by dose number and will be depicted by system order class and preferred term. Additional 
frequencies will be presented with respect to maximum severity and relationship to IP. 
Multiple occurrences of the same AE in a single subject will be counted only once following 
a worst-case approach with respect to severity and relationship to IP. All serious TEAEs 
will also be summarized as above. AE duration will be calculated as AE stop date – AE 
start date + 1 day. AEs and SAEs that are not TEAEs or serious TEAEs will be presented 
in listings. 
All of these primary safety analyses will be conducted on the participants in the safety 
population. 
8.5.2 
PRIMARY IMMUNOGENICITY ANALYSES 
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For both Part 1 and Part 2, antigen specific binding antibody titers, MERS-CoV neutralizing 
antibody titers, and specific cellular immune responses will be analyzed by Study Group.   
Binding antibody titer will be analyzed for each Study Group using the geometric mean 
and associated 95% confidence intervals. Percent neutralizing antibodies and antigen 
specific cellular immune response increases will be analyzed for each Study Group using 
medians, inter-quartile range and 95% confidence intervals. Percentage with overall 
immune response, inclusive of seroconversion (i.e., positive titer), and corresponding 95% 
Clopper-Pearson confidence intervals will be analyzed within each Study Group.   
In Part 1, the difference in percentage of overall immune responders including 
seroconverters between all pairs of INO-4700 Study Groups will be calculated along with 
corresponding exact 95% confidence intervals. 
In Part 2, the primary hypothesis of H0: p ≤ 70% versus H1: p > 70% will be tested with 
an exact test of a binomial proportion.  In addition, the binding antibody titer difference 
between INO-4700 and placebo will be analyzed using the geometric mean fold ratio and 
associated 95% confidence interval. Percent neutralizing antibodies and antigen specific 
cellular immune response differences between INO-4700 and placebo will be analyzed 
using the difference in medians and associated 95% confidence intervals. 
All of these primary immunogenicity analyses will be conducted on the participants in the 
mITT and PP populations. 
8.5.3 
SAFETY ANALYSES 
Laboratory response variables will be descriptively summarized in accordance with time 
point and as changes from baseline including 95% confidence intervals. Laboratory values 
considered clinically significant will be presented in listings for participants in the safety 
population. 
Measurements for vital signs as well as changes from baseline will be descriptively 
summarized by time point for participants in the safety population.   
Serum pregnancy at Screening and urine pregnancy at each post baseline time point will 
be descriptively summarized for participants in the safety population.  
The percentage of participants with abnormal medical history findings will be summarized 
by body system and preferred term for participants in the safety and mITT populations.   
For statistical analysis purposes, prior medications are defined as those that were used 
and stopped before the start of the trial (prior to Day 0) and concomitant medications are 
defined as those used during the course of trial (on or after Day 0). Partial stop dates of 
prior and concomitant medications will be assumed to be the latest possible date 
consistent with the partial date. Data for all prior and concomitant medications will be 
summarized with percentages for participants in the safety and mITT populations.  
8.5.4 
DISPOSITION 
Subject disposition will be summarized for all randomized participants and will include the 
number and percentage randomized, the number and percentage who received each 
planned dose and the number who completed each part of the trial. The number and 
percentage of participants who discontinued IP in each part of the trial will be summarized 
overall and by reason. The number in each analysis population will also be presented. 
8.5.5 
DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS 
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Demographic and baseline characteristic data will be descriptively summarized for 
participants in the safety and mITT populations.  
8.5.6 
INTERIM ANALYSES  
No formal interim analyses will be performed for this trial. However, safety and tolerability 
will be assessed by the DSMB as noted above for the participants in each Study Group.   
A Sponsor unblinded review of the week 10 immunogenicity and safety data will be made 
during Part 1 of this study when all evaluable data observations are available in order to 
determine the optimal dose for the Part 2 of the study. The selection of the optimal dose 
for Part 2 will involve consideration of weighted ordered criteria described in Figure 3 
below.   
Figure 3: Weighted Ordered Dose Selection Criteria 
 
At a minimum, the optimal selected dose will have a 70% overall immune response and 
acceptable safety profile as determined by the DSMB and Inovio Medical Council. Other 
criteria listed in Figure 3 will contribute to the selection of the right optimal dose if the 
overall immune responses and safety profiles are similar between the Study Groups in 
Part 1.     
A group-level unblinded review of the immunogenicity and safety data will be made once 
week 12 visit  data are complete for all participants in Part 2 whilst maintaining subject-
level blinding. Long-term follow-up data will continue to be collected for all participants 
with remaining visits through to the final visit. These summaries and analyses will allow 
the Sponsor and collaborators to have results with respect to the immunogenicity and 
safety endpoints up to and including the Part 2 Week 12 visit on which to inform product 
development goals. No subject-level immunogenicity data will be produced and subject-
level immunogenicity data will not be available in the clinical trial database until all other 
clinical trial data are finalized at the end of the trial. Thus, Part 2 of the trial will remain 
blinded to the Sponsor and collaborators with respect to subject treatment assignment. 
In order to protect the blind, for the group-level unblinded review, no safety analysis will 
be provided if the total of subjects who experience the event of interest is greater than 0 
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and the count of these events relative to the total count of events produces a percentage 
less than 3% for a given analysis. 
8.5.7 
MULTIPLICITY 
No adjustment for multiplicity will be made for this trial. 
8.5.8 
MISSING VALUES 
Missing data will not be imputed or replaced, and calculations will be done on reported 
values. 
8.5.9 
EXPLORATORY ANALYSES  
T and B post baseline cell number will be analyzed descriptively by Study Group using the 
mean or median and associated 95% confidence intervals. 
In Part 2, treatment difference comparisons will include a comparison of two dose INO-
4700 participants who are boosted with INO-4700 versus two dose INO-4700 participants 
who are boosted with placebo.  
Exploratory ANCOVA and Logistic models may be fit that include baseline, confounder 
variables such as age, antibodies to other coronaviruses and gender to test the 
relationship between study group and different immune response variables.  The 
relationship between antibodies to other coronaviruses and humoral immune responses 
will be explored using regression methods such as linear regression. 
8.6 
SAMPLE SIZE/POWER 
No formal power analysis is applicable to Part 1 of this trial, as descriptive statistics will be 
used to summarize the data. 
For each Study Group in Part 1 of the trial with 32 INO-4700 administered participants, 
the study provides 95% confidence that the true incidence of SAEs is <11% if no SAEs 
are observed in a study group. For all the Study Groups combined in Part 1 of the trial with 
160 INO-4700 administered participants, the study provides 95% confidence that the true 
incidence of SAEs is <3% if no SAEs are observed in this study phase. For all Study 
Groups combined across Parts 1 & 2 of the trial with 460 INO-4700 administered 
participants, the study provides 95% confidence that the true incidence of SAEs is <1% if 
no SAEs are observed. 
For Part 2 of this trial, an evaluable sample of 260 active subjects treated with INO-4700, 
which will be used for formal hypothesis testing, provides >90% power to detect an INO-
4700 overall immunological response rate of 70% or higher should this overall response 
rate truly be 80%, using a one-sided type 1 error rate of 0.025.  
8.7 
RANDOMIZATION AND BLINDING  
Part 1 of this study will be randomized across Study Groups (A through I). Part 2 of this 
study will be randomized between the selected optimal Active dose from Part 1 and 
placebo groups. The study is Investigator-and-participant blinded except for the site 
pharmacy across all Study Groups for both parts of the study. The Sponsor will be blinded 
in Part 1 until Week 10 and blinded for the entire duration of Part 2 of the study.   
For the Part 2 Week 12 analysis, group level unblinded summaries of immunogenicity and 
safety will be produced. The Sponsor will continue to remain blinded to subject-level 
treatment allocation for the remainder of the trial.    
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9.0 
ETHICS 
9.1 
INVESTIGATOR AND SPONSOR RESPONSIBILITIES 
The Investigator and Sponsor are responsible for ensuring that the clinical trial is 
performed in accordance with the protocol, the principles of the Declaration of Helsinki, 
Good Clinical Practice (GCP) and applicable regulatory requirements. 
9.2 
INSTITUTIONAL REVIEW BOARD (IRB)/RESEARCH ETHICS BOARD (REB)/ETHICS 
COMMITTEE (EC) 
The Investigator will commence the clinical trial after full approval of the protocol and 
adjunctive materials (e.g., ICF, advertising) has been obtained from the applicable 
IRB/REB/EC and a copy of IRB/REB/EC approval documentation has been received by 
the Sponsor. 
Investigator responsibilities relevant to the IRB/REB/EC include the following: 
• Submit progress reports to the IRB/REB/EC as required, and request re-review 
and approval of the clinical trial at least once a year during the conduct of the 
clinical trial 
• Notify the Sponsor immediately of any suspected unexpected adverse drug or 
device events/effects 
• Notify the IRB/REB/EC immediately if the Sponsor notifies the Investigator about 
any reportable safety events 
• Obtain approval from the IRB/REB/EC for protocol amendments and for revisions 
to the consent form or participant recruitment advertisements, as required 
• Submit reports on, and reviews of, the clinical trial and its progress to the 
IRB/REB/EC at intervals stipulated in their guidelines and in accordance with 
pertinent regulations and guidelines 
• Maintain a file of clinical trial-related information (refer to clinical trial files) that 
includes all correspondence with the IRB/REB/EC 
• Notify the IRB/REB/EC when the clinical trial is completed (i.e., after the last clinical 
trial visit of the final clinical trial subject) 
• After clinical trial completion (within three [3] months is recommended), provide the 
IRB/REB/EC with a final report on the clinical trial 
Institutional Biosafety Committee (IBC), if applicable 
The Investigator will undertake the trial after full approval of the protocol and adjunctive 
materials (e.g., pharmacy manual) has been obtained from the applicable IBC and a copy 
of this approval has been received by the Sponsor. 
Investigator responsibilities relevant to the IBC include the following: 
• 
Notify the Sponsor, IBC and NIH OSP within 30 days of any: 
o Substantial problems or violation of the NIH Guidelines 
o Significant research related accidents or illnesses 
• 
Notify the IBC to any changes to the research (dosage, procedure, etc.) or facility 
(new space, remodeling, etc.).   
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9.3 
PROTECTION OF HUMAN PARTICIPANTS 
9.3.1 COMPLIANCE WITH INFORMED CONSENT REGULATIONS 
Written informed consent must be obtained from each subject, and/or from the subject’s 
legally authorized representative, prior to the subject’s enrollment in the clinical trial. The 
process for obtaining informed consent must be documented in the subject’s medical 
record (also refer to Section 6.2). 
9.3.2 COMPLIANCE WITH INSTITUTIONAL REVIEW BOARD (IRB)/RESEARCH ETHICS BOARD 
(REB)/ETHICS COMMITTEE (EC) REQUIREMENTS 
This clinical trial is to be conducted in accordance with applicable IRB/REB/EC 
regulations. The Investigator must obtain approval from a properly constituted 
IRB/REB/EC prior to initiating the clinical trial and obtain re-approval or review at least 
annually. The Sponsor is to be notified immediately if the responsible IRB/REB/EC has 
been disqualified or if proceedings leading to disqualification have begun. Copies of all 
IRB/REB/EC correspondence with the Investigator should be provided to the Sponsor. 
9.3.3 COMPLIANCE WITH GOOD CLINICAL PRACTICE 
This protocol is to be conducted in accordance with the applicable GCP regulations and 
guidelines. 
9.3.4 
COMPLIANCE WITH ELECTRONIC RECORDS/SIGNATURES REGULATIONS (21CFR 
PART 11) 
When applicable, this clinical trial is to be conducted in compliance with the regulations on 
electronic records and electronic signature. 
9.3.5 COMPLIANCE WITH PROTOCOL 
Participants are not required to follow special instructions specific to the IP used in this 
clinical trial. Participants will be provided with Investigator emergency contact information 
and advised to report all AEs. While every effort should be made to avoid protocol 
deviations, should an important deviation be discovered, the Sponsor must be informed 
immediately. Any protocol deviation impacting subject safety must be reported to the 
Medical Monitor immediately. 
9.3.6 CHANGES TO THE PROTOCOL 
The Investigator should not implement any deviation from, or changes to, the protocol 
without Sponsor approval and prior review and documented approval/favorable opinion of 
the protocol amendment from the IRB/REB/EC, except where necessary to eliminate 
immediate hazards to clinical trial participants, or when the changes involve only logistical 
or administrative aspects of the clinical trial (e.g., change in monitors, change of telephone 
numbers).  
10.0 DATA COLLECTION, MONITORING AND REPORTING 
10.1 CONFIDENTIALITY AND PRIVACY 
A report of the results of this clinical trial may be published or sent to the appropriate 
regulatory authorities in any country in which the clinical trial products are legally marketed 
or may ultimately be marketed, but the subject’s name/identity will not be disclosed in 
these documents. The clinical trial Sponsor, its agents, the IRB/REB/EC and regulatory 
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authorities will have direct access to the participants medical records for the purposes of 
trial-related monitoring, auditing and inspection. Appropriate precautions will be taken to 
maintain confidentiality of medical records and personal information. 
Written Authorization and other documentation are to be obtained from each subject, 
and/or from the subject’s legally authorized representative, prior to enrollment in the 
clinical trial, in accordance with all applicable laws, regulations and/or directives relating 
to privacy and data protection. 
11.0 SOURCE DOCUMENTS 
Source data is all information, electronic or hardcopy original records or clinical findings, 
laboratory results, observations, or other activities in a clinical trial necessary for the 
reconstruction and evaluation of the clinical trial. 
Examples of original source data records may include:  
• Hospital records 
• Clinical and office charts 
• Laboratory notes 
• Memoranda 
• Pharmacy dispensing records 
• Recorded data from automated instruments 
• Copies of electronic medical records (EMR) certified after verification as being 
accurate and complete 
• X-rays 
• Subject files and records kept at the pharmacy, at the laboratories, at the medical 
records facility and within information technology (IT) systems that are involved in 
the clinical trial  
This clinical trial will utilize an eSource system.  In most cases, sites will document source 
data directly in eSource.  However, there will be circumstances where source data will 
exist in paper records, (e.g. laboratory reports, informed consent and previous medical 
history records. 
The Investigator/institution will permit clinical trial-related monitoring, audits, IRB/REB/EC 
review and regulatory inspections by providing direct access to source data/documents 
related to this clinical trial. 
11.1 RECORDS RETENTION 
Upon request of the Clinical Monitor, Sponsor or its agent(s), auditor, IRB/REB/EC or 
regulatory authority, the Investigator/institution should make available for direct access all 
requested clinical trial-related records. 
CRFs will be provided for each subject. Participants must not be identified by name on 
any CRFs. Participants will be identified by their subject identification number (SID). 
It is the Investigator’s responsibility to retain clinical trial essential documents for at least 
two (2) years after the last approval of a marketing application in their country and until 
there are no pending or contemplated marketing applications in their country or at least 
two (2) years have elapsed since the formal discontinuation of clinical development of the 
IP. This retention period may be superseded by local requirements. The Sponsor will 
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inform the Investigator/institution when these documents are no longer needed to be 
retained. 
If the Records Retention requirements are addressed in a governing clinical trial 
agreement, it is the Investigator’s responsibility to retain clinical trial essential documents 
in accordance with the governing clinical trial agreement and applicable local 
requirements. 
12.0 SAFETY AND QUALITY MONITORING 
12.1 SAFETY REVIEW 
The Sponsor’s Medical Monitor will regularly review safety and tolerability data throughout 
the trial in a blinded fashion until unblinding. Additional safety reviews will be conducted 
by a DSMB, and they will be responsible for reviewing all unblinded safety data, including 
AEs of clinical significance, AESIs and SAEs, as well as safety laboratory data. Safety 
reviews will include data from all enrolled participants. 
The DSMB is not blinded to IP allocation and will review unblinded safety data. The DSMB 
will be charged with advising whether there appears to be any safety concerns and to 
make recommendations regarding continued enrollment, trial pause and trial suspension. 
If the safety data is considered unsatisfactory during any safety review, the study may be 
paused or stopped. In this case, further enrollment and administration of INO-4700 or 
placebo to participants will be paused for further evaluation. The Sponsor will perform an 
investigation and consult the DSMB and other experts, if needed, to determine whether to 
resume randomization and/or dosing of the remainder of the participants. For further 
details see DSMB Charter.  
12.2 CLINICAL MONITORING 
Clinical Monitoring will be performed by qualified Clinical Monitors who will report to the 
Sponsor or the Sponsor’s designee. Records for all clinical trial participants in this clinical 
trial will be monitored. The following clinical trial site monitoring tasks will be performed at 
all clinical trial sites: 
• 
Prior to subject screening at the site, a Site Initiation Visit will be conducted to 
review all relevant forms and documentation, and ensure that the clinical trial site 
staff are qualified and compliant with all applicable requirements 
• 
All clinical trial site monitoring visits will be documented 
• 
Periodic clinical trial site visits will be performed throughout the clinical trial 
• 
The blinded Clinical Monitor will address and document the following trial conduct 
activities and obligations: 
o Assure that the trial is being conducted in accordance with the protocol, 
applicable regulatory agency regulations, and IRB/REB/EC policies. 
o Discuss trial conduct issues and incidents of noncompliance with the 
Investigator and/or trial personnel and document them on the resolution trip 
report. Report any significant unresolved problems immediately to the 
Sponsor. 
o Remind the Investigator as necessary of the obligation to immediately report 
all SAE and provide subsequent follow-up report of the final outcome to the 
IRB. 
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o Throughout the trial, inspect all source documents to ensure they are complete, 
logical, consistent, attributable, legible, contemporaneous, original, and 
accurate (ALCOA). 
o Assure that the trial facilities continue to be acceptable. 
o Compare the trial CRFs with source documents to assure that the data are 
accurate and complete and that the protocol is being followed. 
o Assure that investigational device accountability and reconciliation of records 
are complete and accurate. 
o Assure that all subject specimens are being stored and forwarded properly for 
testing in accordance with laboratory manual requirements. 
• 
The unblinded Clinical Monitor will address and document the following trial 
conduct activities and obligations: 
o Assure that the trial is being conducted in accordance with the protocol, 
applicable regulatory agency regulations, and IRB/REB/EC policies. 
o Discuss trial conduct issues and incidents of noncompliance with the 
Investigator and/or trial personnel while maintaining the blind and document 
them on the resolution trip report. Report any significant unresolved problems 
immediately to the Sponsor while maintaining the blind. 
o Throughout the trial, inspect all source documents to ensure they are complete, 
logical, consistent, attributable, legible, contemporaneous, original, and 
accurate (ALCOA). 
o Assure that the pharmacy continues to be acceptable. 
o Assure that investigational drug accountability and reconciliation of records are 
complete and accurate. 
13.0 FINANCING AND INSURANCE 
Inovio Pharmaceuticals is the Sponsor and is fully supporting the study with funding 
provided by the Coalition for Epidemic Preparedness Innovations (CEPI). Clinical trial 
insurance has been taken out according to the laws of the countries where the study will 
be conducted. The investigative site is being compensated for the conduct of this study 
and will follow the terms described in the clinical trial agreement. This agreement was 
executed separately from this clinical trial protocol. The Investigators will be required to 
provide full financial disclosure information per 21 CFR Part 54, ICH E6 and/or local 
regulations, where applicable. 
14.0 PUBLICATION POLICY 
Publication of the results of this clinical trial in its entirety will be allowed. The proposed 
presentation, abstract and/or manuscript must be made available to the Sponsor for 
review and approval in accordance with the governing clinical trial agreement. 
 
 
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15.0 LIST OF ABBREVIATIONS 
ADE 
Adverse Device Effect 
ADR 
Adverse Drug Reaction 
AE 
Adverse Event 
AESI 
Adverse Event of Special Interest 
ALCOA 
Attributable, Legible, Contemporaneous, Original, and Accurate 
bGH polyA 
Bovine growth hormone 3’ end poly-adenylation signal 
BP 
Blood Pressure 
BUN 
Blood Urea Nitrogen 
Ca 
Calcium 
CBC 
Complete Blood Count 
CEPI 
Coalition for Epidemic Preparedness Innovations 
Cl 
Chloride 
CO2 
Carbon Dioxide 
Cr 
Creatinine 
CRF 
Case Report Form 
CS 
Clinically Significant 
DNA 
Deoxyribonucleic Acid 
DSMB 
Data Safety Monitoring Board 
EC 
Ethics Committee 
ECG 
Electrocardiogram 
EDC 
Electronic Data Capture 
EP 
Electroporation 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HBsAg 
Hepatitis B Surface Antigen 
HCO3 
Biocarbonate 
hCMV  
Human CMV 
HCV 
Hepatitis C Virus 
HIV 
Human Immunodeficiency Virus 
IB 
Investigator’s Brochure 
ICD 
Implantable-Cardioverter-defibrillator 
ICF 
Informed Consent Form 
ICH 
International Council on Harmonization 
ID 
Intradermal 
IM 
Intramuscular 
INOVIO 
Inovio Pharmaceuticals Inc. 
IP 
Investigational Product 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
K 
Potassium 
KanR 
Kanamycin resistance gene 
mITT 
modified Intent to Treat 
MM 
Medical Monitor 
MERS 
Middle East Respiratory Syndrome  
MERS-CoV 
Middle East Respiratory Syndrome Coronavirus 
mRNA 
Messenger RNA 
Na 
Sodium 
NCS 
Not Clinically Significant 
NIAID 
National Institute for Allergy and Infectious Disease 
NHP 
Non-human Primates 
PHI 
Personal Health Information 
PI 
Principal Investigator 
PII 
Personal Identifying Information 
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Page 68 of 75 
 
PO4 
Potassium 
PT 
Preferred Term 
pUC ori 
Plasmid origin of replication 
RBC 
Red blood cell 
REB 
Research Ethics Board 
RR 
Respiratory Rate 
SAE 
Serious Adverse Event 
SARS 
Severe Acute Respiratory Syndrome  
SARS-CoV 
Severe Acute Respiratory Syndrome coronavirus 
SID 
Subject Identification Number 
SOC 
System Organ Class 
SSC 
Saline Sodium Citrate 
SynCon 
Synthetic consensus 
TMF 
Trial Master File 
UADE 
Unanticipated Adverse Device Effect 
WBC 
White blood cell 
WHO 
World Health Organization 
WOCBP 
Women of Child Bearing Potential 
 
 
 
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16.0 REFERENCES 
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Chan RW, Hemida MG, Kayali G, Chu DK, Poon LL, Alnaeem A, et al. Tropism and
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Chan JF, Choi GK, Tsang AK, Tee KM, Lam HY, Yip CC, et al. Development and
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Ramadan N, Shaib H. Middle East respiratory syndrome coronavirus (MERS-CoV): A
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Inovio Pharmaceuticals, Inc. 
 
Clinical Protocol 
Protocol Version Date: 12Feb2021 
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Page 70 of 75 
 
19. 
Park WB, Perera RA, Choe PG, Lau EH, Choi SJ, Chun JY, et al. Kinetics of Serologic 
Responses to MERS Coronavirus Infection in Humans, South Korea. Emerg Infect Dis 
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Payne DC, Iblan I, Rha B, Alqasrawi S, Haddadin A, Al Nsour M, et al. Persistence of 
Antibodies against Middle East Respiratory Syndrome Coronavirus. Emerg Infect Dis 
2016,22:1824-1826. 
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Falzarano D, de Wit E, Rasmussen AL, Feldmann F, Okumura A, Scott DP, et al. 
Treatment with interferon-alpha2b and ribavirin improves outcome in MERS-CoV-infected 
rhesus macaques. Nat Med 2013,19:1313-1317. 
22. 
Omrani AS, Saad MM, Baig K, Bahloul A, Abdul-Matin M, Alaidaroos AY, et al. Ribavirin 
and interferon alfa-2a for severe Middle East respiratory syndrome coronavirus infection: 
a retrospective cohort study. Lancet Infect Dis 2014,14:1090-1095. 
23. 
Pascal KE, Coleman CM, Mujica AO, Kamat V, Badithe A, Fairhurst J, et al. Pre- and 
postexposure efficacy of fully human antibodies against Spike protein in a novel 
humanized mouse model of MERS-CoV infection. Proc Natl Acad Sci U S A 
2015,112:8738-8743. 
24. 
Agrawal AS, Garron T, Tao X, Peng BH, Wakamiya M, Chan TS, et al. Generation of a 
transgenic mouse model of Middle East respiratory syndrome coronavirus infection and 
disease. J Virol 2015,89:3659-3670. 
25. 
Modjarrad K. MERS-CoV vaccine candidates in development: The current landscape. 
Vaccine 2016,34:2982-2987. 
26. 
Mubarak A, Alturaiki W, Hemida MG. Middle East Respiratory Syndrome Coronavirus 
(MERS-CoV): Infection, Immunological Response, and Vaccine Development. J Immunol 
Res 2019,2019:6491738. 
27. 
Almazan F, DeDiego ML, Sola I, Zuniga S, Nieto-Torres JL, Marquez-Jurado S, et al. 
Engineering a replication-competent, propagation-defective Middle East respiratory 
syndrome coronavirus as a vaccine candidate. MBio 2013,4:e00650-00613. 
28. 
Zhang N, Tang J, Lu L, Jiang S, Du L. Receptor-binding domain-based subunit vaccines 
against MERS-CoV. Virus Res 2015,202:151-159. 
29. 
Ma C, Li Y, Wang L, Zhao G, Tao X, Tseng CT, et al. Intranasal vaccination with 
recombinant receptor-binding domain of MERS-CoV spike protein induces much stronger 
local mucosal immune responses than subcutaneous immunization: Implication for 
designing novel mucosal MERS vaccines. Vaccine 2014,32:2100-2108. 
30. 
Modjarrad K, Roberts CC, Mills KT, Castellano AR, Paolino K, Muthumani K, et al. Safety 
and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA 
vaccine: a phase 1, open-label, single-arm, dose-escalation trial. Lancet Infect Dis 
2019,19:1013-1022. 
31. 
Muthumani K, Falzarano D, Reuschel EL, Tingey C, Flingai S, Villarreal DO, et al. A 
synthetic consensus anti-spike protein DNA vaccine induces protective immunity against 
Middle East respiratory syndrome coronavirus in nonhuman primates. Sci Transl Med 
2015,7:301ra132. 
32. 
World Health Organization. MERS Monthly Summary, April 2019. In; 2019. 
33. 
World Health Organization. Middle East Respiratory Syndrome Coronavirus (MERS-CoV) 
Summary of Current Situation, August 2018. In; 2018. 
34. 
Cauchemez S, Fraser C, Van Kerkhove MD, Donnelly CA, Riley S, Rambaut A, et al. 
Middle East respiratory syndrome coronavirus: quantification of the extent of the epidemic, 
surveillance biases, and transmissibility. Lancet Infect Dis 2014,14:50-56. 
35. 
Coalition for Epidemic Preparedness Innovations. Priority Diseases. In. 
36. 
World Health Organization. WHO consultation on MERS-CoV therapeutics and vaccine 
evaluation. In. Geneva, Switzerland; 2018. 
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Clinical Protocol 
Protocol Version Date: 12Feb2021 
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37.
Morrow MP, Tebas P, Yan J, Ramirez L, Slager A, Kraynyak K, et al. Synthetic Consensus
HIV-1 DNA Induces Potent Cellular Immune Responses and Synthesis of Granzyme B,
Perforin in HIV Infected Individuals. Mol Ther 2015,23:591-601.
38.
Trimble CL, Morrow MP, Kraynyak KA, Shen X, Dallas M, Yan J, et al. Safety, efficacy,
and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human
papillomavirus 16 and 18 E6 and E7 proteins for cervical intraepithelial neoplasia 2/3: a
randomised, double-blind, placebo-controlled phase 2b trial. Lancet 2015,386:2078-2088.
39.
Tebas P, Kraynyak KA, Patel A, Maslow JN, Morrow MP, Sylvester AJ, et al. Intradermal
SynCon® Ebola GP DNA Vaccine is Temperature Stable and Safely Demonstrates
Cellular and Humoral Immunogenicity Advantages in Healthy Volunteers. J Infect Dis
2019.
40.
Tebas P, Roberts CC, Muthumani K, Reuschel EL, Kudchodkar SB, Zaidi FI, et al. Safety
and Immunogenicity of an Anti-Zika Virus DNA Vaccine - Preliminary Report. N Engl J
Med 2017.
41.
HVTN Full Group Meeting Washington D.C. In; 2017.
42.
Choe PG, Perera R, Park WB, Song KH, Bang JH, Kim ES, et al. MERS-CoV Antibody
Responses 1 Year after Symptom Onset, South Korea, 2015. Emerg Infect Dis
2017,23:1079-1084.
43.
Alshukairi AN, Khalid I, Ahmed WA, Dada AM, Bayumi DT, Malic LS, et al. Antibody
Response and Disease Severity in Healthcare Worker MERS Survivors. Emerg Infect Dis
2016,22.
44.
World Health Organization. WHO Target Product Profiles for MERS-CoV Vaccines. In:
WHO; 2017.
45.
Suschak JJ, Williams JA, Schmaljohn CS. Advancements in DNA vaccine vectors, non-
mechanical delivery methods, and molecular adjuvants to increase immunogenicity. Hum
Vaccin Immunother 2017,13:2837-2848.
46.
Manickan E, Karem KL, Rouse BT. DNA Vaccines - A Modern Gimmick or a Boon to
Vaccinology? Crit Rev Immunol 2017,37:483-498.
47.
Porter KR, Raviprakash K. DNA Vaccine Delivery and Improved Immunogenicity. Curr
Issues Mol Biol 2017,22:129-138.
48.
Li L, Petrovsky N. Molecular mechanisms for enhanced DNA vaccine immunogenicity.
Expert Rev Vaccines 2016,15:313-329.
49.
Marc MA, Dominguez-Alvarez E, Gamazo C. Nucleic acid vaccination strategies against
infectious diseases. Expert Opin Drug Deliv 2015,12:1851-1865.
50.
Grunwald T, Ulbert S. Improvement of DNA vaccination by adjuvants and sophisticated
delivery devices: vaccine-platforms for the battle against infectious diseases. Clin Exp
Vaccine Res 2015,4:1-10.
51.
Tregoning JS, Kinnear E. Using Plasmids as DNA Vaccines for Infectious Diseases.
Microbiol Spectr 2014,2.
52.
Williams JA. Improving DNA vaccine performance through vector design. Curr Gene Ther
2014,14:170-189.
53.
Liu MA. DNA vaccines: an historical perspective and view to the future. Immunol Rev
2011,239:62-84.
54.
Wahren B, Liu MA. DNA Vaccines: Recent Developments and the Future. Vaccines
(Basel) 2014,2:785-796wahren.
55.
Ledgerwood JE, Graham BS. DNA vaccines: a safe and efficient platform technology for
responding to emerging infectious diseases. Hum Vaccin 2009,5:623-626.
56.
Keefer MC, Graham BS, Belshe RB, Schwartz D, Corey L, Bolognesi DP, et al. Studies of
high doses of a human immunodeficiency virus type 1 recombinant glycoprotein 160
candidate vaccine in HIV type 1-seronegative humans. The AIDS Vaccine Clinical Trials
Network. AIDS Res Hum Retroviruses 1994,10:1713-1723.
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Protocol Version Date: 12Feb2021 
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57. 
Martin JE, Sullivan NJ, Enama ME, Gordon IJ, Roederer M, Koup RA, et al. A DNA vaccine 
for Ebola virus is safe and immunogenic in a phase I clinical trial. Clin Vaccine Immunol 
2006,13:1267-1277. 
58. 
Prud'homme GJ, Glinka Y, Khan AS, Draghia-Akli R. Electroporation-enhanced nonviral 
gene transfer for the prevention or treatment of immunological, endocrine and neoplastic 
diseases. Curr Gene Ther 2006,6:243-273. 
59. 
Hirao LA, Wu L, Khan AS, Hokey DA, Yan J, Dai A, et al. Combined effects of IL-12 and 
electroporation enhances the potency of DNA vaccination in macaques. Vaccine 
2008,26:3112-3120. 
60. 
Rosati M, Valentin A, Jalah R, Patel V, von Gegerfelt A, Bergamaschi C, et al. Increased 
immune responses in rhesus macaques by DNA vaccination combined with 
electroporation. Vaccine 2008,26:5223-5229. 
61. 
Curcio C, Khan AS, Amici A, Spadaro M, Quaglino E, Cavallo F, et al. DNA immunization 
using constant-current electroporation affords long-term protection from autochthonous 
mammary carcinomas in cancer-prone transgenic mice. Cancer Gene Ther. 2008,15:108-
114. 
62. 
Ugen KE, Kutzler MA, Marrero B, Westover J, Coppola D, Weiner DB, et al. Regression 
of subcutaneous B16 melanoma tumors after intratumoral delivery of an IL-15-expressing 
plasmid followed by in vivo electroporation. Cancer Gene Ther. 2006,13:969-974. 
63. 
Kahwati LC, Haigler L, Rideout S, Markova T. What is the best way to diagnose 
menopause? J Fam Pract 2005,54:1000-1002. 
64. 
Sarri G, Davies M, Lumsden MA, Guideline Development G. Diagnosis and management 
of menopause: summary of NICE guidance. BMJ 2015,351:h5746. 
 
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17.0 APPENDICES 
17.1 APPENDIX A: TOXICITY GRADING SCALE FOR HEALTHY ADULT AND ADOLESCENT 
VOLUNTEERS ENROLLED IN PREVENTIVE VACCINE CLINICAL TRIAL  
Table for Clinical Abnormalities 
Local Reaction to 
Injectable Product 
Mild (Grade 1) 
Moderate (Grade 
2) 
Severe (Grade 3) 
Potentially Life 
Threatening 
(Grade 4) 
Pain 
Does not interfere 
with activity 
Repeated use of 
non-narcotic pain 
reliever > 24 hours 
or interferes with 
activity 
Any use of 
narcotic pain 
reliever or 
prevents daily 
activity 
Emergency 
room (ER) visit 
or 
hospitalization 
Tenderness 
Mild discomfort to 
touch 
Discomfort with 
movement 
Significant 
discomfort at rest 
ER visit or 
hospitalization 
Erythema/Rednessa 
2.5-5 cm 
5.1-10 cm 
> 10 cm 
Necrosis or 
exfoliative 
dermatitis 
Induration/Swellingb 
2.5-5 cm and 
does not interfere 
with activity 
5.1-10 cm or 
interferes with 
activity 
> 10 cm or 
prevents daily 
activity 
Necrosis 
Vital Signsc 
Mild (Grade 1) 
Moderate (Grade 
2) 
Severe (Grade 3) 
Potentially Life 
Threatening 
(Grade 4) 
Fever   (°C)d 
            (°F)d 
38.0-38.4 
100.4-101.1 
38.5-38.9 
101.2-102.0 
39.0-40.0 
102.1-104.0 
> 40.0 
> 104.0 
Tachycardia - beats 
per minute 
101-115 
116-130 
> 130 
ER visit or 
hospitalization 
for arrhythmia 
Bradycardia - beats 
per minutee 
50-54 
45-49 
< 45 
ER visit or 
hospitalization 
for arrhythmia 
Hypertension 
(systolic) - mm Hg 
141-150 
151-155 
> 155 
ER visit or 
hospitalization 
for malignant 
hypertension 
Hypertension 
(diastolic) - mm Hg 
91-95 
96-100 
> 100 
ER visit or 
hospitalization 
for malignant 
hypertension 
Hypotension 
(systolic) - mm Hg 
85-89 
80-84 
< 80 
ER visit or 
hospitalization 
for hypotensive 
shock 
Respiratory Rate - 
breaths per minute 
17-20 
21-25 
> 25 
Intubation 
a In addition to grading the measured local reaction at the greatest single diameter, the measurement should be recorded as a 
continuous variable. 
b Induration/Swelling should be evaluated and graded using the functional scale as well as the actual measurement. 
c Subject should be at rest for all vital sign measurements. 
d Oral temperature; no recent hot or cold beverages or smoking. 
e When resting heart rate is between 60-100 beats per minute. Use clinical judgement when characterizing bradycardia among 
some healthy subject populations, for example, conditioned athletes. 
 
 
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Systemic 
(General) 
Mild (Grade 1) 
Moderate (Grade 
2) 
Severe (Grade 3) 
Potentially Life 
Threatening 
(Grade 4) 
Nausea/Vomiting 
No interference 
with activity or 1-2 
episodes/24 
hours 
Some interference 
with activity or > 2 
episodes/24 hours 
Prevents daily 
activity, requires 
outpatient IV 
hydration 
ER visit or 
hospitalization 
for hypotensive 
shock 
Diarrhea 
2-3 loose stools
or < 400 gms/24
hours
4-5 loose stools or
400-800 gms/24
hours
6 or more watery 
stools or > 800 
gms/24 hours or 
requires 
outpatient IV 
hydration 
ER visit or 
hospitalization 
Headache 
No interference 
with activity 
Repeated use of 
non-narcotic pain 
reliever > 24 hours 
or some 
interference with 
activity 
Significant; any 
use of narcotic 
pain reliever or 
prevents daily 
activity 
ER visit or 
hospitalization 
Fatigue 
No interference 
with activity 
Some interference 
with activity 
Significant; 
prevents daily 
activity 
ER visit or 
hospitalization 
Myalgia 
No interference 
with activity 
Some interference 
with activity 
Significant; 
prevents daily 
activity 
ER visit or 
hospitalization 
Systemic Illness 
Mild (Grade 1) 
Moderate (Grade 
2) 
Severe (Grade 3) 
Potentially Life 
Threatening 
(Grade 4) 
Illness or clinical 
adverse event (as 
defined according 
to applicable 
regulations) 
No interference 
with activity 
Some interference 
with activity not 
requiring medical 
intervention 
Prevents daily 
activity and 
requires medical 
intervention 
ER visit or 
hospitalization 
U.S. Department of Health and Human Services, Food and Drug Administration, and Center for Biologics Evaluation and 
Research. Guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive 
vaccine clinical trials. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/toxicity-grading-scale-healthy-
adult-and-adolescent-volunteers-enrolled-preventive-vaccine-clinical 2007 Sep; 3-5 
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17.2 APPENDIX B: ADVERSE EVENTS OF SPECIAL INTEREST
For the purpose of standardization across multiple vaccine platforms, including those substantially 
different from Inovio’s platform, the below table lists adverse events of special interest (AESIs) 
relevant to MERS-CoV vaccine development.  
Body System 
AESI 
Respiratory 
Acute respiratory distress syndrome (ARDS) 
Pneumonitis/pneumonia 
Neurologic 
Generalized convulsion 
Aseptic meningitis 
Guillain-Barré Syndrome (GBS) 
Encephalopathy 
Encephalitis 
Myelitis 
Acute disseminated encephalomyelitis (ADEM) 
CNS vasculopathy (stroke) 
Hematologic 
Thrombocytopenia 
Disseminated intravascular coagulation (DIC) 
Immunologic 
Anaphylaxis 
Vasculitides 
Enhanced disease following immunization 
Other 
Local/systemic SAEs (regulatory criteria) 
Acute renal failure 
COVID-19 
Death, including maternal death, spontaneous abortion, stillbirth and 
neonatal death 
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Signature Page for VV-TMF-00167 v2.0
Signature Page for VV-TMF-00167 v2.0
Reason for signing: Approved
Name:
Role: Approver
Date of signature: 12-Feb-2021 20:37:28 GMT+0000
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CONFIDENTIAL 
Page 1 of 4 
Protocol Administrative Memo (PAM) # 1.0 
PAM Date: 12Oct2020 
To 
MERS-201 
Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 
for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy 
Volunteers 
Protocol Version:  1.0 
Protocol Version Date: 23Mar2020 
Sponsored by: 
Inovio Pharmaceuticals, Inc. 
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INO-4700 
  
        Protocol #: MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Protocol Administrative Memo #: 1.0 
 
 
 
CONFIDENTIAL 
Page 2 of 4 
 
 
Medical Monitor Approval Page 
 
 
Medical Monitor Signature: 
 
 
 
, M.D., Ph.D. 
 
Inovio Pharmaceuticals, Inc 
Date (ddMmmyyyy) 
 
 
This memo contains information that is considered to be administrative or clarifying in nature and does not 
meet the criteria of an immediate protocol amendment. Please distribute this memo to all appropriate staff 
members, and file it with the site’s protocol documents. Consult the local Institutional Review Board (IRB)/ 
Research Ethics Board (REB)/Ethics Committee (EC) regarding submission requirements for Protocol 
Administrative Memos (PAMs). 
 
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Protocol Administrative Memo #: 1.0 
CONFIDENTIAL 
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Principal Investigator Acknowledgement 
I have read and understood this Protocol Administrative Memo (PAM) and will incorporate it as 
part of the Protocol. I will submit this PAM, if required, to the Institutional Review Board 
(IRB)/Research Ethics Board (REB)/Ethics Committee (EC) overseeing the conduct of the 
clinical trial in accordance with their policies and procedures and local requirements. 
The Principal Investigator’s (PI’s) signature constitutes the PI’s acknowledgement of, and 
agreement with, this PAM and provides the necessary assurances that this clinical trial will be 
conducted in accordance with International Council for Harmonization (ICH)/Good Clinical 
Practice (GCP), local legal and regulatory requirements, and all stipulations of the Protocol. 
Principal Investigator Signature: 
Principal Investigator Printed Name (first and last) 
Principal Investigator Signature 
Date (ddMmmyyyy) 
Clinical Trial Site Number: 
Clinical Trial Site Name: 
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Protocol Administrative Memo #: 1.0 
CONFIDENTIAL 
Page 4 of 4 
Item 1: Administrative Change to Tables 4, 5 and 6
• Administrative change to Table 4, footnote “o,” Table 5, footnote “l,” and Table 6,
footnote “l.”
Each footnote indicates “4 x 8.5 mL (34 mL) whole blood in 10 mL Acid Citrate Dextrose (ACD, 
Yellow top) tubes per time point. Note: Collect a total of 68 mL whole blood prior to 1st dose 
(screening and prior to Day 0 dosing).”   
The footnotes should indicate 4 x 8 mL (approximately 32 mL) whole blood in 8 mL Cell 
Preparation Tubes (CPT) per time point.  Note:  Collect a total of 64 mL whole blood prior to 1st 
dose (screening and prior to Day 0 dosing).” 
Item 2: Typographical Error in Tables 5 and 6
• Typographical Error in Tables 5 and 6, Screening Visit Procedures.
Tables 5 and 6 indicate an “X” under “Screening” for “INO-4700 or placebo + EP” in error.  As 
indicated throughout the protocol, investigational product is not administered until Day 0.   
Item 3: Change in Safety Contact Information, Section 7.9
• The phone, fax and email address for safety reporting have been updated.
All references to the safety reporting contact information will be updated as follows: 
In Protocol V1.0 
Updated Information 
Sponsor Safety Email 
safety@inovio.com 
safety.inovio@apcerls.com 
Sponsor Safety Fax 
Sponsor Safety Phone 
Sites are to use the updated information only. 
MERS-201_Protocol Administrative Memo | VV-TMF-43494 | 1.0
Downloaded on 1/9/2023

Signature Page for VV-TMF-43494 v1.0
Signature Page for VV-TMF-43494 v1.0
Reason for signing: Approved
Name:
Role: Approver
Date of signature: 15-Oct-2020 13:56:57 GMT+0000
MERS-201_Protocol Administrative Memo | VV-TMF-43494 | 1.0
Downloaded on 1/9/2023

 
 
 
CONFIDENTIAL 
Page 1 of 4 
 
 
 
 
 
 
Protocol Administrative Memo (PAM) # 2.0 
PAM Date: 16Nov2020 
 
To 
 
MERS-201 
 
Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 
for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy 
Volunteers 
 
Protocol Version:  1.0 
Protocol Version Date: 23Mar2020 
 
 
Sponsored by: 
Inovio Pharmaceuticals, Inc. 
 
 
 
MERS-201_Protocol Administrative Memo_#2 | VV-TMF-47665 | 1.0
Downloaded on 1/9/2023

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PI

INO-4700 
  
        Protocol #: MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Protocol Administrative Memo #: 2.0 
 
 
 
CONFIDENTIAL 
Page 3 of 4 
 
 
Principal Investigator Acknowledgement 
 
I have read and understood this Protocol Administrative Memo (PAM) and will incorporate it as 
part of the Protocol. I will submit this PAM, if required, to the Institutional Review Board 
(IRB)/Research Ethics Board (REB)/Ethics Committee (EC) overseeing the conduct of the 
clinical trial in accordance with their policies and procedures and local requirements. 
 
The Principal Investigator’s (PI’s) signature constitutes the PI’s acknowledgement of, and 
agreement with, this PAM and provides the necessary assurances that this clinical trial will be 
conducted in accordance with International Council for Harmonization (ICH)/Good Clinical 
Practice (GCP), local legal and regulatory requirements, and all stipulations of the Protocol. 
 
 
Principal Investigator Signature: 
 
 
 
Principal Investigator Printed Name (first and last) 
 
 
 
Principal Investigator Signature 
Date (ddMmmyyyy) 
 
 
Clinical Trial Site Number: 
 
Clinical Trial Site Name: 
 
 
 
 
MERS-201_Protocol Administrative Memo_#2 | VV-TMF-47665 | 1.0
Downloaded on 1/9/2023

INO-4700 
  
        Protocol #: MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Protocol Administrative Memo #: 2.0 
 
 
 
CONFIDENTIAL 
Page 4 of 4 
 
Item 1: Change in Medical Monitor 
Note that effective 19Nov2020, 
 MD, FACP, FIDSA will assume Medical 
Monitor responsibilities for this trial. 
• Safety Contact Information, Section 7.9, Table 9: The updated Medical Monitor 
contact information is as follows: 
 
Table 9: Medical Monitor Direct contact Information 
Medical Monitor: 
 MD, FACP, FIDSA 
Email: 
 
Cell Phone: 
 
 
 
Sites are to use the updated information only. 
MERS-201_Protocol Administrative Memo_#2 | VV-TMF-47665 | 1.0
Downloaded on 1/9/2023

Signature Page for VV-TMF-47665 v1.0
Signature Page for VV-TMF-47665 v1.0
Reason for signing: Approved
Name: 
Role: Approver
Date of signature: 18-Nov-2020 12:42:32 GMT+0000
MERS-201_Protocol Administrative Memo_#2 | VV-TMF-47665 | 1.0
Downloaded on 1/9/2023

 
 
 
CONFIDENTIAL 
Page 1 of 4 
 
 
 
 
 
 
Protocol Administrative Memo (PAM) # 3.0 
PAM Date: 29Jan2021 
 
To 
 
MERS-201 
 
Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 
for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy 
Volunteers 
 
Protocol Version:  1.0 
Protocol Version Date: 23Mar2020 
 
 
Sponsored by: 
Inovio Pharmaceuticals, Inc. 
 
 
 
MERS-201_Protocol Administrative Memo_#3 | VV-TMF-50511 | 1.0
Downloaded on 1/9/2023

INO-4700 
  
        Protocol #: MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Protocol Administrative Memo #: 3.0 
 
 
 
CONFIDENTIAL 
Page 2 of 4 
 
 
Medical Monitor Approval Page 
 
 
Medical Monitor Signature: 
 
 
 
 MD, FACP, FIDSA  
 
Inovio Pharmaceuticals, Inc 
Date (ddMmmyyyy) 
 
 
This memo contains information that is considered to be administrative or clarifying in nature and does not 
meet the criteria of an immediate protocol amendment. Please distribute this memo to all appropriate staff 
members, and file it with the site’s protocol documents. Consult the local Institutional Review Board (IRB)/ 
Research Ethics Board (REB)/Ethics Committee (EC) regarding submission requirements for Protocol 
Administrative Memos (PAMs). 
 
MERS-201_Protocol Administrative Memo_#3 | VV-TMF-50511 | 1.0
Downloaded on 1/9/2023

INO-4700 
  
        Protocol #: MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Protocol Administrative Memo #: 3.0 
 
 
 
CONFIDENTIAL 
Page 3 of 4 
 
 
Principal Investigator Acknowledgement 
 
I have read and understood this Protocol Administrative Memo (PAM) and will incorporate it as 
part of the Protocol. I will submit this PAM, if required, to the Institutional Review Board 
(IRB)/Research Ethics Board (REB)/Ethics Committee (EC) overseeing the conduct of the 
clinical trial in accordance with their policies and procedures and local requirements. 
 
The Principal Investigator’s (PI’s) signature constitutes the PI’s acknowledgement of, and 
agreement with, this PAM and provides the necessary assurances that this clinical trial will be 
conducted in accordance with International Council for Harmonization (ICH)/Good Clinical 
Practice (GCP), local legal and regulatory requirements, and all stipulations of the Protocol. 
 
 
Principal Investigator Signature: 
 
 
 
Principal Investigator Printed Name (first and last) 
 
 
 
Principal Investigator Signature 
Date (ddMmmyyyy) 
 
 
Clinical Trial Site Number: 
 
Clinical Trial Site Name: 
 
 
 
 
MERS-201_Protocol Administrative Memo_#3 | VV-TMF-50511 | 1.0
Downloaded on 1/9/2023

INO-4700 
  
        Protocol #: MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Protocol Administrative Memo #: 3.0 
 
 
 
CONFIDENTIAL 
Page 4 of 4 
 
Item 1: Change in Medical Monitor 
Note that effective 01Feb2021, 
, MD will assume Medical Monitor responsibilities for 
this trial. 
• Safety Contact Information, Section 7.9, Table 9: The updated Medical Monitor 
contact information is as follows: 
 
Table 9: Medical Monitor Direct contact Information 
Medical Monitor: 
, MD 
Email: 
 
Phone: 
 
 
Sites are to use the updated information only, beginning 01Feb2021. 
MERS-201_Protocol Administrative Memo_#3 | VV-TMF-50511 | 1.0
Downloaded on 1/9/2023

Signature Page for VV-TMF-50511 v1.0
Signature Page for VV-TMF-50511 v1.0
Reason for signing: Approved
Name: 
Role: Approver
Date of signature: 29-Jan-2021 17:13:57 GMT+0000
MERS-201_Protocol Administrative Memo_#3 | VV-TMF-50511 | 1.0
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CONFIDENTIAL 
Page 1 of 4 
 
 
 
 
 
 
Protocol Administrative Memo (PAM) # 4.0 
PAM Date: 15Mar2021 
 
To 
 
MERS-201 
 
Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 
for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy 
Volunteers 
 
Protocol Version:  1.0 
Protocol Version Date: 23Mar2020 
 
 
Sponsored by: 
Inovio Pharmaceuticals, Inc. 
 
 
 
MERS-201_Protocol Administrative Memo_#4 | VV-TMF-52150 | 1.0
Downloaded on 1/9/2023

INO-4700 
  
        Protocol #: MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Protocol Administrative Memo #: 4.0 
 
 
 
CONFIDENTIAL 
Page 2 of 4 
 
 
Medical Monitor Approval Page 
 
 
Medical Monitor Signature: 
 
 
 
, MD  
 
Inovio Pharmaceuticals, Inc 
Date (ddMmmyyyy) 
 
 
This memo contains information that is considered to be administrative or clarifying in nature and does not 
meet the criteria of an immediate protocol amendment. Please distribute this memo to all appropriate staff 
members, and file it with the site’s protocol documents. Consult the local Institutional Review Board (IRB)/ 
Research Ethics Board (REB)/Ethics Committee (EC) regarding submission requirements for Protocol 
Administrative Memos (PAMs). 
 
MERS-201_Protocol Administrative Memo_#4 | VV-TMF-52150 | 1.0
Downloaded on 1/9/2023

INO-4700 
  
        Protocol #: MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Protocol Administrative Memo #: 4.0 
 
 
 
CONFIDENTIAL 
Page 3 of 4 
 
 
Principal Investigator Acknowledgement 
 
I have read and understood this Protocol Administrative Memo (PAM) and will incorporate it as 
part of the Protocol. I will submit this PAM, if required, to the Institutional Review Board 
(IRB)/Research Ethics Board (REB)/Ethics Committee (EC) overseeing the conduct of the 
clinical trial in accordance with their policies and procedures and local requirements. 
 
The Principal Investigator’s (PI’s) signature constitutes the PI’s acknowledgement of, and 
agreement with, this PAM and provides the necessary assurances that this clinical trial will be 
conducted in accordance with International Council for Harmonization (ICH)/Good Clinical 
Practice (GCP), local legal and regulatory requirements, and all stipulations of the Protocol. 
 
 
Principal Investigator Signature: 
 
 
 
Principal Investigator Printed Name (first and last) 
 
 
 
Principal Investigator Signature 
Date (ddMmmyyyy) 
 
 
Clinical Trial Site Number: 
 
Clinical Trial Site Name: 
 
 
 
 
MERS-201_Protocol Administrative Memo_#4 | VV-TMF-52150 | 1.0
Downloaded on 1/9/2023

INO-4700 
  
        Protocol #: MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Protocol Administrative Memo #: 4.0 
 
 
 
CONFIDENTIAL 
Page 4 of 4 
 
Item 1: Serum Chemistry - Bicarbonate Value 
Per Protocol Version 1.0, bicarbonate will be reported as HCO3.  However, some sites are set-
up to report bicarbonate as CO2. As the function of this test is supported by reporting as either 
HCO3 or CO2, using either is acceptable.   
• 
Table 4, Table 5, Table 6, Section 6.1.1 and Section 6.4: Bicarbonate [HCO3] should be 
Bicarbonate [HCO3 or CO2]. 
Protocol Version 2.0 allows for reporting using either HCO3 or CO2. 
MERS-201_Protocol Administrative Memo_#4 | VV-TMF-52150 | 1.0
Downloaded on 1/9/2023

Signature Page for VV-TMF-52150 v1.0
Signature Page for VV-TMF-52150 v1.0
Reason for signing: Approved
Name:
Role: Approver
Date of signature: 16-Mar-2021 15:16:08 GMT+0000
MERS-201_Protocol Administrative Memo_#4 | VV-TMF-52150 | 1.0
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CONFIDENTIAL 
Page 1 of 4 
 
 
 
 
 
 
Protocol Administrative Memo (PAM) # 5.0 
PAM Date: 20Jan2023 
 
To 
 
MERS-201  
 
Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 
for Middle East Respiratory Syndrome Coronavirus (MERS-Co) in Healthy 
Volunteers 
 
 
Protocol Version:  2.0  
Protocol Version Date: 12Feb2021 
 
 
Sponsored by: 
Inovio Pharmaceuticals, Inc. 
 
 
 
 
MERS-201 Protocol Administrative Memo #5 | VV-TMF-131691 | 1.0
Downloaded on 3/23/2023

INO-4700 
  
        Protocol #: MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Protocol Administrative Memo #: 5.0 
 
 
 
CONFIDENTIAL 
Page 2 of 4 
 
 
Medical Monitor Approval Page 
 
 
Medical Monitor Signature: 
 
 
 
, MD 
 
Inovio Pharmaceuticals, Inc 
Date (ddMmmyyyy) 
 
 
This memo contains information that is considered to be administrative or clarifying in nature and does not 
meet the criteria of an immediate protocol amendment. Please distribute this memo to all appropriate staff 
members, and file it with the site’s protocol documents. Consult the local Institutional Review Board (IRB)/ 
Research Ethics Board (REB)/Ethics Committee (EC) regarding submission requirements for Protocol 
Administrative Memos (PAMs). 
 
MERS-201 Protocol Administrative Memo #5 | VV-TMF-131691 | 1.0
Downloaded on 3/23/2023

INO-4700 
  
        Protocol #: MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Protocol Administrative Memo #: 5.0 
 
 
 
CONFIDENTIAL 
Page 3 of 4 
 
Principal Investigator Acknowledgement 
 
I have read and understood this Protocol Administrative Memo (PAM) and will incorporate it as 
part of the Protocol. I will submit this PAM, if required, to the Institutional Review Board 
(IRB)/Research Ethics Board (REB)/Ethics Committee (EC) overseeing the conduct of the 
clinical trial in accordance with their policies and procedures and local requirements. 
 
The Principal Investigator’s (PI’s) signature constitutes the PI’s acknowledgement of, and 
agreement with, this PAM and provides the necessary assurances that this clinical trial will be 
conducted in accordance with International Council for Harmonization (ICH)/Good Clinical 
Practice (GCP), International Organization for Standardization (ISO) guidelines, local legal and 
regulatory requirements, and all stipulations of the Protocol. 
 
 
Principal Investigator Signature: 
 
 
 
Principal Investigator Printed Name (first and last) 
 
 
 
Principal Investigator Signature 
Date (ddMmmyyyy) 
 
 
Clinical Trial Site Number: 
 
Clinical Trial Site Name: 
 
 
 
 
MERS-201 Protocol Administrative Memo #5 | VV-TMF-131691 | 1.0
Downloaded on 3/23/2023

INO-4700 
  
        Protocol #: MERS-201 
Inovio Pharmaceuticals, Inc. 
 
Protocol Administrative Memo #: 5.0 
 
 
 
CONFIDENTIAL 
Page 4 of 4 
 
Item 1: Discontinuation of Study into Part 2 and Analysis of Week 48 
Samples 
  
The MERS-201 trial will not proceed to Part 2.  The decision was made in collaboration 
between the Study Sponsor, Inovio Pharmaceuticals, Inc. (INOVIO) and the Study 
Funder, The Coalition for Epidemic Preparedness Innovations (CEPI). The decision was 
based on the Week 10 interim immunology results, which did not meet the criteria for Part 
2 dose selection as outlined in the Protocol Section 8.5.6, for any dose group in Part 1.  
There were no safety concerns related to the study and Week 10 interim safety results 
were consistent with the safety results across Inovio’s platform for intradermal 
administration. 
Since the study objectives were not met and the study is not moving forward into Part 2, 
no additional immunology data is needed. Therefore, the Part 1 Week 48 samples will 
not be analyzed. 
 
MERS-201 Protocol Administrative Memo #5 | VV-TMF-131691 | 1.0
Downloaded on 3/23/2023

Signature Page for VV-TMF-131691 v1.0
Signature Page for VV-TMF-131691 v1.0
Reason for signing: Approved
Name: 
Role: Approver
Date of signature: 20-Jan-2023 21:27:47 GMT+0000
MERS-201 Protocol Administrative Memo #5 | VV-TMF-131691 | 1.0
Downloaded on 3/23/2023