Multicenter, Randomized, Combined Phase I Dose-escalation and Phase IIa Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Immunogenicity of GLS-5310 DNA Vaccine, Administered Intradermally Against SARS-CoV-2 in Healthy Adults
Phase: PHASE1
Conditions: SARS-CoV-2
Sponsor: GeneOne Life Science, Inc.

CoV2-001 
GeneOne Life Science, Inc. 
Clinical Protocol 
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Brief protocol title 
CoV2-001 
Formal protocol title 
Multicenter, randomized, combined Phase I dose-escalation 
and Phase IIa double-blind, placebo-controlled study of the 
safety, tolerability, and immunogenicity of GLS-5310 DNA 
vaccine administered intradermally against SARS-CoV-2 
Principal Investigator 
Woo Joo Kim MD 
Sub Investigators 
Regulatory Sponsor: 
GeneOne Life Science Inc.  
Parc.1 NH Finance Tower (Tower 2), 20th floor 
108 Yeoui-Daero, Yeongdeungpo-Gu,  
Seoul 07335, Korea 
IND Protocol Number: 
Clinical Trials.gov #: 
NCT04673149 
Version Summary 
Initial version:  
Version 5.0 
28 MAR 2022 
Amendment:  

 
 
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Clinical Protocol 
 
 
 
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CONFIDENTIAL 
The information in this document is considered privileged and confidential by GeneOne Life 
Science, Inc. and may not be disclosed to others except to the extent necessary to obtain 
Institutional Review Board/Ethics committee 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 must not be further disclosed without the 
written permission of GeneOne Life Science, Inc. Any supplemental information added to this 
document is also confidential and proprietary information of GeneOne Life Science, Inc. 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 ACKNOWLEDGEMENT 
 
 
I have read this Protocol and agree that it contains all necessary details for carrying out the 
study described. I understand that it must be reviewed by the Institutional Review Board or 
Independent Ethics Committee overseeing the conduct of the study and receive approval or a 
favorable opinion before implementation. 
 
The signature of the Principal Investigator and Sponsor below constitute their approval of this 
protocol and provide the necessary assurances that this study will be conducted according to 
the Declaration of Helsinki, GCP, ICH guidelines, local legal and regulatory regulations as well 
as to all stipulations of the protocol in both the clinical and administrative sections, including 
statements regarding confidentiality. 
 
 
 
 
_________________________________ 
 
 
_________________ 
Investigator’s printed name and signature 
 
 
Date 
 
 
 
 
28 MAR 2022 
_________________________________ 
 
 
_________________ 
Medical Monitor 
 
 
 
 
 
Date 
 
 
 
Protocol Number: CoV2-001 
Version Number:  5.0 / Version Date: 28 MAR 2022 
 
 
  
 
 
 
 

 
 
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Clinical Protocol 
 
 
 
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TABLE OF CONTENTS 
 
PROTOCOL ACKNOWLEDGEMENT ................................................................................................... 3 
TABLE OF CONTENTS ........................................................................................................................... 4 
CoV2-001: CLINICAL PROTOCOL SYNOPSIS .................................................................................. 9 
[Abbreviations and Terms] ......................................................................................................................... 19 
1. 
INTRODUCTION .............................................................................................................................. 21 
1.1 
Background and Rationale .................................................................................................. 21 
1.1.1 
The SARS-CoV-2 Spike protein as a vaccine target ............................................. 21 
1.1.2 
The SARS-CoV-2 ORF3a protein as a vaccine antigenic target ........................ 22 
1.2 
Investigational Agent ............................................................................................................ 23 
1.3 
Dose and Regimen Rationale .............................................................................................. 23 
1.3.1 
Function of Suction after intradermal administration of DNA vaccine ............................ 24 
1.4 
Risk/Benefit Assessment ..................................................................................................... 25 
2. 
HYPOTHESIS AND STUDY OBJECTIVES ................................................................................ 25 
2.1 
Hypothesis ............................................................................................................................... 25 
2.2 
Primary Objectives and Outcome Variables – Phase I & II ......................................... 25 
2.3 
Secondary Objectives and Outcome Variables – Phase I & II .................................... 25 
2.4 
Exploratory Objectives ......................................................................................................... 25 
3. 
STUDY DESIGN ............................................................................................................................... 26 
3.1 
Interim Safety Monitoring .................................................................................................... 28 
4. 
SELECTION AND ENROLLMENT OF PARTICIPANTS .......................................................... 28 
4.1 
Recruitment of Participants ................................................................................................ 28 
4.2 
Inclusion Criteria .................................................................................................................... 28 
4.3 
Exclusion Criteria ................................................................................................................... 29 
4.4 
Discontinuation/Withdrawal of Study Participants ....................................................... 30 
4.5 Clinical trial termination and early termination ................................................................... 31 
5. 
STUDY PROCEDURES AND ADMINISTRATION PLAN ........................................................ 32 
5.1 
Overall Procedure .................................................................................................................. 32 
5.2 
Administration of GLS-5310 vaccine ................................................................................ 33 
5.3 
Concomitant Treatment ........................................................................................................ 33 
5.3.1 
Allowed Concomitant Treatment ............................................................................... 33 

 
 
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5.3.2 
Prohibited Concomitant Treatment ........................................................................... 33 
6. 
STUDY PRODUCT .......................................................................................................................... 34 
6.1 
Investigational Product ........................................................................................................ 34 
6.2 
Packaging and Labeling ....................................................................................................... 35 
6.3 
Handling of Study Drug ........................................................................................................ 35 
6.4 
Dispensing of Study Drug .................................................................................................... 35 
6.5 
Precautions with Investigational Medicinal Product .................................................... 36 
6.6 
Preparation of Investigational Product ............................................................................ 36 
6.7 
Record of Investigational Product Disposition at Site ................................................. 36 
6.8 
Return and Destruction of Investigational Product ...................................................... 36 
6.9 
Use of JM-11 ............................................................................................................................ 36 
6.9.1 
Purpose of use and principle of operation .................................................................. 36 
6.9.2 
Information of JM-11 ......................................................................................................... 37 
6.9.3 
Education and qualification ............................................................................................ 37 
6.10  Device Accountability ............................................................................................................. 38 
7. 
STUDY PROCEDURES AND TREATMENTS ............................................................................ 38 
7.1 
Procedures by Visit (also see Tables S2 and S3) .......................................................... 38 
7.1.1 
Visit 1: Determine eligibility, obtain informed consent, enrollment, 1st 
vaccination....................................................................................................................................... 38 
7.1.2 
Visit 2: Safety follow-up. .............................................................................................. 38 
7.1.3 
Visit 3: Follow-up and booster vaccination ............................................................. 39 
7.1.4 
Telephone Visit 1: Safety follow-up. ......................................................................... 39 
7.1.5 
Visit 4: Post-vaccination follow-up, unblinding ..................................................... 39 
7.1.6 
Visits 5, 6, 7: Follow-up ................................................................................................ 39 
7.1.10 
Visit 8: End of Study or Early Termination (see above for Phase I) ................. 40 
7.1.11 Unscheduled visits ............................................................................................................ 40 
7.2 Procedures by Visit (GLS-5310 revaccination group, see clinical trial schedule S4)40 
7.2.1 
Visit 1: Vaccination ........................................................................................................ 40 
7.2.2 
Visit 2: Safety follow-up. .............................................................................................. 40 
7.2.3 
Visit 3: Follow-up and booster vaccination ............................................................. 41 
7.2.4 
Telephone Visit 1: Safety follow-up. ......................................................................... 41 
7.2.5 
Visit 4: Post-vaccination follow-up ............................................................................ 41 
7.2.6 
Visits 5, 6, 7: Follow-up ................................................................................................ 41 

 
 
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7.2.10 
Visit 8: End of Study or Early Termination .............................................................. 41 
7.2.11 Unscheduled visits ............................................................................................................ 42 
7.3 
Timing and Evaluations ........................................................................................................ 42 
7.3.1 
Informed Consent .......................................................................................................... 42 
7.3.2 
Enrollment and Intake visit .......................................................................................... 42 
7.3.3 
Adverse effects ............................................................................................................... 42 
7.4 
Assessment of injection site ............................................................................................... 43 
7.5  
Immunogenicity assessments ............................................................................................ 43 
8  
Safety assessments .................................................................................................................. 44 
8.1.1  
Safety Parameters .............................................................................................................. 44 
8.1.2  
Safety Evaluations ............................................................................................................. 44 
8.1.2.1  
Adverse Events (AEs) ................................................................................................... 44 
8.2.1.1  
Definition of Adverse Events ...................................................................................... 44 
8.1.2.1.2  
Serious Adverse Events (SAEs) ............................................................................. 45 
8.1.2.1.3  
Solicited local/systemic AE ..................................................................................... 46 
8.1.2.1.4  
Unexpected Adverse Drug Reactions (ADRs) .................................................... 46 
8.1.2.1.5   Evaluation of adverse events ................................................................................... 47 
8.1.2.1.6  
Assessing Severity (Intensity) ............................................................................ 47 
8.1.2.1.7 
Causal Relationship of Clinical Material to Adverse Events .......................... 47 
8.1.2.1.8 
Measures related to investigational products .................................................... 48 
8.1.2.1.9 
Treatment for adverse Events................................................................................. 48 
8.1.2.1.10Consequences of adverse Events ........................................................................... 48 
8.1.6 
Procedures for Documenting Pregnancy During Study ...................................... 49 
8.1.7 
Post-study Reporting Requirements ........................................................................ 49 
8.2 
Methods and Timing for Collection and Recording of Safety Data .......................... 50 
8.3 
Safety and Toxicity Management ....................................................................................... 50 
8.3.1 
Events Requiring Expedited Reporting .................................................................... 50 
8.3.2 
Stopping Rules ............................................................................................................... 50 
8.3.3 
Unblinding ........................................................................................................................ 51 
9. 
EVALUATION OF IMMUNE RESPONSES ................................................................................. 51 
9.1 
Efficacy Parameters .............................................................................................................. 51 
9.2  
Immunogenicity assessments ............................................................................................ 52 

 
 
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9.2.1 
SARS-CoV-2 Binding ELISA ............................................................................................ 52 
9.2.2 
SARS-CoV-2 Serum Neutralization ................................................................................ 52 
9.2.3 
SARS-CoV-2 ELISpot ........................................................................................................ 52 
10. 
EVALUATION OF EXPLORATORY ENDPOINTS ........................................................ 52 
10.1.1 
Phase I Exploratory Endpoints ................................................................................... 52 
11. 
STATISTICAL METHODS and CONSIDERATIONS ............................................................ 53 
11.1 
Data Sets to be Analyzed ..................................................................................................... 53 
11.2 
Demographic and Other Baseline Characteristics ........................................................ 54 
11.3 
Safety Analysis ....................................................................................................................... 54 
11.3.1 
Adverse events ............................................................................................................... 54 
11.3.2 
Laboratory Data .............................................................................................................. 54 
11.4 
Immune Response Analysis ................................................................................................ 54 
11.5 
Interim Analysis ...................................................................................................................... 55 
11.6 
Sample Size and Randomization ....................................................................................... 55 
11.7 
Missing Values ........................................................................................................................ 55 
11.8 
Unblinding ................................................................................................................................ 55 
12. 
DATA COLLECTION, MONITORING AND AE REPORTING ............................................. 55 
12.1 
Confidentiality ......................................................................................................................... 55 
12.2 
Source Documents ................................................................................................................ 56 
12.3 
Data Collection ....................................................................................................................... 56 
12.4 
Record Retention ................................................................................................................... 56 
12.5 
Safety and Quality Monitoring and Record Availability ............................................... 56 
12.6 
Adverse event (AE) Reporting ............................................................................................ 56 
12.6.1 
Study Reporting Period of Adverse Events ............................................................ 56 
12.6.2 
Study Reporting Period for Serious Adverse Events ........................................... 56 
12.6.3 
Notification of Serious Adverse Events ................................................................... 57 
12.7 
Study Discontinuation .......................................................................................................... 58 
13. 
ETHICAL CONSIDERATIONS AND ADMINISTRATIVE PROCEDURES ........................ 58 
13.1 
Clinical trial management standards and Declaration of Helsinki ................................ 58 
13.2 
Consent of Study Participant .................................................................................................. 59 
13.3 
Compliance with Ethics ............................................................................................................ 59 
13.4 
Study Participant Safety Protection Measures .................................................................. 59 

 
 
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13.5 
Publication of Research Findings ......................................................................................... 60 
13.6 
Quality Control and Reliability Assurance .......................................................................... 60 
13.6 
Approval of Clinical Trial Protocol ........................................................................................ 60 
13.6 
Changes in Clinical Trial Protocol ......................................................................................... 60 
13.6 
Data and Safety Monitoring Board (DSMB) ......................................................................... 61 
14. 
INFORMATION OF THE PERSON WHO INTENDS TO CONDUCT THE CLINICAL 
TRIAL 61 
14.1 
Sponsor .................................................................................................................................... 61 
14.2 
Principal Investigator ............................................................................................................ 61 
14.3 
Contract Research Organization ........................................................................................ 61 
15. 
OTHER MATTERS NECESSARY TO SAFELY AND SCIENTIFICALLY CONDUCT 
CLINICAL TRIALS .................................................................................................................................. 61 
15.1 Clinical Trials Site ..................................................................................................................... 61 
15.2 
Principal Investigator and Clinical Site Staffs ................................................................ 62 
15.3 
Protocol Violation .................................................................................................................. 62 
15.4 
Criteria for Treatment of Subjects after Clinical Trials ................................................ 62 
16. 
REFERENCES ............................................................................................................................. 62 
 
 

 
 
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CoV2-001: CLINICAL PROTOCOL SYNOPSIS 
Study Title: Multicenter, randomized, combined Phase I dose-escalation and Phase IIa double-blind, 
placebo-controlled study of the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine 
administered intradermally against SARS-CoV-2 
Number of study sites and Countries/Regions: 5, Korea 
Number of study participants: 45 (Phase I), 120 (Phase IIa) 
Study Phase: I / IIa 
Study Type: Phase I: Dose-ranging 
Phase IIa:  Multi-center, Randomized, Double-blind, Placebo 
Study Period: About 20 months from the date of approval of the clinical study by the Ministry of Food 
and Drug Safety and the Institutional Review Board 
- Recruitment period for test subjects: about 5 months 
- Clinical trial period for each subject: at least 48 weeks 
Research Hypothesis: GLS-5310 DNA vaccine delivered intradermally (ID) with JM-11 will be safe, 
well-tolerated and that vaccination will elicit immune responses against SARS-CoV-2 vaccine 
antigens. 
Primary study objectives– Phase I & IIa:  
• 
Evaluate the safety and tolerability of GLS-5310 vaccine  
• 
Determine post-vaccination binding antibody responses induced by GLS-5310 relative to 
treatment arm 
Secondary study objectives– Phase I & IIa: 
• 
Determine the T cell responses induced by GLS-5310 
• 
Determine the neutralizing antibody response induced by GLS-5310  
Exploratory study objectives: 
Phase I exploratory objectives 
• 
Determine IgG antibody responses after a single dose of vaccine related to treatment arm  
• 
Determine whether passive transfer of human serum can protect against pulmonary infection 
from SARS-CoV-2 challenge in an animal infection model  
Phase II exploratory objectives 
• 
Determine the persistence of immune responses following vaccination with GLS-5310 
• 
Determine the extent of immune boosting for participants who are seropositive at baseline 
following vaccination with GLS-5310  
 
Primary study endpoints– Phase I & IIa:  
• 
Evaluate the adverse events (Toxicity Grading Scale for Healthy Adult and Adolescent 
Volunteers Enrolled in Preventative Vaccine Clinical Trials) 
• 
Determine of GMT and seroconversion rate of SARS-CoV-2 Spike and ORF3a protein specific 
binding antibody responses induced by GLS-5310 relative to treatment arm (Endpoint titer of 
binding antibody in serum at each timepoint) 
Secondary study endpoints– Phase I & IIa:  
• 
Determine the positive responder rate of T cell responses induced by GLS-5310 (Antigen-
specific interferon gamma (IFN-γ) secretion T-cell response in PBMC at each timepoint) 
• 
Determine of GMT and positive responder rate of the neutralizing antibody response induced 
by GLS-5310 (plaque-reduction neutralizing titer in serum at each timepoint) 

 
 
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Exploratory study endpoints 
Phase I 
• 
Determine binding antibody responses after a single dose of vaccine related to treatment arm 
(Endpoint titer of binding antibody in serum at each timepoint)  
• 
Determine whether passive transfer of human serum can protect against pulmonary infection 
from SARS-CoV-2 challenge in an animal infection model (Survival rate, blood and viral load 
measurement of major organs, pathological examination of respiratory/lung area, 
immunogenicity evaluation) 
Phase IIa  
• 
Determine the persistence of immune responses following vaccination with GLS-5310 
(Endpoint titer of binding antibody in serum at each timepoint, Antigen-specific interferon 
gamma (IFN-γ) secretion T-cell response in PBMC at each timepoint, plaque-reduction 
neutralizing titer in serum at each timepoint) 
• 
Determine the extent of immune boosting for participants who are seropositive at baseline 
following vaccination with GLS-5310 (Endpoint titer of binding antibody in serum at each 
timepoint, Antigen-specific interferon gamma (IFN-γ) secretion T-cell response in PBMC at 
each timepoint, plaque-reduction neutralizing titer in serum at each timepoint 
• 
Determine whether immune responses to GLS-5310 of participants age 66-85 years differ from 
those age 65 years and younger. 
Table S1: Dosing arms and treatment regimen 
Study Phase 
Study 
Arm 
N 
Route 
GLS-5310 
Dose 
Vaccination 
schedule 
Table of 
events 
1 
1a 
15 
ID 
0.6 mg 
0 – 8 weeks 
S2 
1 
1b 
15 
ID 
1.2 mg 
0 – 8 weeks 
S2 
1 
1c 
15 
ID 
1.2 mg 
0 – 12 weeks 
S3 
2 
2a 
40 
ID 
Placebo 
0 – 8 weeks 
S2 
2 
2b 
80 
ID 
1.2 mg  
0 – 8 weeks 
S2  
 

 
 
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Study design: 
This Phase I / IIa study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA 
vaccine. 
The Phase I portion of this study is an open-label, dose escalation study to assess two dose levels of 
GLS-5310 DNA vaccine (0.6 and 1.2 mg) as part of two vaccination regimens (0-8 weeks and 0-12 
weeks). After enrolling study arm 1a (0.6 mg), participants will be randomized to study arms 1b and 1c. 
GLS-5310 will be administered via intradermal (ID) injection using the Mantoux technique followed by 
suction applied over the vaccination site using the JM-11 device. The primary outcome measures are 
(1) the safety and tolerability of GLS-5310 given ID with JM-11 and (2) binding antibody responses 
elicited by vaccination. Secondary outcome measures are the (3) T cell responses elicited to vaccine 
antigens and (4) neutralizing antibody titers. Exploratory goals of the study are to determine the IgG 
antibody responses after a single vaccination relative to treatment arm and whether passive transfer of 
immune serum can protect animals from pulmonary disease.  
Dose escalation within the Phase I portion of the study will occur as follows. Study arm 1a (0.6 mg per 
vaccination) will be vaccinated and followed to the Week 1 safety visit. If no vaccine-associated severe 
adverse events (SAEs) have been documented, then enrollment into study arms 1b and 1c (1.2 mg per 
vaccination) will occur in a randomized manner. Phase I subjects complete Visit 4, an interim analysis 
to evaluate safety and binding antibody response is performed. The assessment of adverse events is 
performed after visit 1 to study arm 1a. The interim analysis is performed after visit 4 for study arms 1a, 
1b, and 1c of the Phase I, and after visit 4 for study arms 2a and 2b of the Phase IIa. In order to enter 
the Phase IIa, the seroconversion rate for the antibody binding between the study arms is >70%, and 
the incidence of serious adverse reactions (Grade 3 or higher) related to the investigational drug should 
be no more than 1 case. In addition, the safety and immunogenicity results are evaluated on the data 
and safety monitoring board (DSMB). 
Escalation to Phase IIa will occur based on the interim analysis.  
The Phase IIa portion of this study is designed as a randomized, double-blind, placebo-controlled study 
with only a single active study drug arm. Subjects will be randomized to receive either placebo or GLS-
5310 vaccine in a 1:2 ratio. The primary and secondary goals of the Phase IIa study are the same as 
the Phase I study. Exploratory goals of the Phase IIa study are to determine the persistence of the 
immune response following vaccination with GLS-5310 and the extent of immune boosting for those 
who are enrolled and are seropositive at baseline. The study will be unblinded at the post-vaccination 
visit (study visit 4) at which time subjects will be informed of their treatment assignment. Subjects who 
were assigned to the placebo group will be offered to be vaccinated with GLS-5310. Subjects assigned 
to the placebo group who choose to be vaccinated with GLS-5310 will be followed for a year from 1st 
GLS-5310 vaccination (Table S4); subjects assigned to the placebo group but who decline vaccination 
with GLS-5310 will be followed for a year from study entry as per the original study protocol (Table S3). 
Sub-studies 
A sub-study will be included within the Phase IIa portion of CoV2-001 clinical trial.  
Participants 66-85 years of age: 30 persons will be recruited into the study to examine whether immune 
responses in this age group are similar or different from those age 66-85 years of age.  
The above subgroup will be randomized as part of the main study, and not separately randomized. 
At randomization, the initial 5 subjects are set as the sentinel group to confirm the safety of the elderly 
group. When the sentinel group is vaccinated with the clinical trial drug, the vaccination is carried out 
at an interval of at least 24 hours between each subject. Five subjects aged 65 to 74 years will be 
enrolled as a sentinel group for the older age cohort. If there are no adverse drug reactions (ADRs) 
occurring within the 7 days after the first vaccination in the sentinel group, then enrollment into the older 
age cohort can proceed. 
Study outcome will be based on the ITT analysis inclusive of all subgroups, however, subgroup analysis 
will be performed as above as an exploratory endpoint.  

 
 
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Sample size considerations: 
For the Phase I study, the sample size of 15 participants per group will allow detection of an increase 
in adverse events of 13% with 88% statistical power using a 2-sided alpha of 0.10. The sample size will 
allow assessment of a difference of 35% in seroconversion between groups after a complete 
vaccination series or after a single vaccination at a similar statistical power. The sample size will also 
allow assessment of a difference in geometric mean titers by ELISA, determined by analysis of 
variance, between dose levels (low dose versus high dose) of 35% with 86% statistical power at an 
alpha of 0.10. These results will be used to guide selection of vaccination regimen for Phase IIa. 
For the Phase IIa study, the sample size of 300 participants, randomized 2:1 vaccine to placebo will 
allow detection of a difference in adverse events of 18% with 82% statistical power at alpha of 0.05. 
The sample size will allow assessment of a difference in seroconversion between groups of at least 
10% with greater than 95% statistical power at alpha of 0.05. For a sample size of 126 participants, 
randomized 2:1 vaccine to placebo will yield 80% probability to detect a difference in the rate of adverse 
events of 28% or greater. A sample size of N=126 will allow detection of a difference in seroconversion 
of 14% with 80% statistical power. Safety and immunogenicity will be determined at planned Interim 
Analysis and after all vaccinations are completed. 
Safety assessments: 
Participants will be monitored at each study visit for adverse events. Laboratory safety assessments 
will be performed as indicated in the schedule of events to determine whether there are any changes 
in hematologic parameters, electrolytes, or renal function relative to pre-vaccination assessment. 
Subjects administered GLS-5310 will be followed for a year from their first vaccination with GLS-5310 
regardless of initial study arm randomization. In the Phase IIa study, subjects, will be followed for 48 
weeks from first vaccination, however, subjects assigned to placebo and who chose to be vaccinated 
with GLS-5310, will be followed for a year from first vaccination with GLS-5310 or a total of 60 weeks.  
Immunogenicity analysis: 
This study is not powered to determine efficacy of the vaccine to prevent SARS-CoV-2 disease. The 
study is, however, powered to assess whether the vaccine can induce immune responses. 
Immunogenicity assessments will measure binding antibodies by ELISA; neutralizing antibodies by 
either live virus PRNT, pseudovirus assay, or binding inhibition assay; and T cell cellular responses by 
ELISPOT.  

 
 
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Inclusion criteria: 
1. Age greater than 19 to 85 years of age (Phase I will be restricted to an upper age limit of 50 
years of age); Phase IIa will allow enrollment of 30 persons 66 to 85 years of age.  
2. Able to provide informed consent  
3. Able and willing to comply with study procedures 
4. For women of childbearing potential, able and willing to use an approved form of pregnancy 
prevention through to 4 weeks post boost vaccination  
Exclusion criteria: 
1. Current or planned pregnancy through to 4 weeks post-boost vaccination for women of 
childbearing potential 
2. Currently breastfeeding 
3. Current or past participation in a coronavirus (MERS-CoV, SARS-CoV-2) vaccine study 
4. Administration of an investigational agent within 6 months of the 1st dose 
5. Administration of a vaccine within 28 days prior to the 1st dose 
6. Administration of immune globulin or blood-derived medicinal product within 16 weeks of 
enrollment 
7. Administration of an anti-TNFα inhibitor such as infliximab, adalimumab, etanercept, or anti-
CD20 monoclonal antibody rituximab within 24 weeks from enrollment  
8. Current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater, 
dexamethasone of 3 mg or greater; or the equivalent dose of other systemic corticosteroids 
9. Administration of any Immunosuppressive Drug or Immunomodulator within 3 months of the 
1st dose 
10. History of bone marrow transplantation  
11. Current or planned chemotherapy treatment for hematologic or solid tumor during study 
period or treatment during the 5 years prior to enrollment 
12.  Respiratory disease (ex. Asthma, Chronic obstructive lung disease) that is uncontrolled per 
their treating physician 
13. Cardiovascular disease (ex. myocardial ischemia, congestive heart failure, cardiomyopathy, 
clinically significant arrhythmia) that is uncontrolled per their treating physician 
14. Uncontrolled Hypertension (Systolic pressure >150mmHg or Diastolic pressure >95mmHg) 
15. Uncontrolled Diabetes 
16. Severe allergic reaction or anaphylactic reaction after vaccination in the past  
17. Immunosuppresion including immunodeficiency disease or family history  
18. Positive of serum test at screening of Hepatitis B surface antigen, Hepatitis A IgM, HIV, or 
Hepatitis C. Persons who are Hepatitis C seropositive, and for whom an HCV RNA test is 
negative, are allowed into the study.  
19. Baseline screening lab(s) with Clinically Significant abnormality (Grade 2 or higher) 
20. Serious adverse reaction to a drug containing Investigational Product (GLS-5310) or other 
ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-
inflammatory disease control, etc. or an allergic history 
21. History of hypersensitivity to vaccination such as Guillain-Barre syndrome  
22. History of PCR-confirmed infection with SARS-CoV-2 or positive SARS-CoV-2 antibody or 
PCR test at screening  
23. Subjects who have been contact with COVID-19 infections in the past prior to administration, 
have been classified as COVID-19 confirmed patients, medical patients or patients with 
symptoms or have been identified with SARS and MERS infection history in the past 
24. Acute over 37.5℃ fever, cough, difficulty breathing, chills, muscle aches, headache, sore 
throat, loss of smell, or loss of taste within 72 hours prior to administration  
25. Healthcare workers participating in the medical examination of patients infected with COVID-
19 or high-risk individuals who are likely to be occupationally exposed to SARS-CoV-2 
26. Not willing to allow storage and future use of samples for SARS-CoV-2 related research 
27. Prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness 
28. Any illness or condition that, in the opinion of the investigator, may affect the safety of the 
subject or the evaluation of a study endpoint 

 
 
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29. Receipt of a vaccine to prevent COVID-19 infection 
Safety evaluation analysis method: Adverse events occurring after vaccination are summarized 
according to frequency, and presented according to SOC and PT along with the number and ratio 
of subjects with adverse events. The continuous response variable at each time point and the 
change from baseline are summarized as mean, median, minimum and maximum values. 
Categorical response variables are summarized as a percentage for each time point. 
 
Data for the Phase IIa study will be unblinded after database lock for analysis.  Since subjects who 
were randomized to placebo will have the opportunity to be given the vaccine, safety assessments 
can be divided into 3 groups: 
1) Randomized to vaccine 
2) Randomized to placebo 
3) Subset of Placebo subjects who received vaccine after unblinding 
Safety comparison will be made based on the randomization allocations and separately on the placebo 
randomized subject who rolled over to vaccine.  These 2 vaccine groups will not be pooled. 
Immunogenicity evaluation analysis method: Although this clinical trial has no statistical power to 
evaluate the effectiveness of a vaccine for preventing disease against SARS-CoV-2, the immune 
response induced by the vaccine can be evaluated by a statistical analysis. Immunogenicity results 
are classified as responders/non-responders and are expressed as the frequency of each assay 
response for each group at each time point where the evaluation is performed. The proportions of 
the differences between each group and an estimate of the correct 95% binominal and 95% 
confidence intervals are calculated. Since phase 1 clinical trials cannot secure sufficient power 
between administration regimens, comparisons between groups are analyzed using Fisher's Exact 
Test. 
 
 Similar to the safety assessments, subject who were randomized to receive Placebo who then received 
vaccines after the study was unblinded will be followed for immunogenicity.  Results of this group 
will not be compared to the randomized vaccine group or pooled with the original randomized 
vaccine group results. 
 
 
 
 
 

 
 
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Clinical Protocol 
 
 
 
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Table S2: Schedule of Events (Vaccinations at 0 and 8 weeks) 
Tests and Observations 
Visit 1 
Visit 
2 
Visit 
3 
Tele 
Visit  
Visit 
4 
Visit 
5 
Visit 
6 
Visit 
7 
Visit 
8 
Un-
sched 
Time relative to enrollment 
Screen 
Enroll 
Wk 
1 
Wk 
8 
Wk  
9 
Wk 
12 
Wk 
16 
Wk 
24 
Wk 
36 
Wk 
48 
N/A 
Permitted window (days) 
 
±2d 
±3d 
±3d 
±3d 
±4d 
±7d 
±7d 
±7d 
N/A 
Clinical Evaluations 
 
 
 
 
 
 
 
 
 
 
Review Record Prior and Concomitant 
Meds 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
Physical Exam and Vital Signs 2 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
Safety Evaluations* 
 
 
 
 
 
 
 
 
 
 
Record Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Examine injection site and record 
findings 
X 
X 
X 
X 
X 
 
 
 
 
X 
Blood for Hematology 3: CBC with 
differential 
X 
X 
 
 
X 
 
 
 
X 
 
Blood for Chemistry Testing 4: Sodium, 
potassium, glucose, BUN, Cr, ALT, Bili 
X 
X 
 
 
X 
 
 
 
X 
 
Serological test 5 
X 
 
 
 
 
 
 
 
 
 
Record most recent HgbA1c (diabetics 
only) 6 
X 
 
 
 
 
 
 
 
 
 
Chest X-ray 
X 
 
 
 
 
 
 
 
 
 
12-lead ECG 
X 
 
 
 
 
 
 
 
 
 
PCR or Antibody test for SARS-CoV-2 
X 
 
 
 
 
 
 
 
 
 
Urine for pregnancy testing (as 
applicable) 
X 
 
X 
 
 
 
 
 
 
 
Study Related Procedures 
 
 
 
 
 
 
 
 
 
 
Administer study drug  
X 
 
X 
 
 
 
 
 
 
 
Subject Diary 7 
X 
X 7 
X 
 
X 7 
X 
X 
 
 
 
VAS Score 
X 
 
X 
 
X 
X 
 
 
 
 
Collect blood for serum 8 
X 
 
X 
 
X 
X 
X 
X 
X 
 
Collect blood for PBMCs 9 
X 
 
X 
 
X 
X 
X 
X 
X 
 
Estimated blood volume  
 
 
 
 
 
 
 
 
 
 
Maximum blood volume collected 
60 
10 
50 
 
60 
50 
50 
50 
60 
 
 
*  If there are test results for safety evaluation items within 1 week from the first investigational product vaccination 
date, it can be used 
# Check the occurrence of adverse events by telephone. 
1 Written Informed Consent must be obtained PRIOR to any study procedures; document that a completed copy has 
been provided to participant.  
2 At enrollment, a full physical exam is performed; height and weight are recorded. At follow-up and unscheduled 
visits, only a targeted physical exam is performed determined by the presence of symptoms and directed to those 
organ systems only.  
3 Blood for Hematology: RBC, hemoglobin, hematocrit, platelet, WBC, neutrophil, lymphocyte, monocyte, eosinophil, 
basophil  
4 Blood for Chemistry Testing: Sodium, potassium, glucose, BUN, Cr, ALT, Bili, Ca, Cl, AST, ALP, CPK, albumin, 
total protein, total cholesterol 
5 Serological test: Hepatitis B (HBsAg), Hepatitis A (IgG and IgM), HIV, Hepatitis C- HCV RNA testing, if necessary) 
6 Obtain HgbA1c if test result within past 3 months is not available 
7 Subject diary their responses up to 7 days after vaccination of the investigational product on the clinical trial-related 
record sheet distributed to the investigator. Diaries are collected and reviewed at indicated visits 
8 For serum, collect 1 x 10 mL red top or serum separator tubes;  
9 For PBMCs, collect 4 x 10 mL ACD tubes; 
 

 
 
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Clinical Protocol 
 
 
 
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Table S3: Schedule of Events (Vaccinations at 0 and 12 weeks, Phase 1 study ONLY) 
Tests and Observations 
Visit 1 
Visit 
2 
Visit 
3 
Tele
phon
e 
Visit 
1# 
Visit 
4 
Visit 
5 
Visit 
6 
Visit 
7  
Visit 
8 
Unsched
uled 
Time relative to enrollment 
Screen, 
Enroll 
Week 
1 
Week 
12 
Week  
13 
Week 
16 
Week 
20 
Week 
24 
Week 
36 
Week 
48 
N/A 
Permitted window (days) 
 
±2d 
±3d 
±3d 
±3d 
±4d 
±7d 
±7d 
±7d 
N/A 
Clinical Evaluations 
 
 
 
 
 
 
 
 
 
 
Obtain Informed Consent 1 
X 
 
 
 
 
 
 
 
 
 
Review Eligibility Criteria 
X 
 
 
 
 
 
 
 
 
 
Review and Record Medical History 
X 
 
 
 
 
 
 
 
 
 
Review and Record Demographics 
X 
 
 
 
 
 
 
 
 
 
Review Record Prior and Concomitant Meds 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
Physical Exam and Vital Signs 2 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
Safety Evaluations 
 
 
 
 
 
 
 
 
 
 
Record Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Examine injection site and record findings 
X 
X 
X 
X 
X 
 
 
 
 
X 
Blood for Hematology 3: CBC with differential 
X 
X 
 
 
X 
 
 
 
X 
 
Blood for Chemistry Testing 4: Sodium, 
potassium, glucose, BUN, Cr, ALT, Bili 
X 
X 
 
 
X 
 
 
 
X 
 
Serological test 5 
X 
 
 
 
 
 
 
 
 
 
Chest X-ray 
X 
 
 
 
 
 
 
 
 
 
12-lead ECG 
X 
 
 
 
 
 
 
 
 
 
PCR or Antibody test for SARS-CoV-2 
X 
 
 
 
 
 
 
 
 
 
Urine for pregnancy testing (as applicable) 
X 
 
X 
 
 
 
 
 
 
 
Study Related Procedures 
 
 
 
 
 
 
 
 
 
 
Administer vaccine  
X 
 
X 
 
 
 
 
 
 
 
Subject Diary 6 
X 
X 7 
X 
 
X 7 
 
 
 
 
 
VAS Score 
X 
 
X 
 
 
 
 
 
 
 
Collect blood for serum 8 
X 
 
X 
 
X 
X 
X 
X 
X 
 
Collect blood for PBMCs 9 
X 
 
X 
 
X 
X 
X 
X 
X 
 
Estimated blood volume  
 
 
 
 
 
 
 
 
 
 
Maximum blood volume collected 
80 
10 
70 
 
80 
70 
70 
70 
80 
 
# Check the occurrence of adverse events by telephone. 
1 Written Informed Consent must be obtained PRIOR to any study procedures; document that a completed copy has 
been provided to participant.  
2 At enrollment, a full physical exam is performed; height and weight are recorded. At follow-up and unscheduled 
visits, only a targeted physical exam is performed determined by the presence of symptoms and directed to those 
organ systems only.  
3 Blood for Hematology: RBC, hemoglobin, hematocrit, platelet, WBC, neutrophil, lymphocyte, monocyte, eosinophil, 
basophil  
4 Blood for Chemistry Testing: Sodium, potassium, glucose, BUN, Cr, ALT, Bili, Ca, Cl, AST, ALP, CPK, albumin, 
total protein, total cholesterol 
5 Serological test: Hepatitis B, Hepatitis A, HIV, Hepatitis C 
6 Subject diary their responses up to 7 days after vaccination of the investigational product on the clinical trial-related 
record sheet distributed to the investigator. 
7 The investigator collects and reviews the records related to the clinical trial. 
8 For serum, collect 1 x 10 mL red top or serum separator tubes; 
9  For PBMCs, collect 4 x 10 mL ACD tubes; 
 

 
 
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Clinical Protocol 
 
 
 
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Table S4: Schedule of Events (Phase IIa subjects assigned to the placebo group who choose to 
be vaccinated with GLS-5310 at study visit #4: Vaccinations at 0 and 8 weeks) 
Tests and Observations 
Visit 1 
Visit 
2 
Visit 
3 
Tele 
Visit  
Visit 
4 
Visit 
5 
Visit 
6 
Visit 
7 
Visit 
8 
Un-
sched 
Time relative to enrollment 
Screen 
Enroll 
Wk 
1 
Wk 
8 
Wk  
9 
Wk 
12 
Wk 
20 
Wk 
24 
Wk 
36 
Wk 
48 
N/A 
Permitted window (days) 
 
±2d 
±3d 
±3d 
±3d 
±4d 
±7d 
±7d 
±7d 
N/A 
Clinical Evaluations 
 
 
 
 
 
 
 
 
 
 
Obtain Informed Consent 1 
X 
 
 
 
 
 
 
 
 
 
Review Record Prior and Concomitant 
Meds 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
Physical Exam and Vital Signs 2 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
Safety Evaluations* 
 
 
 
 
 
 
 
 
 
 
Record Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Examine injection site and record 
findings 
X 
X 
X 
X 
X 
 
 
 
 
X 
Blood for Hematology 3: CBC with 
differential 
X 
X 
 
 
X 
 
 
 
X 
 
Blood for Chemistry Testing 4: Sodium, 
potassium, glucose, BUN, Cr, ALT, Bili 
X 
X 
 
 
X 
 
 
 
X 
 
Serological test 5 
X 
 
 
 
 
 
 
 
 
 
Record most recent HgbA1c (diabetics 
only) 6 
 
 
 
 
 
 
 
 
 
 
Chest X-ray 
X 
 
 
 
 
 
 
 
 
 
12-lead ECG 
X 
 
 
 
 
 
 
 
 
 
PCR or Antibody test for SARS-CoV-2 
X 
 
 
 
 
 
 
 
 
 
Urine for pregnancy testing (as 
applicable) 
X 
 
X 
 
 
 
 
 
 
 
Study Related Procedures 
 
 
 
 
 
 
 
 
 
 
Administer study drug  
X 
 
X 
 
 
 
 
 
 
 
Subject Diary 7 
X 
X 7 
X 
 
 
 
 
 
 
 
VAS Score 
X 
 
X 
 
X 
X 
 
 
 
 
Collect blood for serum 8 
X 
 
X 
 
X 
X 
X 
X 
X 
 
Collect blood for PBMCs 9 
X 
 
X 
 
X 
X 
X 
X 
X 
 
Estimated blood volume  
 
 
 
 
 
 
 
 
 
 
Maximum blood volume collected 
60 
10 
50 
 
60 
50 
50 
50 
60 
 
 
*  If there are test results for safety evaluation items within 1 week from the first investigational product vaccination 
date, it can be used 
# Check the occurrence of adverse events by telephone. 
1 Written Informed Consent must be obtained PRIOR to any study procedures; document that a completed copy has 
been provided to participant.  
2 At enrollment, a full physical exam is performed; height and weight are recorded. At follow-up and unscheduled 
visits, only a targeted physical exam is performed determined by the presence of symptoms and directed to those 
organ systems only.  
3 Blood for Hematology: RBC, hemoglobin, hematocrit, platelet, WBC, neutrophil, lymphocyte, monocyte, eosinophil, 
basophil  
4 Blood for Chemistry Testing: Sodium, potassium, glucose, BUN, Cr, ALT, Bili, Ca, Cl, AST, ALP, CPK, albumin, 
total protein, total cholesterol 
5 Serological test: Hepatitis B (HBsAb, HBsAg), Hepatitis A (IgG, IgM), HIV, Hepatitis C- HCV RNA testing, if 
necessary 
6 HgbA1c is performed if not available within 3 months prior to enrollment 

 
 
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Clinical Protocol 
 
 
 
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7 Subject diary their responses up to 7 days after vaccination of the investigational product on the clinical trial-related 
record sheet distributed to the investigator. Diaries are reviewed at the relevant visits in the schedule.  
8 For serum, collect 1 x 10 mL red top or serum separator tubes;  
9 For PBMCs, collect 4 x 10 mL ACD tubes; 
 
 

 
 
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Clinical Protocol 
 
 
 
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[Abbreviations and Terms]  
Abbreviations 
Terms 
ACE2 
Angiotensin converting enzyme 2 (receptor binding protein) 
AE 
Adverse event 
ALT 
Alanine aminotransferase 
BAL 
Bronchoalveolar lavage 
BUN 
Blood urea nitrogen 
CBC 
Complete blood count 
COPD 
Chronic obstructive pulmonary disease 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
ERER 
Event requiring expedited reporting 
GMT 
Geometric mean titer 
HBV 
Hepatitis B virus 
HBsAg 
Hepatitis B virus surface antigen 
HCV 
Hepatitis C virus 
HIV 
Human immunodeficiency virus 
IB 
Investigator’s brochure 
ICF 
Informed consent form 
ID 
Intradermal 
IFNγ 
Interferon gamma 
IM 
Intramuscular 
IRB 
Investigation review board 
ITT 
Intention-to-treat 
IUD 
Intrauterine device 
M 
Membrane protein 
MERS-CoV 
Middle East respiratory syndrome coronavirus 
mITT 
Modified intention-to-treat 
NK 
Natural killer 
NP 
Nucleocapsid protein 
NS 
Not stated 
PBMCs 
Peripheral blood mononuclear cells 
PHI 
Personal health information 

 
 
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Clinical Protocol 
 
 
 
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Abbreviations 
Terms 
PI 
Principal investigator 
PID# 
Participant identification number 
PP 
Per-protocol 
PRNT 
Plaque reduction neutralization titer 
PT 
Preferred term 
RBD 
Receptor binding domain 
S 
Spike (coronavirus spike protein) 
SAE  
Serious adverse event 
SAP 
Statistical analysis plan 
SARS-CoV 
Severe acute respiratory syndrome coronavirus 
SARS-CoV-2 
Severe acute respiratory syndrome coronavirus, type 2 
SOC 
System organ class 
SS 
Safety set 
SSC 
Saline sodium citrate 
SUSAR 
Suspected unexpected serious adverse reaction 
WHO 
World Health Organization 
 
 

 
 
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1. 
INTRODUCTION 
This Phase I / II study will examine the safety, tolerability and immunogenicity of the GLS-5310 
DNA vaccine against the Severe Acute Respiratory Syndrome coronavirus, type 2 (SARS-CoV-
2) when administered intradermally (ID) with the JM-11 device to healthy individuals without a 
history of documented SARS-CoV-2 infection.  
1.1 
Background and Rationale 
SARS-CoV-2 is the third highly pathogenic coronavirus identified to cause disease in humans 
since 2002. SARS-CoV caused a total of approximately 10,000 cases worldwide between 2002 
and 2003 with a global mortality rate of 10%. The Middle East respiratory syndrome coronavirus 
(MERS-CoV) was first identified in 2012 and has resulted in fewer than 3,000 cases worldwide 
but with a mortality rate of 36%.  
SARS-CoV-2 emerged in the last months of 2019. as of October 2020 Global case rates have 
exceeded 40 million with greater than 1 million deaths. Many countries are currently experiencing 
a 2nd wave of infection with increasing case rates, hospitalizations, and death rates.  
Currently, greater than 200 vaccine candidates against SARS-CoV-2 have been developed with 
a number advanced to clinical trials 1. Approximately 10 vaccines have been granted emergency 
use authorization in multiple countries. The vast majority of vaccine candidates specifically target 
the coronavirus spike (S) protein 2,3, while others are versions of inactivated viruses and target 
the entire virus 4.  
1.1.1 The SARS-CoV-2 Spike protein as a vaccine target  
The coronavirus S protein has been the dominant antigenic target for SARS-CoV, MERS-CoV, 
and SARS-CoV-2 vaccine design. Our MERS-CoV DNA vaccine, GLS-5300, also targets the S 
protein and has been shown to induce strong antibody and T cell responses in healthy adults 5 6. 
Similarly, most of the SARS-CoV-2 vaccine candidates in pre-clinical and clinical development 
have targeted the coronavirus S protein as a single antigen.  
Previous studies of SARS-CoV vaccine constructs in pre-clinical studies, summarized in the GLS-
5310 Investigator’s Brochure (IB), showed that S-only vaccines were in general not able to induce 
sterilizing immunity in animal models of infection. A similar phenomenon was seen for MERS-
CoV vaccines. SARS-CoV-2 vaccines in development have also shown variable ability to induce 
sterilizing immunity. Rhesus macaques inoculated with the ChAdOx1 vaccine encoding the 
SARS-CoV-2 S protein developed less clinical disease, however, an equal number of animals in 
the vaccine and control groups demonstrated high pulmonary viral load levels 2. In this same 
study, nasal RNA viral loads did not differ between vaccinated and control animals.  A separate 
research group evaluated a series of S protein DNA vaccines 7. While these vaccine constructs 
induced high levels of neutralizing antibodies and T cell responses in Rhesus macaques, 
bronchoalveolar lavage (BAL) samples showed continued viral presence and thus demonstrated 
that non-sterilizing immunity was obtained in 50-75% of animals 7. Nasal swabs from vaccinated 
animals evaluated for the presence of virus showed no difference from control animals. Antibodies 
from vaccinated animals induced antibody dependent neutrophil or NK, or monocyte phagocytosis. 
However, whether this phenomenon correlated with greater viral survival and/or correlated with 
any clinical signs was not reported 7. Finally, an inactivated SARS-CoV-2 vaccine induced high 
levels of binding and neutralizing antibodies in rats and macaques 4. Macaques demonstrated 

 
 
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dose-dependent protection such that animals receiving 3 µg of vaccine had low levels of virus in 
the lung, whereas those inoculated with 6 µg had no detectable virus in the lung, however, virus 
was present in throat swabs regardless of high and low-dose 4. Importantly, vaccinated animals 
still developed moderate pulmonary inflammation on histology 4.  
The coronavirus nucleocapsid (N) protein is also very immunogenic with high levels of antibody 
and T cell responses seen among patients recovered from infection. Moreover, cellular responses 
against the SARS-CoV N have been found to be persistent over years. However, inclusion of N 
as a vaccine antigen may be contraindicated as SARS-CoV vaccines that included this protein 
induced significant immune priming resulting in an intense eosinophilic pneumonitis whereas the 
viral S did not 8,9. A commentary by Hotez et al. cited the N as the inciting antigenic target inducing 
a Th17 immune response leading to immune priming 10. Consensus recommendations of the 
Coalition for Epidemic Preparedness and Innovation (CEPI) and the World Health Organization 
(WHO) similarly recommend avoidance of the SARS-CoV-2 N in vaccine constructs 11. 
To summarize, while the SARS-CoV-2 S protein is an appealing target, it may not induce 
sterilizing immunity when used as a sole vaccine antigen and inclusion of the coronavirus N 
protein may be contraindicated in a vaccine. In the next section we discuss our rationale and the 
merits of including ORF3a as a second vaccine antigen.  
1.1.2 The SARS-CoV-2 ORF3a protein as a vaccine antigenic target  
Studies of patients recovered from SARS-CoV infection have shown good correlation between 
the presence of binding and neutralizing antibodies 12. Antibodies against the SARS-CoV S 
protein were relatively short-lived with a half-life of about 6 weeks and a decay more rapid in those 
with more severe disease 12. In contrast, T cell responses were persistent and long-lived to at 
least 4 years with the greatest magnitude of responses against the replicase, S, ORF3a, ORF7, 
and NP 13. T cell responses against the S, ORF3, membrane (M), and S were the most prevalent 
among convalescent patients. A DNA vaccine against the SARS-CoV ORF3a was shown to be 
safe and able to induce high levels of humoral and cellular immune responses in mice 14.  
For SARS-CoV-2, both S and ORF3a have similarly been shown to be potent inducers of T cell 
responses in recovered patients 15, and its inclusion in our vaccine is primarily as a second 
immunogen to strengthen the overall T cell response. Importantly, T cell responses against S and 
ORF3a were the most prevalent among patients recovered from natural SARS-CoV-2 infection 
and reactivity was observed among the HLA-restricted epitopes that are most prevalent in the US 
and Korean populations 16. 
In addition to the lack of sterilizing immunity induced by S protein vaccines, a number of recent 
reports raise additional potential concerns as to the reliance on vaccines that only target the S 
protein. A novel S mutation, D614G, that has been identified among persons infected with SARS-
CoV-2 enhances viral infectivity and is associated with the loss of neutralizing activity in 
approximately 7% of such individuals 17. Second, the SARS-CoV-2 S protein has been shown to 
undergo conformational changes within the acidic environment of endosomes, which abolishes 
the effects of bound neutralizing antibodies 18 – thus raising the concern that neutralizing 
antibodies may be ineffective or less effective than predicted by in vitro assays.  
Finally, antibodies against SARS-CoV-2 decline quickly after infection, often becoming 
undetectable in as short as 90 days post-infection 19, suggesting the need for T cell 
immunogenicity for a long-lasting effect. Two recent studies provide critical evidence that ORF3a 
is a major immunogen of SARS-CoV-2 within the immediate period post-infection 15,16. T cell 

 
 
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Clinical Protocol 
 
 
 
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responses against ORF3a were present in 80-100% of sampled convalescent individuals 16. 
Perhaps even more critical is that only S and ORF3a contained HLA A*02:01 and A*24:02 
restricted epitopes, highly prevalent HLA haplotypes in the US and Korea 20.  
The GLS-5310 vaccine was designed to target the S and ORF3a viral antigens of SARS-CoV-2 
to generate robust immune responses from both B and T cells that may work synergistically to 
increase vaccine effectiveness. Pre-clinical studies of GLS-5310 are detailed in the IB. Pre-
clinically, we have shown that each antigen is independently expressed from our DNA plasmid 
vaccine construct in vitro, and together are immunogenic in vivo with each inducing strong B and 
T cell immune responses, including high levels of binding and neutralizing antibodies, following 
intradermal administration of GLS-5310 with the JM-11device. Moreover, pre-clinical data has 
demonstrated immune responses equal to or greater than those elicited with use of 
electroporation. 
1.2 
Investigational Agent 
GLS-5310 DNA plasmid vaccine contains a single plasmid, pGO-1002 (Figure 1.2-1), formulated 
at 6 mg/ml in 1X saline sodium citrate (SSC) buffer.  
Figure 1.2-1: pGO-1002 plasmid  
1.3 
Dose and Regimen Rationale 
For this Phase I / II study, GLS-5310 will be given at one of two dose levels (0.6 mg and 1.2 mg) 
administered intradermally (ID) by injection followed by suction using the JM-11device. Vaccine 
will be administered at baseline and again at either 8 or 12 weeks.  
First of all, the factors to consider for setting the capacity are as follows. 
The DNA vaccine is not directly vaccinated with a viral antigen that induces a vaccine immune 
response, but if it is vaccinated in the form of DNA, which is a gene encoding the antigen, it is 
delivered into cells, and then the antigen is produced and secreted from the DNA through 
transcription and translation processes. Therefore, the immune response of the vaccine does not 
increase directly in proportion to the administered dose. Therefore, rather than setting the clinical 
dose through animal experiments like the existing vaccine, the standard dose is set in 
consideration of the administration route based on the final concentration of the manufactured 
pGO-1002 

 
 
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DNA vaccine, and the optimal dose is increased or decreased through clinical trial. It is common 
to find. For example, the maximum concentration of our DNA vaccine is 6-10mg/mL, and in 
general, the intramuscular vaccination volume is 1mL and the intradermal vaccination volume is 
0.1mL. Applying this, the standard dose for clinical trials is 6-10 mg dose for intramuscular 
vaccination, and 0.6 to 1.0 mg dose for intradermal vaccination. 
The dose levels chosen are consistent with the dosage range for our prior MERS-CoV DNA 
plasmid vaccine, GLS-5300, studies, and the above contents. In the Phase I study of GLS-5300, 
vaccine was administered IM at doses of either 0.6, 2, or 6 mg (NCT02670127 5) and in the Phase 
Ib/IIa study GLS-5300 was administered ID at doses of either 0.3 or 0.6 mg (NCT03721718 6). 
Results of these two studies demonstrated no clear dose effect for the GLS-5300 vaccine given 
over a 10-fold range from 0.6 mg to 6 mg. In addition, as a result of pre-clinical efficacy evaluation 
of GLS-5310, the level of vaccine immune response induced by the use of an electroporator and 
a suction was similar. Therefore, although the clinical study of the MERS DNA vaccine used 
electroporation, it can be used as the basis for the dose setting of the GLS-5310 clinical study. 
Therefore, when the maximum concentration of the drug product of GLS-5310 is 6mg/mL and 
0.1mL, which is the volume for intradermal vaccination, is applied, the standard dose becomes 
0.6mg. The second dose was set to a 1.2mg dose, which was doubled from the 0.6mg dose, 
using the results of the clinical study of the MERS DNA vaccine, and the optimal dose will be 
selected through a phase 1 study of this clinical trial protocol. 
To select the vaccination interval of GLS-5310, an interim analysis of the phase 1/2a clinical study 
of the MERS DNA vaccine (GLS-5300) was performed. The immune responses in the 3 times 
vaccination group (0-4-12 weeks)  and the 2 times vaccination group (0-8 weeks) were compared. 
The binding antibody titers and neutralizing antibody titers at the time point of 8 weeks (after the 
second dose and after the first dose, respectively) of the 3 times vaccination group and the 2 
times vaccination group were similar. At 12 weeks (all after the second dose), the 2 times 
vaccination group was rather higher.  
As a result, in the case of DNA vaccine, it was confirmed that setting the interval between single 
vaccination and 2 times vaccination of 8 weeks or more could induce a more effective vaccine 
immune response, and this was applied to GLS-5310 vaccine. 
  
 
1.3.1 Function of Suction after intradermal administration of DNA vaccine 
For the purpose of researching gene therapy products, when a plasmid, a naked DNA encoded 
with a target gene, was administered in the body and then suction, the result of protein expression 
from the target gene at that injection site has been studied and published several times. At this 
time, the plasmid itself can be delivered intracellularly when administered into the human body, 
but when suction is applied, it can be seen that it induces physical stimulation at the injection site 
of administration and affects gene expression in the plasmid. The suction device is an industrial 
product device for beauty or an equivalent or higher device that simply applies suction pressure. 
The main component of DNA vaccines is a plasmid containing a gene encoding an antigen of a 
virus that causes disease. When the DNA vaccine is administered intradermally, the vaccine 

 
 
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Clinical Protocol 
 
 
 
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immune response is induced by antigens generated from the DNA vaccine. At this time, when the 
inhalation pressure used in the gene therapy research is applied, it provides a physical stimulation 
to the intradermal cells at the injection site, thereby giving a secondary effect of enhancing the 
vaccine immune response. 
 
1.4 
Risk/Benefit Assessment 
In accordance with the International Conference on Harmonization (ICH), this study has been 
designed to minimize the risk to study participants. 
This study of GLS-5310 vaccine is designed to determine whether the vaccine can induce immune 
responses in an effort to prevent disease from SARS-CoV-2. The adverse effects of GLS-5310 
vaccine are unknown, however, GLS-5310 is similar to other GeneOne Life Science vaccines. 
These include Phase I and Phase Ib/IIa studies of GLS-5300 DNA vaccine against MERS-CoV. 
Results of the Phase I study of GLS-5300 have been published 5 with no vaccine associated 
serious adverse events (SAEs) and most common adverse events (AEs) were related to 
electroporation-based administration. Preliminary results of the GLS-5300 Phase Ib/IIa study 
were presented at the May 2020 meeting of the American Society for Gene and Cell Therapy 6 
with no vaccine associated SAEs. Treatment assignment will be unblinded at visit 4 and 
participants and site personnel informed of vaccine or placebo status. Subjects that had been 
assigned to placebo will be offered vaccination with GLS-5310 clinical trial drugs. However, the 
information on safety and efficacy may be limited if an approved or an emergency use authorized 
vaccine is administered after vaccination of the clinical trial study drug.  
 
2. 
HYPOTHESIS AND STUDY OBJECTIVES 
2.1 
Hypothesis 
GLS-5310 DNA vaccine administered ID will be well tolerated and will elicit immune responses 
against the SARS-CoV-2 vaccine antigens. 
2.2 
Primary Objectives and Outcome Variables – Phase I & II 
• 
Evaluate the safety and tolerability of the GLS-5310 DNA vaccine delivered ID  
• 
Determine the post vaccination binding antibody responses induced by GLS-5310 DNA 
vaccine 
2.3 
Secondary Objectives and Outcome Variables – Phase I & II 
• 
Determine the T cell responses induced by GLS-5310 DNA vaccine 
• 
Determine the neutralizing antibody response induced by GLS-5310 
• 
For those with incident SARS-CoV-2 infection, determine the difference in moderate or 
severe pulmonary disease relative to treatment group 
2.4 
Exploratory Objectives 
Phase I exploratory objectives 
• 
Determine IgG antibody responses after a single dose of vaccine related to treatment arm 
• 
Determine whether passive transfer of human serum following ID vaccine administration 
can protect against pulmonary infection from SARS-CoV-2 challenge in an animal 
infection model 

 
 
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Clinical Protocol 
 
 
 
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Phase II exploratory objectives 
• 
Determine the persistence of immune responses following vaccination with GLS-5310 in 
long-term follow-up visits 
• 
Determine the extent of immune boosting responses for participants who are seropositive 
at baseline following vaccination with GLS-5310 
• 
Determine whether immune responses to GLS-5310 of participants age 66 to 85 years 
differ from those age 65 years and younger.  
 
3. 
STUDY DESIGN 
This Phase I / II study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA 
vaccine. 
The Phase I study is an open-label, dose escalation study to assess two dose levels of GLS-5310 
DNA vaccine (0.6 and 1.2 mg) and given via two vaccination regimen (0-8 weeks and 0-12 weeks). 
Participants will be randomized to one of the three treatment arms. GLS-5310 will be administered 
via intradermal (ID) injection using the Mantoux technique followed by suction applied over the 
vaccination site using the JM-11device. The primary outcome measures are the safety and 
tolerability of GLS-5310 given ID with JM-11 and binding antibody responses elicited by 
vaccination. Secondary outcome measures are the T cell responses elicited to vaccine antigens 
and neutralizing antibody titers.  
Dose escalation within the Phase I portion of the study will occur as follows. Study arm 1a (0.6 
mg per vaccination) will be vaccinated and followed to the Week 1 safety visit. If no vaccine-
associated severe adverse events (SAEs) have been documented, then enrollment into study 
arms 1b and 1c (1.2 mg per vaccination) will occur in a randomized manner. An interim analysis 
will occur after visit 4, four weeks after the 2nd vaccination to assess safety and binding antibody 
responses.  Escalation to Phase II will occur based on this analysis. The choice of regimen for the 
Phase II study will be determined after review of study objectives. 
 
The Phase IIa study is designed as a randomized, double-blind, placebo-controlled study with 
only a single active study drug arm. Subjects will be randomized to receive either placebo or GLS-
5310 vaccine in a 1:2 ratio. The primary and secondary goals of the Phase II study are the same 
as the Phase I study. An interim analysis will be performed at Visit 4, one month after the final 
vaccination. The study will be unblinded at the post-vaccination visit (study visit 4) at which time 
subjects will be informed of their treatment assignment. Subjects who were assigned to the 
placebo group will be offered to be vaccinated with GLS-5310. Subjects assigned to the placebo 
group who choose to be vaccinated with GLS-5310 will be followed for a year from 1st GLS-5310 
vaccination (Table S4); subjects assigned to the placebo group but who decline vaccination with 
GLS-5310 will be followed for a year from study entry as per the original study protocol. 
 
[Sub-studies]  
A sub-study will be included within the Phase IIa portion of CoV2-001 clinical trial.  
Participants > 66-85 years of age: up to 30 persons will be recruited to examine whether immune 
responses in this age group are similar or different from those age < 66-85 years of age.   

 
 
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The above subgroup will be randomized as part of the main study, and not separately randomized. 
At randomization, 5 subjects age 65 to 74 years of age will be recruited as a sentinel group to 
confirm the safety of the older age group. When the sentinel group is vaccinated with the clinical 
trial drug, the vaccination is carried out at an interval of at least 24 hours between each subject. 
Once five subjects aged 65 to 74 years have been enrolled into the sentinel group, if no adverse 
drug reactions that meet study criteria for stopping vaccination of a clinical investigational drug 
have not been observed, then registration of the remaining older age cohort subjects can proceed. 
 
Exploratory goals of the Phase I study will examine (1) the effect of a single vaccination to induce 
IgG antibodies, and (2) whether passive transfer of immune serum from vaccinated study 
participants will protect against disease in an animal challenge model of SARS-CoV-2 infection. 
Exploratory goals of the Phase II study will examine whether (1) SARS-CoV-2 seropositive 
individuals at baseline experience boosting of their immune responses with vaccination and will 
also explore (2) the durability of vaccine induced immune responses through the assessments at 
long-term follow up visits, (3) immune responses differ for those who are age 66 to 85 years older 
relative to those age 65 and younger.  
Serologic immune responses will be determined by ELISA testing with the SARS-CoV-2 spike (S) 
and ORF3a proteins as antigen targets. T cell responses will be determined by ELISPOT assays 
using overlapping 15-mer peptides spanning the entirety of the S and ORF3a proteins. 
Neutralizing antibody responses will be determined either by live virus, pseudovirion, or binding 
inhibition assay(s). 
 
 
[CoV2-001 clinical trials scheme] 

 
 
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A summary of the vaccination evaluation is presented in Tables S2, S3 and S4. 
Safety assessment: All subjects will be monitored for 
■ Local and systemic adverse events at each study visit. 
■ Laboratory-related adverse events after each vaccination. 
Immune Response Assessment: 
The test will assess cellular and humoral immune responses in blood samples collected after 
baseline and vaccination according to Table S2. 
 
The duration of this clinical trial is as follows. 
About 20 months from the date of approval of the clinical study by the Ministry of Food and Drug Safety 
and the Institutional Review Board 
- Recruitment period for test subjects: about 5 months 
- Clinical trial period for each subject: at least 48 weeks 
 
3.1 
Interim Safety Monitoring 
As part of the Phase I study, two interim safety reviews will be performed. A review of AE’s and 
laboratory results will occur after all subjects in Study Arm 1a (0.6 mg) have received their 1st 
dose of vaccination and have completed the Week 1 safety visit. A formal Interim Analysis will be 
performed after study visit 4, four weeks after the 2nd vaccination to review AE’s and binding 
antibody responses to select the vaccination regimen to be used for the Phase II study.  
Subject diaries to be reviewed at the next visit after vaccination are distributed to the subjects, 
and symptoms of local and systemic reactions are collected and documented 7 days after 
vaccination. 
As part of the Phase IIa study, an interim safety review will be performed after all participants 
have completed through the 4th study visit corresponding to the post-immunization visit after the 
primary vaccination series. Safety and immunogenicity will be determined and compared between 
groups as well as for the subgroup who are age 66 to 85.  
 
4. 
SELECTION AND ENROLLMENT OF PARTICIPANTS 
4.1 
Recruitment of Participants 
Healthy adult volunteers will be recruited for the study.  
4.2 
Inclusion Criteria 
1. Age greater than 19 to 85 years of age (Phase I will be restricted to an upper age limit of 
50 years of age); Phase IIa will allow enrollment of 30 persons 66 to 85 years of age.  
2. Able to provide informed consent  

 
 
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3. Able and willing to comply with study procedures 
4. For women of child-bearing potential, able and willing to utilize an approved form of 
pregnancy prevention through to 4 weeks post-boost vaccination. 
Approved forms of pregnancy prevention are as follows,  
① Hormonal contraceptives (e.g., oral progesterone single or estrogen-progesterone 
complex, transdermal delivery type contraceptives, depot injections, etc.) 
② Implantation of intrauterine devices or intrauterine systems 
③ Double blocking method [male physical blocking method (eg. male condom) and female 
physical blocking method (eg. cervix cap, contraceptive diaphragm, contraceptive sponge] 
are used in combination, and spermicide is used together. The use of condoms in all cases 
is not recommended as damage from physical friction may be less effective than expected 
contraception.) 
④ Surgery and operation status such as tubal ligation (resection), hysterectomy, and 
vasectomy (resection) 
 
4.3 
Exclusion Criteria 
1. 
Current or planned pregnancy through to 4 weeks post-boost vaccination for women of 
childbearing potential 
2. 
Currently breastfeeding 
3. 
Current or past participation in a coronavirus (MERS-CoV, SARS-CoV-2) vaccine study 
4. 
Administration of an investigational agent within 6 months of the 1st dose 
5. 
Administration of a vaccine within 28 days prior to the 1st dose 
6. Administration of immune globulin or blood-derived medicinal product within 16 weeks of 
enrollment 
7. 
Administration of an anti-TNFα inhibitor such as infliximab, adalimumab, etanercept, or 
rituxumab within 24 weeks from enrollment  
8. 
Current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater, 
dexamethasone of 3 mg or greater, or equivalent dose of other systemic corticosteroids 
9. Administration of any Immunosuppressive Drug or Immunomodulator within 3 months of 
the 1st dose 
10. History of bone marrow transplantation  
11. Current or planned chemotherapy treatment for hematologic or solid tumor during study 
period or treatment during the 5 years prior to enrollment 
12. Respiratory disease (ex. Asthma, Chronic obstructive lung disease) that is uncontrolled 
per their treating physician 
13. Cardiovascular disease (ex. myocardial ischemia, congestive heart failure, 
cardiomyopathy, clinically significant arrhythmia) that is uncontrolled per their treating 
physician 
14. Uncontrolled Hypertension (Systolic pressure >150mmHg or Diastolic pressure 
>95mmHg) 
15. Uncontrolled Diabetes   
16. Severe allergic reaction or anaphylactic reaction after vaccination in the past  

 
 
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17. Immunosuppresion including immunodeficiency disease or family history  
18. Positive of serum test at screening of Hepatitis B surface antigen, Hepatitis A IgM, HIV, 
or Hepatitis C. Those who are Hepatitis C seropositive are allowed to participate if thtey 
have a negative HCV RNA test.   
19. Baseline screening lab(s) with Clinically Significant abnormality (Grade 2 or higher) 
20. Serious adverse reaction to a drug containing Investigational Product (GLS-5310) or 
other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-
inflammatory disease control, etc. or an allergic history 
21. History of hypersensitivity to vaccination such as Guillain-Barre syndrome  
22. History of PCR-confirmed infection with SARS-CoV-2 or positive SARS-CoV-2 antibody 
or PCR test at screening  
23. Subjects who have been contact with COVID-19 infections in the past prior to 
administration, have been classified as COVID-19 confirmed patients, medical patients 
or patients with symptoms or have been identified with SARS and MERS infection 
history in the past 
24. Acute over 37.5℃ fever, cough, difficulty breathing, chills, muscle aches, headache, sore 
throat, loss of smell, or loss of taste within 72 hours prior to administration  
25. Healthcare workers participating in the medical examination of patients infected with 
COVID-19 or high-risk individuals who are likely to be occupationally exposed to SARS-
CoV-2 
26. Not willing to allow storage and future use of samples for SARS-CoV-2 related research 
27. Prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness 
28. Any illness or condition that, in the opinion of the investigator, may affect the safety of 
the subject or the evaluation of a study endpoint 
29. Receipt of a vaccine to prevent COVID-19 infection 
 
 
4.4 
Discontinuation/Withdrawal of Study Participants 
Participants will be considered to have completed the study when he/she completes all scheduled 
study treatments and follow-up visits. If a participant discontinues the study at any time after 
enrollment, but prior to the final scheduled study visit, the investigator will make every effort to 
have the participant complete all assessments. At a minimum, study participants will be 
encouraged to complete all procedures included in the final study visit should they elect to 
terminate early. All data collected up to the time of early termination will be used for final analyses 
except as noted below. Categories of early study termination are defined below: 
• 
Voluntary withdrawal from the study: the participant verbalizes or states in writing their 
desire to withdraw from the study. Data already collected remains as part of the study.  
• 
Dropout : the participant has a potentially life-threatening adverse event, grade 4 adverse 
event, or death that is judged to be related to the vaccination of the investigational product, 
or anaphylaxis of grade 3 or higher that is considered to be related to the vaccination of 
the investigational product is reported. 
• 
Withdrawal of consent: When the subject makes a verbal or written request to cease 
participation in the clinical trial and also withdraws consent to the use of all clinical trial 
data. If the subject agrees to the use of clinical trial data already collected after discussion 

 
 
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with the investigator, the subject is classified as “Stop participating in voluntary clinical 
trials”. 
• 
Lost to follow-up: the participant terminates, does/will not return to complete study visits 
and cannot be located, or does not respond to multiple attempts at contact.  
• 
Major protocol violation: the participant failed to adhere to protocol requirements. Such 
events will be discussed on a case-by-case basis between the Medical Monitor and the 
site Principal Investigator (PI) to determine whether these events constitute a deviation 
that requires removal of the participant from the study and/or non-use of study data.  
• 
Adverse event (Adverse Drug Reaction): clinical or laboratory events that in the medical 
judgement of the investigator are grounds for discontinuation for the best interest of the 
participant. This includes serious and non-serious adverse events regardless of relation 
to study drug.  
• 
Death: the participant died. 
 
4.5 Clinical trial termination and early termination 
In this clinical trial, the termination of the clinical trial of the last participant is defined as the 
termination of the entire clinical trial.  
Meanwhile, the sponsor may early terminate the clinical trial site or the clinical trial at a specific 
clinical site (discontinue or stop of the clinical trial). The reasons for early termination of the 
clinical trial by the sponsor include, but are not limited to: 
1) In case of failure to register the target number of participants in all or a specific clinical site 
2) In case of occurrence of efficacy/safety information that may have a significant impact on 
the continuation of the clinical trial 
① In case of serious adverse event or grade 4 or higher adverse event related to 
vaccination of investigational product 
② In the case of more than 20% of the participants who occurred grade 3 or higher 
adverse events continuing for one or more days in each cohort 
3) If there is a violation of good clinical practice (GCP), clinical trial protocol or contract by 
the clinical trial site or investigator that interferes with continuation of the clinical trial 
4) Other administrative reasons that may have a significant impact on the continuation of the 
clinical trial 
Investigator and Institutional Review Board may be terminated in early stage according to the 
information collected or observed during the clinical trial if it is judged that the benefits that can 
be obtained by individuals and society do not exceed the risks and inconveniences or cannot 
justify them.  
In the case of early termination of the clinical trial, the following is required. 

 
 
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1) If the investigator terminates the clinical trial prematurely without prior agreement with the 
sponsor, the investigator immediately informs the sponsor and the IRB of this fact and submits a 
detailed reason for early termination and suspension. 
2) If the sponsor terminates or early terminates the clinical trial, the investigator immediately 
informs the IRB of this fact and submits a detailed reason for the early termination or suspension. 
3) If the IRB early terminates or suspends the clinical trial, the investigator immediately informs 
the sponsor of this fact and submits a detailed reason for the early termination and suspension. 
4) In case the relevant clinical trial is prematurely terminated or suspended according to the 
provisions of 1) to 3), the investigator immediately informs the subject of this fact so that 
appropriate measures and follow-up can be made. 
 
5. 
STUDY PROCEDURES AND ADMINISTRATION PLAN 
5.1 
Overall Procedure 
This Phase I / II study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA 
vaccine. 
The Phase I portion of this study is an open-label, dose escalation study to assess two dose levels 
of GLS-5310 DNA vaccine (0.6 and 1.2 mg) as part of two vaccination regimens (0-8 weeks and 
0-12 weeks). After enrolling study arm 1a (0.6 mg), participants will be randomized to study arms 
1b and 1c. GLS-5310 will be administered via intradermal (ID) injection using the Mantoux 
technique followed by suction applied over the vaccination site using the JM-11 device. The 
primary outcome measures are (1) the safety and tolerability of GLS-5310 given ID with JM-11 
and (2) binding antibody responses elicited by vaccination. Secondary outcome measures are 
the (3) T cell responses elicited to vaccine antigens and (4) neutralizing antibody titers. 
Exploratory goals of the study are to determine the IgG antibody responses after a single 
vaccination relative to treatment arm and whether passive transfer of immune serum can protect 
animals from pulmonary disease.  
Dose escalation within the Phase I portion of the study will occur as follows. Study arm 1a (0.6 
mg per vaccination) will be vaccinated and followed to the Week 1safety visit. If no vaccine-
associated severe adverse events (SAEs) have been documented, then enrollment into study 
arms 1b and 1c (1.2 mg per vaccination) will occur in a randomized manner. Phase I subjects 
complete Visit 4, an interim analysis to evaluate safety and binding antibody response is 
performed. The assessment of adverse events is performed after visit 1 to study arm 1a. The 
interim analysis are performed after visit 4 for study arms 1a, 1b, and 1c of the Phase I, and after 
visit 4 for study arms 2a and 2b of the Phase IIa. In order to advance to Phase IIa, the 
seroconversion rate for the antibody binding between the study arms is >70%, and the incidence 
of serious adverse reactions (Grade 3 or higher) related to the investigational drug should be no 
more than 1 case. In addition, the safety and immunogenicity results are evaluated on the data 
and safety monitoring board (DSMB). Escalation to Phase IIa will occur based on the interim 
analysis.  
The Phase IIa portion of this study is designed as a randomized, double-blind, placebo-controlled 
study with only a single active study drug arm. Subjects will be randomized to receive either 

 
 
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placebo or GLS-5310 vaccine in a 1:2 ratio. Included are those who are 66 to 85 years of age 
(restricted to 30 persons total) and meet inclusion and exclusion criteria as specified. The latter 
will not be separated from the overall randomization schema.  
 
5.2 
Administration of GLS-5310 vaccine 
ID vaccine administration with JM-11 is performed by first administering vaccine (0.1 mL) 
intradermally via Mantoux injection with a 1 mL tuberculin syringe with a 25 or 26 gauge needle 
(Figure 5.2-A) that generates a bleb or “bubble” in the skin. It is important that the needle angle 
be very shallow as shown in the photo. After injection, a clean tip is applied on the JM-11 device, 
the opening of the tip of the JM-11 device (Figure 5.2-1b) is applied over the bleb, encircling as 
much of the bleb as possible. The JM-11 device is then turned ON by pressing the button and 
held in place while suction is applied.  The JM-11 device will turn off automatically after 30 
seconds. After use, the tip is discarded, the device cleaned with an alcohol wipe, and then placed 
into a plastic bag and labelled with the participant’s name. For this study, devices will NOT be 
shared between participants.  
 
Figure 5.2-1 A) Example of ID Mantoux injection and B) JM-11device. 
Following vaccine administration, the participant will be asked to assign a VAS score for the 
administration event itself and again at 15-20 min.  
 
5.3 
Concomitant Treatment 
5.3.1 Allowed Concomitant Treatment  
Except for Prohibited Concomitant Treatment (Section 5.3.2), other than investigational products 
(drugs and non-drugs) can be used at the discretion of the investigator if medically necessary. 
5.3.2 Prohibited Concomitant Treatment  
The following concomitant treatment affecting/expecting to affect the efficacy and safety 
evaluation of the investigational product should be prohibited during the 4 weeks after the last 
vaccination, and some treatments from before participation in the clinical trial.  
The drug treatment corresponding to the prohibited concomitant treatment is as follows. 
- Other vaccines except investigational product (within 28 days before first administration 
of investigational product).  

 
 
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- Immunoglobulin or blood-derived drug (within 16 weeks before registration for clinical 
trial) 
- Anti-TNFα inhibitors such as Infliximab, adalimumab, etanercept or anti-CD20 mAb 
(within 24 weeks prior to clinical trial registration) 
- Prednisone 20 mg, dexamethasone 3 mg or more systemic corticosteroids or other 
systemic corticosteroids in equivalent doses (within 7 days before administration of clinical 
trial drug) 
- Immunosuppressant or immunomodulator (within 3 months before administration of 
clinical trial drug) 
-Chemotherapy 
 
6. 
STUDY PRODUCT 
6.1 
Investigational Product 
GLS-5310, the investigational vaccine used in this study, contains a DNA plasmid that encodes 
the SARS-CoV-2 spike (S) and ORF3a proteins and is formulated in SSC buffer. GLS-5310 will 
be supplied sterile, in clear glass vials with a recoverable volume of 0.3 mL.  
 The placebo used in the Phase IIa consists only of SSC buffer that does not contain the active 
ingredient, the plasmid, and is supplied in a clear glass vial with a practical amount of placebo of 
0.3 mL. 
Table 6.1-1 summarizes the ingredients and amounts of vaccines and placebo for clinical trials. 
 
Table 6.1-1 Summarize the ingredients and amounts of vaccines and placebo 
 
Investigational Product 
Placebo 
Drug 
Substance 
(active 
ingredient) 
pGO-1002 
(SARS-CoV-2 Spike, ORF3a  Protein expressed 
plasmid) 
- (no active ingredient) 
Diluent 
Sterile saline sodium citrate (SSC) buffer 
Sterile saline sodium citrate 
(SSC) buffer 
Amount 
1.8mg 
- (no active ingredient) 
Volume 
0.3mL 
0.3mL 
 
 

 
 
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6.2 
Packaging and Labeling  
Study product will be labelled as shown in Table 5.2-1.  
Investigational products are labeled with whether the vial contains the GLS-5310 DNA vaccine or 
SSC placebo, as shown in Table 5.2-1.  
 
 
Table 6.2-1. Study drug product labels (for Phase I) 
Biologic Product/ Placebo 
Sample Label 
GLS-5310  
 
GLS-5310 [6 mg/ml] 
0.3 mL/Vial Single Use Vial 
Lot: GLS-5310.xxxxx 
Date of Manufacture: DD MMM YYYY 
Final Retest Date DD MMM YYYY 
Store at  2 - 8ºC 
CAUTION New Drug – Limited by 
Federal Law to Investigational Use 
GeneOne Life Science, Inc.    
SSC 
SSC 
0.3 mL/Vial Single Use Vial 
Lot: xxxx.xxxxx 
Date of Manufacture: DD MMM YYYY 
Final Retest Date DD MMM YYYY 
Store at  2 - 8ºC 
CAUTION New Drug – Limited by 
Federal Law to Investigational Use 
GeneOne Life Science, Inc.   Rev 000 
 
For the Phase IIa portion of the study, the unblinded site pharmacist will dispense filled syringes 
to blinded study personnel that are labelled with only the subject ID# to maintain treatment blind. 
6.3 
Handling of Study Drug 
Study drug will be stored at 2 - 8°C in a secure area according to local regulations. Refrigerators 
are required to have temperature monitoring and study staffs are required to maintain temperature 
monitoring logs.  
6.4 
Dispensing of Study Drug 
It is the responsibility of the Investigators that study drug is dispensed only to study participants. 
Authorized personnel are the only ones to dispense product according to local regulation.  
Study drug will be drawn up into syringes for ID injection. The syringes should be directly labelled 
with the participant identification number and date and time filled, and the syringes or cartridge 
put into a labelled envelope. Study drug should be administered within 6 hours from when study 
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6.5 
Precautions with Investigational Medicinal Product 
Investigational agent is to be administered only to participants who have completed informed 
consent for this clinical study.  
6.6 
Preparation of Investigational Product 
Non-Luer lock TB tuberculin syringes will be loaded with 0.1 mL of GLS-5310 vaccine. For 
participants who are to receive vaccine at a 0.6 mg dose, a single tuberculin syringe will be filled 
with 0.1 mL of vaccine. For participants who are to receive vaccine at 1.2 mg dose, two tuberculin 
syringes will be filled to 0.1 mL. The syringes should be labelled with the participant ID#, date, 
and time filled.  
6.7 
Record of Investigational Product Disposition at Site 
Investigators 
should 
maintain 
and 
manage 
the 
latest 
records 
of 
storage, 
distribution/return/disposal of investigational drugs at each site. Records and logs must comply 
with applicable regulations and guidelines and include the following: 
• Quantity in storage at the designated place after receipt 
• Quantity currently stored in the designated location 
• Label identification number or batch number and expiration date 
• Initials and dates of the person in charge of inventory/delivery of each investigational drug 
• Quantity issued to each subject, including a unique subject identification number. 
• Quantity transferred to another location/site for delivery or storage 
• If applicable, the quantity discarded by the laboratory. 
 
6.8 
Return and Destruction of Investigational Product 
Once monitoring of Investigational Products is completed by GeneOne or its designee, pharmacy 
will destroy any remaining investigational product. Pharmacy will document destruction of used 
and/or unused vials on the pharmacy logs. 
 
6.9 
Use of JM-11 
JM-11 is a cosmetology device or an equivalent or higher device to apply mild suction. 
There is no need to receive specialized training because JM-11 is brought into contact with the 
bleb formed after intradermal administration of GLS-5310. The operation of the device is in 
accordance with Section 5.2. 
 
6.9.1 Purpose of use and principle of operation 
When GLS-5310 is administered intradermally and aspirated by touching the disposable sterile 
tip of JM-11 to the blister formed after intradermal administration, physical stimulation is delivered 

 
 
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to the intradermal cells of the injection site, thereby enhancing the vaccine immune response. The 
physical stimulation caused by this suction is composed of a slight shear force and a compressive 
force that adsorbs the skin, so there is no safety concern such as skin damage. 
 
6.9.2 Information of JM-11 
- 
-Product # : JM-11 
-Manufacturer : Qubist 
-Suction pressure and operation time : 65kPa, 30 sec 
-Device  
 
- Disposable sterile suction tip 
 
    
 
 
6.9.3 Education and qualification 
Intradermal administration and suction procedures do not require qualifications, but the sponsor 
conducts training to the investigators in advance. 
 
 

 
 
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6.10  Device Accountability  
Sites will document the number of each type of device received and lot number. Each participant 
will be assigned a JM-11device, such that devices are not to be used on multiple participants. 
After the 1st vaccination, the sponge protector is removed and the sponge replaced, the tip is 
removed and discarded, the device cleaned with an alcohol wipe, and the device placed into a 
plastic bag and labelled with the name of the participant. The same device is to be used for the 
2nd vaccination with a new tip applied, after which processing is the same. GeneOne will instruct 
the site in the disposition of the devices after the study.  
 
7. 
STUDY PROCEDURES AND TREATMENTS 
7.1 
Procedures by Visit (also see Tables S2 and S3) 
7.1.1 Visit 1: Determine eligibility, obtain informed consent, enrollment, 1st vaccination 
Prospective study participants will be assigned a unique participant identification number (PID#), 
and then interviewed to determine study eligibility.  
Those who meet study criteria will complete an informed consent and be enrolled into the study 
to complete the following procedures:  
• 
Review and record medical history (last 24 weeks) 
• 
Review and record participant demographics  
• 
Review and record prior and concomitant medications in past 24 weeks 
• 
Perform and record physical examination and vital signs 
• 
Record height and weight 
• 
Collect blood for hematology and chemistry safety labs (baseline values) 
• 
Collect blood for serological testing (Hepatitis B, Hepatitis A, HIV, Hepatitis C) 
• 
Chest X-ray test 
• 
12-Lead ECG test 
• 
PCR or Antibody screening test (SARS-CoV-2) 
• 
Record most recent HgbA1c (diabetics only) 
• 
Collect blood for immunology testing (serum and PBMCs baseline values) 
• 
Collect urine for pregnancy testing (women of childbearing potential) 
• 
Administer study drug (GLS-5310 or placebo depending on randomization results) 
• 
Perform VAS score and record 
• 
Distribution of subject diary after vaccination 
• 
Check whether or not immediate adverse events (anaphylaxis-related) occur within 30 
minutes after vaccination of the investigational drug (in case of the elderly over 75 years 
of age in Phase 2a, immediate adverse events are observed until at least 2 hours after 
vaccination of the investigational drug) 
7.1.2 Visit 2: Safety follow-up.  
Study procedures to be completed include:  
• 
Review and record concomitant medications 
• 
Perform targeted physical exam (relevant to participant system-specific complaints) 
• 
Perform and record vital signs 
• 
Review and record adverse events 

 
 
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• 
Review and record injection site reactions 
• 
Review of subject diary 
• 
Collect blood for hematology and chemistry  
7.1.3 Visit 3: Follow-up and booster vaccination 
Study procedures to be completed include:  
• 
Review and record concomitant medications 
• 
Perform targeted physical exam (relevant to participant system-specific complaints) 
• 
Perform and record vital signs 
• 
Review and record adverse events 
• 
Collect blood for hematology and chemistry  
• 
Collect blood for immunology testing (serum and PBMCs) 
• 
Collect urine for pregnancy testing (women of childbearing potential) 
• 
Administer study drug (GLS-5310 or placebo depending on randomization results) 
• 
Perform VAS score and record 
• 
Distribution of subject diary after vaccination 
• 
Check whether or not immediate adverse events (anaphylaxis-related) occur within 30 
minutes after vaccination of the investigational drug (in case of the elderly over 75 years 
of age in Phase 2a, immediate adverse events are observed until at least 2 hours after 
vaccination of the investigational drug) 
7.1.4 Telephone Visit 1: Safety follow-up.  
Study procedures to be completed include:  
• 
Review and record adverse events 
• 
Review and record injection site reactions 
 
7.1.5 
Visit 4: Post-vaccination follow-up, unblinding 
Study procedures to be completed include:  
• 
Review and record concomitant medications 
• 
Perform targeted physical exam (relevant to participant system-specific complaints) 
• 
Perform and record vital signs 
• 
Review and record adverse events 
• 
Review and record injection site reactions 
• 
Collect blood for hematology and chemistry  
• 
Collect blood for immunology testing (serum and PBMCs)  
• 
Inform participant of their treatment assignment 
o For those who received placebo, ask whether they would like to start vaccination 
series with GLS-5310(Refer to Section 7.2) 
 
7.1.6 Visits 5, 6, 7: Follow-up  
Study procedures to be completed include:  
• 
Review and record concomitant medications 
• 
Perform targeted physical exam (relevant to participant system-specific complaints) 
• 
Record vital signs 
• 
Review and record adverse events 
• 
Collect blood for immunology testing (serum and PBMCs) 

 
 
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7.1.10 Visit 8: End of Study or Early Termination (see above for Phase I) 
Study procedures to be completed include:  
• 
Review and record concomitant medications 
• 
Perform targeted physical exam (relevant to participant system-specific complaints) 
• 
Record vital signs 
• 
Review and record adverse events 
• 
Collect blood for hematology and chemistry  
• 
Collect blood for immunology testing (serum and PBMCs) 
7.1.11 Unscheduled visits 
Study procedures to be completed include:  
• 
Review and record concomitant medications 
• 
Perform targeted physical exam (relevant to participant system-specific complaints) 
• 
Perform and record vital signs 
• 
Review and record adverse events 
 
 
7.2 Procedures by Visit (GLS-5310 revaccination group, see clinical trial schedule 
S4) 
7.2.1 Visit 1: Vaccination 
• 
Review and record prior and concomitant medications  
• 
Perform and record physical examination and vital signs 
• 
Collect blood for hematology and chemistry safety labs (baseline values) 
• 
Collect blood for immunology testing (serum and PBMCs baseline values) 
• 
Collect urine for pregnancy testing (women of childbearing potential) 
• 
Administer study drug (GLS-5310) 
• 
Perform VAS score and record 
• 
Distribution of subject diary after vaccination 
• 
Check whether or not immediate adverse events (anaphylaxis-related) occur within 30 
minutes after vaccination of the investigational drug (in case of the elderly over 75 years 
of age in Phase 2a, immediate adverse events are observed until at least 2 hours after 
vaccination of the investigational drug) 
 
7.2.2 Visit 2: Safety follow-up.  
Study procedures to be completed include:  
• 
Review and record concomitant medications 
• 
Perform targeted physical exam (relevant to participant system-specific complaints) 
• 
Perform and record vital signs 
• 
Review and record adverse events 
• 
Review and record injection site reactions 
• 
Review of subject diary 
• 
Collect blood for hematology and chemistry  
 

 
 
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7.2.3 Visit 3: Follow-up and booster vaccination 
Study procedures to be completed include:  
• 
Review and record concomitant medications 
• 
Perform targeted physical exam (relevant to participant system-specific complaints) 
• 
Perform and record vital signs 
• 
Review and record adverse events 
• 
Collect blood for hematology and chemistry  
• 
Collect blood for immunology testing (serum and PBMCs) 
• 
Collect urine for pregnancy testing (women of childbearing potential) 
• 
Administer study drug (GLS-5310) 
• 
Perform VAS score and record 
• 
Distribution of subject diary after vaccination 
• 
Check whether or not immediate adverse events (anaphylaxis-related) occur within 30 
minutes after vaccination of the investigational drug (in case of the elderly over 75 years 
of age in Phase 2a, immediate adverse events are observed until at least 2 hours after 
vaccination of the investigational drug) 
 
7.2.4 Telephone Visit 1: Safety follow-up.  
Study procedures to be completed include:  
• 
Review and record adverse events 
• 
Review and record injection site reactions 
 
7.2.5 Visit 4: Post-vaccination follow-up 
Study procedures to be completed include:  
• 
Review and record concomitant medications 
• 
Perform targeted physical exam (relevant to participant system-specific complaints) 
• 
Perform and record vital signs 
• 
Review and record adverse events 
• 
Review and record injection site reactions 
• 
Collect blood for hematology and chemistry  
• 
Collect blood for immunology testing (serum and PBMCs)  
• 
Inform participant of their treatment assignment 
 
7.2.6 Visits 5, 6, 7: Follow-up  
Study procedures to be completed include:  
• 
Review and record concomitant medications 
• 
Perform targeted physical exam (relevant to participant system-specific complaints) 
• 
Record vital signs 
• 
Review and record adverse events 
• 
Collect blood for immunology testing (serum and PBMCs) 
 
7.2.10 Visit 8: End of Study or Early Termination  
Study procedures to be completed include:  
• 
Review and record concomitant medications 

 
 
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• 
Perform targeted physical exam (relevant to participant system-specific complaints) 
• 
Record vital signs 
• 
Review and record adverse events 
• 
Collect blood for hematology and chemistry  
• 
Collect blood for immunology testing (serum and PBMCs) 
 
7.2.11 Unscheduled visits 
Study procedures to be completed include:  
• 
Review and record concomitant medications 
• 
Perform targeted physical exam (relevant to participant system-specific complaints) 
• 
Perform and record vital signs 
• 
Review and record adverse events 
 
7.3 
Timing and Evaluations 
7.3.1 Informed Consent 
Study personnel will meet with prospective study participants, explain the study, and provide them 
with an informed consent form (ICF) that describes the screening tests, eligibility criteria for 
entering the study, study treatments and follow-up procedures. An informed consent must be 
signed prior to any study related procedures being performed. A copy of the signed and dated 
consent form will be given to the participant. 
7.3.2 Enrollment and Intake visit  
Participants who consent to be in the study will be assigned a unique PID#. Once assigned, PID#s 
cannot be reused for any reason. Information regarding participant’s PID# and screen date will 
also be documented on a screening log.  
Medical History 
Investigators should document all significant illnesses that the participant has experienced as 
Medical History within the past 24 weeks. Illnesses’ first occurring or detected during the study 
and/or worsening of an existing illness that occurs after the first administration of study drug are 
documented as AEs on the electronic case report form (eCRF).  
Prior / Concomitant medications 
Prior treatments for a period of 24 weeks prior to enrollment will be recorded. Concomitant 
treatments, defined as continuing or new treatments taken at or after the signing of the informed 
consent, will be recorded in the eCRF as concomitant medications. 
7.3.3 Adverse effects 
Adverse effects that will be queried at each study visit include those related to the underlying 
disease and treatment, those potentially related to study drug, and those potentially related to 
study drug administration. AEs should be graded according to the “Toxicity Grading Scale for 
Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials” issued 
in September 2007 by the US FDA (Appendix A). Subjects record the response (local and 
systemic) after vaccination on the evening of each vaccination day and 7 days after each 
vaccination day in the subject diary (Appendix B). 

 
 
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Subjects record the response to the injection site using the measurement tool provided, and the 
investigator reviews the subject diary. The response results described are evaluated for clinical 
significance and recorded as appropriate in the CRF. 
Subjects who develop Grade 1 or higher eosinophilia (eosinophil count of ≥ 650 cells/mm3) will 
be asked to return weekly for repeat CBC determinations until resolution of the eosinophilia. 
  
7.3.4  
Weight and Height 
Participant height and weight will be assessed and recorded at enrollment. BMI will be calculated 
automatically and recorded. 
7.3.5  
Chest X-ray test 
At the screening visit, a chest X-ray is performed on all subjects to determine suitability for the 
subject's safety. 
7.3.6  
12-Lead ECG 
An ECG will be performed at screening for all subjects to determine eligibility. The ECG should 
include measurements of ventricular rate, PR, QRS, QT, QTcF with assessment as to whether 
the ECG is normal or abnormal. Abnormal ECGs will 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, Medical Monitor or Sponsor 
consultant cardiologist and deemed safe to proceed. The ECG should be labeled as either 
“normal”, “not clinically significant”, avoiding abbreviations such as NCS, or “clinically significant, 
but stable to proceed” and kept with source documentation; alternatively case notes can reflect 
the ECG reading as source documentation. The method of QTcF determination should also be 
recorded and will be collected as part of the Case Report Forms. 
7.3.7 
 
PCR or Antibody test (SARS-CoV-2) 
At the screening visit, a point of care PCR or antibody test is performed on all subjects to 
determine serologic evidence of prior SARS-CoV-2 infection. 
7.4 
Assessment of injection site 
The injection site will be assessed by study personnel at each visit. Participants are to be 
instructed to monitor the site for signs of inflammation, redness, swelling, or pain and report these 
issues at the next study visit. Site staff will discuss any symptoms and determine whether these 
constitute AEs and record as appropriate. The subject should be instructed to record the exact 
symptoms, the diameter of the redness (cm), the diameter of the edema (cm), the diameter of the 
bruise (cm), and the date of onset and disappearance. 
7.5  
Immunogenicity assessments 
Blood to obtain serum and PBMCs for immunogenicity assessments will be collected at all visits, 
except for Visit 2 and unscheduled visits. Serum will be evaluated for antibody responses by 
ELISA against the SARS-CoV-2 S and ORF3a proteins. Serum will also be evaluated for 
neutralizing antibody responses. Induction of T cells will be determined by ELISPOT to determine 
interferon gamma (IFN-γ) responses of PBMCs against pools of 15-mer peptides spanning each 
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8  
Safety assessments 
8.1.1  Safety Parameters 
1) Adverse events 
2) Vital signs 
3) Laboratory evaluations 
4) Injection site reaction evaluations 
8.1.2  Safety Evaluations 
8.1.2.1  
Adverse Events (AEs) 
 
8.2.1.1  
Definition of Adverse Events 
An AE (also referred to as an adverse experience) is defined as any unfavorable and unintended 
sign, symptom or laboratory abnormality that is temporarily associated with the use of a drug or 
treatment and does not imply any judgement about causality. An adverse event can arise with 
any use of a drug or treatment regardless of route of administration, dose, and may be delayed 
after a drug or treatment has been discontinued. An adverse event is not the same as an 
“overdose”; an overdose is a dose-related event specifically caused by exposure to an increased 
amount of drug.  
 
Adverse drug reactions (ADRs) are all adverse and unintended reactions that occur at any dose 
of a study drug, and the causal relationship with the study drug cannot be denied. 
 
Adverse events of Special Interest (AESI) include enhanced disease of the immune system, and 
the following symptoms can be monitored more closely: 
 
• Patient with documented vital signs with: respiratory rate of ≥30 breaths per minute, heart rate 
≥ 125 per minute, SpO2 of ≤ 93% on room air, or PaO2/FiO2 of < 300 mm Hg. 
• Respiratory failure (requirement for high-flow oxygen, non-invasive ventilation, mechanical 
ventilation, or ECMO) 
• Shock (systolic BP of <9 0 mm Hg, or diastolic BP < 60 mm Hg, or need for vasopressors) 
• Significant acute renal failure, hepatic or neurologic dysfunction 
• Admission to ICU 
• Death 
 

 
 
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An unexpected AE is:  
• 
Not identified in the IB or otherwise not expected from the characteristics of the clinical 
material 
• 
Not listed at the specificity or severity that has been previously observed 
Treatment emergent AEs (TEAE) include the following: 
• 
Post-treatment complications that occur as a result of protocol mandated procedure  
• 
Any pre-existing condition that increases in severity, or changes in nature during or as a 
consequence of the study drug, will also be considered an AE 
• 
Complications and termination of pregnancy; see Section 7.1.8 for additional information.  
• 
  
 
Study related AEs do not include the following: 
• 
Elective medical or surgical procedures  
•     Non-elective medical or surgical procedures (Medical or surgical procedure (e.g. surgery, 
endoscopy, extraction, blood transfusion); On the other hand, the conditions that led to these 
procedures are considered adverse events.  
• 
Pre-existing diseases or conditions or laboratory abnormalities present or detected before 
study enrollment or prior to the first administration of study drug and dose not worsen  
•   Conditions where no undesirable medical event has occurred (e.g. hospitalization for planned 
surgery, hospitalization for social and/or accommodation)  
•   Incorrect or increased dose administration of study drug without adverse clinical sequelae  
•  Pre-existing diseases or conditions or laboratory abnormalities present or detected before study 
enrollment or prior to the first administration of study drug and dose not worsen. It is 
considered pre-existing and is recorded as a medical history in the eCRF.   
 
 • Any laboratory abnormality that is considered as non-significant   
• 
Uncomplicated pregnancy  
• 
An induced termination of pregnancy without medical reason  
8.1.2.1.2  
Serious Adverse Events (SAEs) 
 
A SAE is any AE that meets one of the following conditions 
• 
Death  
• 
Life-threatening event.  
• 
Event that requires inpatient admission to a hospital; (If hospitalization or extension of the 
existing hospital stay is required during the observation period defined in the clinical trial 
protocol (even if the hospitalization is made as a preventive measure for continuous 
observation, one night at the hospital regardless of the length of stay) This includes the case 
of doing things). 
Note: Observation, non-hospital evaluation, in a physician's office, hospital, or other emergency 
care setting, regardless of the duration of observation, is not a SAE;) 
• 
Results in congenital anomaly or birth defect; 
• 
Results in persistent or significant disability/incapacity; 
Is an important medical event that may not result in death or be life threatening, but based upon 
appropriate medical judgment, may jeopardize the participant and may require medical or 

 
 
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surgical intervention to prevent one of the outcomes listed above. Examples of such medical 
events include allergic bronchospasm and newly occurred convulsions. 
8.1.2.1.3  
Solicited local/systemic AE 
In the vaccination of this investigational drug, a feeling of pulling the skin may occur due to 
suction, and potential adverse events of the investigational drug may include erythema, pain, 
heat, or partial swelling at the injection site. Other adverse events that occur are included in the 
unexpected adverse events. 
The solicited local and systemic adverse events can be summarized as follows. 
Table 8.1.2.1.3-1 Solicited local/systemic AE 
Common 
• 
Mild to moderate administration site pain, erythema, 
tenderness, swelling, induration   
• 
Malaise/fatigue, myalgia, or headache in the first few days 
following injection 
• 
Visible lesion(s) at the injection site, such as erythematous 
papules with eschar, hypopigmentation, hyperpigmentation 
Less common 
• 
Administration site bruising/ecchymosis, hematoma or pruritus 
• 
Arthralgia or nausea 
• 
Injection site hematoma, bruising/ecchymosis, laceration, other 
transient lesions, or bleeding related to the injection procedure 
• 
Eosinophilia 
Uncommon or rare 
• 
Administration site, laceration, other transient lesions, or 
bleeding related to the injection procedure 
• 
Severe administration site pain or tenderness 
• 
Rash following injection/EP  
• 
Keloid scar or hypertrophic scar formation  
• 
Transient changes in clinical laboratory values 
Unknown frequency or 
theoretical potential 
risks 
• 
Severe localized administration site reaction, such as sterile 
abscess or secondary bacterial infection  
• 
Allergic reaction, including urticaria, angioedema, 
bronchospasm, or anaphylaxis  
• 
Chills, flu-like syndrome 
• 
Muscle damage at the administration site 
• 
Autoimmune disease 
• 
Effects on the fetus and on pregnancy 
 
8.1.2.1.4  
Unexpected Adverse Drug Reactions (ADRs) 
Unexpected ADR refers to an adverse drug reaction that differs in its pattern or severity of harm 
compared to the information of the investigational drug (refer to the investigator's data sheet). 
This includes delayed events such as anaphylaxis or allergic reactions related to vaccine 
administration, and unexplained neurological events. 

 
 
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8.1.2.1.5   Evaluation of adverse events 
All items identified for the adverse reaction, such as occurrence, symptom, date of onset, date 
of disappearance, severity, relationship with the investigational drug, related measures, 
treatment, and results, should be recorded in the e-CRF. 
Abnormal values of laboratory tests that are considered clinically significant, vital signs, and 
abnormal findings of ECG results are recorded as adverse reactions. 
8.1.2.1.6  
Assessing Severity (Intensity) 
The Investigator will grade laboratory AEs and clinical AEs (based on discussions with study 
participants) using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers 
Enrolled in Preventive Vaccine Clinical Trials (Appendix A): 
Adverse events will be recorded on the eCRF at the severity reported by the Investigator. 
• 
Mild (Grade 1)  
• 
Moderate (Grade 2)  
• 
Severe (Grade 3)  
• 
Potentially Life Threatening (Grade 4)  
 
8.1.2.1.7 
Causal Relationship of Clinical Material to Adverse Events 
A causally related AE is one judged to have a suspected relationship to the administration of the 
investigational agent. Conversely, an AE may also be assessed as not related to the 
investigational product. The Investigator is responsible for reporting adverse events and judging 
the relationship between the administration of the investigational product and an AE because the 
investigator is knowledgeable about the participant (e.g., medical history, concomitant 
medications), administers the investigational product, and monitors the participant’s response to 
the investigational product. The Sponsor will assess the overall safety of the investigational 
product and determine whether expedited reporting to regulatory agencies is indicated. 
Investigators should use their knowledge of the Study Participant, the circumstances surrounding 
the event, and an evaluation of any potential alternative causes to determine whether or not an 
adverse event is considered to be related to the study drug by the following criteria: 
• 
Related – the Investigator considers that there is a causal relationship between the event and 
study drug; 
• 
Probably related – the Investigator considers that there is a probability of a causal relationship 
of the event to the study drug 
• 
Possibly related – the Investigator considers that there is a possible causal relationship of the 
event to the study drug 
• 
Not related – the Investigator considers that the event has no relationship to administration of 
the study drug  
The following guidance should also be taken into consideration: 
• 
Temporal relationship of event to initiation of study drug; 
• 
Course of the event, discontinuation of study drug, or reintroduction of study drug (when 
applicable); 
• 
Known association of the event with the study drug or with similar treatments; 
• 
Known association of the event with the disease under study (as applicable); 

 
 
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• 
Presence of risk factors in the Study Participant or use of concomitant medications known to 
increase the occurrence of the event 
8.1.2.1.8 
Measures related to investigational products 
Any of the following measures with regard to investigational product dosing during the study if 
adverse events, abnormal laboratory values occur or in response to immunologic assessments: 
1)  Maintain the study drug dose  
2)  Increase the study drug dose  
3)  Decrease the study drug dose  
4)  Cessation of administration of study drug 
5)  Not applicable 
8.1.2.1.9 
Treatment for adverse Events 
Any of the following treatment measures that may be implemented during the study related to 
adverse events should be documented: 
1)  Treatment with medication therapies 
2)  Treatment with non-medication therapies 
3)  Treatment with both medication and non-medication therapies 
4)  No treatment 
8.1.2.1.10Consequences of adverse Events  
Any of the following consequences of abnormal events may occur and should be documented: 
 1)  Recovered 
 2)  Recovering 
 3)  Not Recovered 
 4)  Recovered, but after-effects remain 
 5)  Death 
 6)  Unknown 
 
8.1.3  
Physical Assessments and Targeted Physical Assessment 
A complete physical examination will be performed at study enrollment. Targeted physical 
examinations based on symptoms will be performed at subsequent visits based on participant 
complaints.  
8.1.4  
Vital Signs 
Participant vital signs will be performed and recorded at all study visits. 
8.1.5  
Safety Laboratory Evaluations 
Blood for a complete blood count with differential(RBC, hemoglobin, hematocrit, platelet, WBC, 
neutrophil, lymphocyte, monocyte, eosinophil, basophil) and chemistries (consisting of sodium, 
potassium, blood urea nitrogen (BUN), creatinine, glucose, ALT, and bilirubin, Ca, Cl, AST, ALP, 
CPK, albumin, total protein, total cholesterol) will be performed at Visits 1, 2, 4 and 8. A urine 
pregnancy test will be performed at Visit 1 and Visit 3 for those of childbearing potential. 
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events. According to the judgment of the investigator, a clinically significant abnormal value is 
reported as an adverse event, and if it is related to a clinical adverse event, it is reported as the 
name of the adverse event. For laboratory test results, normal/abnormal evaluation is performed 
according to the normal range of the clinical trial site, and the severity is evaluated by the Toxicity 
Grading Scale. 
8.1.6 Procedures for Documenting Pregnancy During Study 
Women of childbearing potential who are pregnant or expect to become pregnant within 4 weeks 
from the boost vaccination, or who cannot agree to use an approved form of birth control will be 
excluded from participation in the study. Approved forms of pregnancy prevention are as follows,  
① Hormonal contraceptives (e.g., oral progesterone single or estrogen-progesterone 
complex, transdermal delivery type contraceptives, depot injections, etc.) 
② Implantation of intrauterine devices or intrauterine systems 
③ Double blocking method [male physical blocking method (eg. male condom) and female 
physical blocking method (eg. cervix cap, contraceptive diaphragm, contraceptive sponge] 
are used in combination, and spermicide is used together. The use of condoms in all cases 
is not recommended as damage from physical friction may be less effective than expected 
contraception.) 
④ Surgery and operation status such as tubal ligation (resection), hysterectomy, and 
vasectomy (resection) 
Approved birth control methods include use of pills or injections of hormones to prevent 
pregnancy, use of a male or female condom with or without use of a spermicidal cream or gel, 
use of a diaphragm or cervical cap with concomitant use of a spermicidal cream or gel, IUD, or 
sexual abstinence. Should a participant become pregnant after enrolling in the study, she will not 
be given any further study treatment.  
Participants who become pregnant at any point during the study will continue to be followed for 
clinical safety assessments without receiving further investigational product. The Investigator will 
report any pregnancies to the study team and medical monitor (or designee), and to the 
Investigational Review Board (IRB). Sites should request the participant’s permission to follow the 
outcome of the pregnancy documenting such in the clinical study report. 
Subjects whose pregnancy is confirmed during the clinical trial period are followed up for safety 
evaluation with the vaccination of the investigational product discontinued. The decision regarding 
collection of safety and/or immunology labs will be deferred to the PI.  
If the participant does not wish to continue in the study and complete safety measurements, they 
will be listed as having withdrawn voluntarily.  
8.1.7 Post-study Reporting Requirements 
SAEs, including deaths, regardless of cause or relationship, must be reported to Sponsor at the 
time that such events become known to the Investigator. 
Investigators are not obligated to actively seek AEs or SAEs beyond the follow up period for 
participants. However, if the Investigator learns of an SAE that occurs within 30 days from 

 
 
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completion or termination visit, the Investigator should promptly document and report the event 
to the study team and medical monitor. 
8.2 
Methods and Timing for Collection and Recording of Safety Data 
At the time of each study visit, participants will be queried as to adverse events that have occurred 
in the interim period and the current status of any AE that was reported at a prior visit that has not 
yet resolved. Additionally, labs will be reviewed for safety.   
All AEs, regardless of severity, seriousness, or presumed relationship to study treatment, must 
be recorded using medical terminology in source documents and on the eCRF. Whenever 
possible, a diagnosis will be documented, in lieu of symptoms. The source document and the 
eCRF must contain the Investigator’s opinion concerning the relationship of the AE to study 
treatment. 
AEs should be described with the following attributes: 
• 
Duration (start and end dates) 
• 
Seriousness 
• 
Severity 
• 
Causality 
• 
Action(s) taken 
• 
Outcome 
8.3 
Safety and Toxicity Management 
The Medical Monitor will be responsible for the overall safety monitoring of the study. The site PI 
will be responsible locally for safety.  
Safety assessments include the following: 
• 
Incidence of all adverse events classified by system organ class (SOC), preferred term, 
severity, and relationship to study treatment 
• 
Changes in safety laboratory parameters  
• 
Other clinically significant changes in safety evaluations 
Local and systemic injection site review; special attention will be paid to the examination of the 
injection site. Administration site reactions and the participant's complaints will be documented. 
8.3.1 Events Requiring Expedited Reporting 
Events requiring expedited reporting (ERER) are defined as any Adverse Events including: 
• 
Grade 3 or greater systemic or local symptoms;  
• 
Grade 3 or greater laboratory abnormalities 
• 
Any episode of anaphylaxis or allergic reaction considered as study drug related or possibly 
study drug related 
Sites will inform the Sponsor of any ERER within 24 hours, or increase of severity of an adverse 
event to Grade 3, to discuss whether dosing to the participant should continue. 
8.3.2 Stopping Rules 
If any of the following situations occur, then further enrollment and Study Treatments will be halted 
immediately until a thorough investigation has been conducted by the Medical Monitor and PI and 
the IRB (if applicable): 

 
 
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• 
Any participant experiences a potentially life-threatening AE, Grade 4 AE or death assessed 
as related to Study Treatment; 
• 
Any report of anaphylaxis of Grade 3 or greater assessed as related to Study Treatment. 
Any SAE or death assessed as related to Study Treatment will lead to an immediate halt of study 
enrollment and Study Treatments, until the event has been investigated. 
8.3.3 Unblinding 
The Phase IIa portion of the study will be unblinded at study visit 4 and subjects informed of their 
treatment status. Subjects assigned to the placebo group may elect to receive vaccine. 
Regardless of later vaccination status, all subjects will remain in study for safety evaluations. 
In the Phase IIa study, all subjects, including those who were assigned to a placebo control group 
after unblinding, but subjects assigned to placebo who chose not to receive GLS-5310, will be 
followed for a year from study entry. 
Treatment assignments through to the post-vaccination visit (Visit #4) should be maintained as 
blinded unless unblinding is considered critical to the care and well-being of the subject and that 
knowledge of the treatment assignment will affect medical management and medical decision 
making. Unblinding prior to visit #4 should occur following discussion with Sponsor Medical 
Monitor. However, emergency unblinding can occur if the Investigator deems that such a delay 
would unduly harm the subject and that knowledge of the treatment assignment is a critical factor 
in medical decision making versus discontinuation or temporary discontinuation of a study drug 
until discussion with the Medical Monitor. In the case of unblinding, the Investigator is not required 
to inform the Sponsor of treatment assignment. Unblinded treatment assignment should be made 
known only to those who require such information as part of medical decision making and for 
those involved in Safety reporting to Health Authorities and/or or the relevant IRB or local 
oversight body. In addition, the immunogenicity assay staff must remain blinded until the assay is 
complete. 
Treatment assignments for immunologic measurement should be maintained as feasible 
throughout the study. 
The Investigational Pharmacy at each site will maintain a listing of treatment assignments and will 
provide a mechanism for unblinding in emergency situations.  
After unblinding, collect safety and efficacy results as much as possible even if you are not in the 
GLS-5310 vaccination group. 
 
 
 
9. 
EVALUATION OF IMMUNE RESPONSES 
9.1 Efficacy Parameters 
1) Determine of GMT and seroconversion rate of SARS-CoV-2 Spike and ORF3a 
protein specific binding antibody responses induced by GLS-5310 relative to 
treatment arm(Endpoint titer of binding antibody in serum at each timepoint) 

 
 
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2) Determine of GMT and positive responder rate of the neutralizing antibody response 
induced by GLS-5310(plaque-reduction neutralizing titer in serum at each timepoint) 
3) Determine the positive responder rate of T cell responses induced by GLS-
5310(Antigen-specific interferon gamma (IFN-γ) secretion T-cell response in PBMC 
at each timepoint) 
9.2  
Immunogenicity assessments 
9.2.1 SARS-CoV-2 Binding ELISA 
Standardized ELISA assays will be performed to measure the anti-SARS-CoV-2 S and ORF3a 
binding antibody responses. Samples will be scored as positive if the average optical density 
(OD) is greater than 0.10 absorbance units and greater than the average OD before 
immunization plus 2.5 times the standard deviation (SD) of the OD before immunization at the 
same dilution. Results will be presented as the geometric mean titer (GMT) of the antibody titer, 
end-point titer, i.e. the last dilution where the OD value is above the calculated threshold.  
The definition of seroconversion as a positive response post-baseline at the lowest dilution 
tested (i.e. and antibody titer that is below 1:100 at baseline and after vaccination positive at or 
above the 1:100 dilution) assuming that the baseline response would be negative at 1:100. The 
criteria for the appropriate immunogenicity of the SARS-CoV-2 binding antibody is planned to 
have a positive response rate of 70% or more in each group at the interim analysis. 
9.2.2 SARS-CoV-2 Serum Neutralization 
Neutralizing antibodies against SARS-CoV-2 will be performed the geometric mean of the 
antibody titer (Geometric mean titer, GMT) to determine the 50% neutralizing titer (NT50) using 
a plaque-reduction neutralizing titer (PRNT) by standard methodology with relevant virus strains 
and cell lines. Alternately, pseudovirion-based neutralization assays and/or SARS-CoV-2 
receptor binding inhibition assays may also be used to determine the breadth of the neutralizing 
antibody response to vaccination. The criteria for the appropriate immunogenicity of the SARS-
CoV-2 neutralizinig antibody is planned to have a positive response rate of 70% or more in each 
group at the interim analysis. 
9.2.3 SARS-CoV-2 ELISpot 
Cellular immune responses will be assessed by measuring the number of SARS-CoV-2 antigen-
specific IFN-γ secreting peripheral blood mononuclear cells (PBMCs) as determined by IFN-γ 
ELISpot assays. Cell responses to stimulation with SARS-CoV-2 peptides using 15-mer peptides 
overlapping by 10 amino acids spanning the entire S and ORF3a proteins will be measured and 
results reported as spot forming units per million cells (SFU/106 PBMC). Positive response cutoff 
calculations will include at least a fold-rise from subject-specific baseline SFU/106 PBMC values, 
based upon assay optimization criteria. The criteria for the appropriate immunogenicity of the 
SARS-CoV-2 T cell response is planned to have a positive response rate of 70% or more in each 
group at the interim analysis. 
10. 
EVALUATION OF EXPLORATORY ENDPOINTS 
10.1.1 Phase I Exploratory Endpoints  
1) Determine binding antibody responses after a single dose of vaccine related to treatment arm 
(Endpoint titer of binding antibody in serum at each timepoint)  
2) Determine whether passive transfer of human serum can protect against pulmonary infection 
from SARS-CoV-2 challenge in an animal infection model (Survival rate, blood and viral load 

 
 
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measurement of major organs, pathological examination of respiratory/lung area, immunogenicity 
evaluation) 
10.1.2 Phase IIa Exploratory Endpoints 
1) Determine the persistence of immune responses following vaccination with GLS-5310 (Endpoint titer of 
binding antibody in serum at each timepoint, Antigen-specific interferon gamma (IFN-γ) secretion 
T-cell response in PBMC at each timepoint, plaque-reduction neutralizing titer in serum at each 
timepoint) 
2) Determine the extent of immune boosting for participants who are seropositive at baseline following 
vaccination with GLS-5310 (Endpoint titer of binding antibody in serum at each timepoint, 
Antigen-specific interferon gamma (IFN-γ) secretion T-cell response in PBMC at each timepoint, 
plaque-reduction neutralizing titer in serum at each timepoint 
3) Determine the relative immune responses for those who are age 65 years and younger versus those 
who are age 66 to 85 years 
 
11. 
STATISTICAL METHODS and CONSIDERATIONS 
Prior to analysis a detailed Statistical Analysis Plan (SAP) will be written describing all analyses 
that will be performed. 
11.1 Data Sets to be Analyzed 
• 
The intention to treat population (ITT) includes all participants who sign informed consent.  
• 
The modified intention to treat population (mITT) includes all participants who sign informed 
consent and who has received at least one administration of study drug. The mITT population 
will be the primary analysis population for outcomes. 
• 
The safety set (SS) includes all participants who have received at least one dose of study 
medication. The SS will be the primary group for safety evaluations and outcome. Analysis of 
immune responses will be performed only for available samples.  
Per-protocol (PP) analysis set includes all participants who complete the trial and who receive all 
vaccinations and have no significant protocol violations. Participants in this sample will be 
grouped to treatment arms they actually received. This set will be used as a sensitivity analysis 
to summarize the primary and secondary efficacy outcomes. For secondary and exploratory 
assessments of antibody and T cell immune responses, denominators will include only those 
participants who are SARS-CoV-2 seronegative at baseline. Unevaluable samples will not be 
considered as part of the denominator at relevant time points. For study participants who are 
seropositive at baseline, separate assessment of antibody and T cell responses will be performed.  
The Phase IIa portion of the study will be unblinded at the post-vaccination visit (visit 4) and all 
persons who were randomized to the placebo arm offered vaccination with GLS-5310. Safety 
assessments will be determined based on the actual treatment received. Persons randomized to 
the placebo group who elect vaccination with GLS-5310 will then be considered to cross-over to 
the vaccination group as of Week 12. Persons randomized to the placebo group, and who decline 
vaccination will remain as part of the placebo group, regardless of whether such persons receive 
any other COVID-19 vaccine. Any study participant who receives an approved COVID-19 vaccine 
will remain as part of the group assignment as above.   

 
 
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11.2 Demographic and Other Baseline Characteristics 
Demographic and baseline data, vital signs, medical history, concomitant illnesses, and current 
medications/treatments, including surgeries will be summarized by means of descriptive statistics: 
continuous variables as mean, median, standard deviation, and categorical variables as 
frequencies and percentages. 
11.3 Safety Analysis 
All safety and tolerability summaries will be performed on the SS.  
11.3.1 Adverse events 
Treatment emergent AEs will be summarized by frequencies and will be presented by system 
organ class and preferred term with the number and percentage of participants affected. 
Frequencies will be presented with respect to maximum severity and to strongest relationship to 
Study Treatment. Multiple occurrences of the same AE will be counted only once following a 
worst-case approach with respect to severity and relationship to Study Treatment.  
Treatment emergent AEs will be summarized by estimates of proportions with exact 95% binomial 
CIs. The differences in proportion between the groups will also be calculated with 95% CIs. These 
frequencies will be summarized overall, by system organ class and by preferred term, for the 
number and percentage of participants affected. Additional frequencies will be presented with 
respect to maximum severity and to strongest relationship to Study Treatment. All serious AEs 
and administration site events will also be summarized as above.  
 
The main summary of safety data will be based on events occurring within 28 days of 
administration of Study Treatment at the time of interim analysis; long term safety will be assessed 
through to 48 weeks following the final vaccination for each group.  
 
VAS scores will be summarized with mean, median, minimum, and maximum values. 
 
11.3.2 Laboratory Data 
Continuous response variables per time point and changes from baseline will be summarized with 
mean, median, minimum, and maximum values. Categorical response variables will be 
summarized per time point with percentages.  
11.4 Immune Response Analysis 
The study is not designed or powered to determine efficacy of the vaccine. However, immune 
response to the vaccine may be assessed by responder analysis of the immunogenicity data.  
Immunogenicity results will be classified as responder/non-responder and will be analyzed as the 
frequency of responses for each assay for each treatment arm at each time point at which an 
assessment is performed. Estimates of proportions and exact 95% binomial CIs and 95% CIs for 
the differences between the groups will be calculated.  
Immunogenicity analysis will be performed in the mITT and PP groups with evaluable immune 
response data. 

 
 
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11.5 Interim Analysis 
An assessment of AE’s will be performed after study visit 1 for Group 1a. For the Phase I study, 
an interim analysis will be performed after study visit 4. In order to enter Phase IIa, the 
seroconversion rate for the binding antibody reaction between test groups is evaluated on the 
basis of >70%. In addition, the incidence of serious adverse events (Grade 3 or higher) related to 
the investigational drug is evaluated as 1 or less. For the Phase IIa study, an interim analysis will 
be performed after study visit 4.  
11.6 Sample Size and Randomization 
This clinical trial is a phase 1/2a clinical trial to evaluate the safety and immunogenicity of GLS-
5310 for the purpose of preventing COVID-19 set the required number of subjects.   
For the phase 1 study, 45 subjects who meet the inclusion and exclusion criteria will be enrolled 
in order to secure 15 subjects to be vaccinated for investigational drugs for each vaccination group. 
For the phase 2a study, it was planned to secure 120 subjects based on randomization. 
Randomization was performed 1:1 in groups 1b and 1c of the phase 1 study according to the pre-
planned randomization generation number, and 2a, 2b in the phase 2a study to determine the 
difference between placebo and vaccine randomization is performed 1:2 in groups. 
11.7 Missing Values 
In the event that dates and/or times are missing for medications, medications will be assumed to 
be concomitant. In the event dates or times are missing for AEs, AEs will assume to be treatment 
emergent. Missing outcomes values, such as missed lab draws or invalid blood sample, missed 
vital signs, or missed or uninterpretable serum concentrations and PBMCs will be left as missing 
and not imputed. For the immunology analyses, statistical assessment will be based on available 
results.  
In the event that a participant is enrolled in the trial but declines to be vaccinated then the site will 
enroll a replacement.   
11.8 
Unblinding 
For safety analysis the study will be unblinded after database lock for analysis.  Since subjects who were 
randomized to placebo will have the opportunity to be given the vaccine, safety assessments can be 
divided into 3 groups: 
1) Randomized to vaccine 
2) Randomized to placebo 
3) Subset of Placebo subjects who received vaccine after unblinding 
In addition, among the subjects assigned to the GLS-5310 vaccination group and the placebo group, the 
GLS-5310vaccinated group and the revaccinated group are analyzed separately. 
12. 
DATA COLLECTION, MONITORING AND AE REPORTING 
12.1 Confidentiality 
Information about study participants will be kept confidential to the best of the study site’s ability. 
If a study participant cancels consent to the collection or use of personal health information (PHI), 
the sponsor may continue to use the information collected prior to the cancellation of the informed 
consent. For subjects who revoke consent to collection or use of PHI, consent should be obtained 

 
 
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for collection of critical conditions (i.e., survival of study participant), at least before completion of 
their planned clinical trial period. 
12.2 Source Documents 
Source data is all information, original records or clinical findings, observations, or other activities 
in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are 
contained in original source documents. Examples of these original documents and data records 
include (as applicable): hospital records, clinical and office charts, laboratory notes, memoranda, 
participant’s diaries or evaluation checklists, pharmacy dispensing records, recorded data from 
automated instruments, copies or transcriptions certified after verification as being accurate and 
complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, participant 
files, pharmacy records, laboratory records, medical records (including electronic records) relative 
to the clinical trial. For this study, documents relevant to documenting and verifying inclusion and 
exclusion criteria, prior medical history, concomitant medications, safety labs, and assessments 
relevant to any AE’s are pertinent.   
12.3 Data Collection 
Data will be collected using Electronic Data Capture (EDC). Participants will be identified by PID#; 
no participant personal information (PPI) is collected as part of the EDC; nor is PPI retained as 
part of study data. All PPI is retained at each site and controlled by the site PI.  
12.4 Record Retention 
It is the Investigator’s responsibility to retain study essential documents as per country regulations: 
in the US for at least 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 2 
years have elapsed since the formal discontinuation of clinical development of the investigational 
product. The sponsor will inform the investigator/institution as to when these documents are no 
longer needed to be retained. 
12.5 Safety and Quality Monitoring and Record Availability 
Monitoring of the clinical trial will be performed by experienced monitors, who will report to the 
Sponsor as outlined in the Monitoring Plan. 
The investigator will make study documents (e.g., ICFs, drug accountability forms) and pertinent 
hospital or clinic records readily available for inspection by the local IRB, the site monitors, 
regulatory agencies, GeneOne Life Science, Inc. or its designee for confirmation of the study data. 
Participation as an Investigator in this study implies acceptance of potential inspection by 
regulatory authorities and applicable compliance and quality assurance offices. 
12.6 Adverse event (AE) Reporting 
AEs will be recorded and forwarded to regulatory agencies as required (e.g. Annual report). 
12.6.1 Study Reporting Period of Adverse Events 
All solicited and unsolicited adverse events are collected during the entire study period and 
recorded in the eCRF. 
12.6.2 Study Reporting Period for Serious Adverse Events  
SAE’s will be recorded throughout the study and the 28-day follow-up period. 

 
 
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Expedited reporting of SAEs will be determined by GeneOne Life Science using reference safety 
information specified in the Investigator’s Brochure. An event may qualify for expedited reporting 
to regulatory authorities if it is an SAE, SUSAR in line with relevant regulatory requirements.  
At any time after completion of the SAE reporting period, if an Investigator becomes aware of an 
SAE that is suspected by the Investigator to be related to the study drug, the event will be reported 
to the Sponsor. 
SAE TELEPHONE AND CONTACT INFORMATION: 
SAE REPORTING 
 
MEDICAL MONITOR: 
C&R Research 
 
Joel Maslow, MD PhD MBA 
 
 
MAILING ADDRESS: 
PHONE: 
(484) 965-9147p; (610) 331-7844 c 
 
GeneOne Life Science, Inc. 
MEDICAL LIAISON: 
Hyojin Lee, M. Sc. 
 
Parc.1 NH Finance Tower (Tower 2) 
20th 
floor, 
108 
Yeoui-Daero, 
Yeongdeungpo-Gu, 
CELL: 
02-3458-4058 
 
 
EMAIL: 
hjlee@genels.com 
 
Seoul 07335 Korea 
GeneOne FACSIMILE: 
02-3458-4042 
 
 
GeneOne Safety Email 
hjlee@genels.com 
 
 
 
The report should contain as much clinical safety information as possible, but at minimum, the 
initial report must include the following information: 
• 
Participant number and Study name 
• 
Date of Onset and Date of Resolution (if applicable) 
• 
Detailed description of event 
• 
Investigational product (if known) 
• 
Causal relationship of event to investigational product 
• 
Reporter name and contact information 
Follow-up reports will be sent as soon as more information becomes available. Events for which 
the study participant seeks medical care, the study site will attempt to obtain relevant medical 
records to include as source documents. These include but are not limited to discharge summary, 
results of relevant laboratory tests, and reports of relevant radiographic studies. In the case of 
death, the investigator will attempt to procure relevant reports (such as autopsy reports, medical 
examiner report, discharge summary).  
Each SAE must be followed by the Investigator until resolution, stabilization, or return to baseline, 
even if this extends beyond the end of the study, with follow-up report filed to provide a summary 
of the event through resolution.  
• The original SAE form must be kept at the study site. Copies (or electronic copy) 
will be provided to GeneOne Life Science or its representative, who will be 
responsible for reporting to regulatory authorities as indicated, and copy will be 
forwarded to the study sites IRB.  
12.6.3 Notification of Serious Adverse Events 
In accordance with local regulations, the Sponsor shall notify the appropriate regulatory 
authorities, and all participating investigators in a written safety report of any adverse experience 
associated with the use of the product that is both serious and unexpected. Reports of SUSARs 

 
 
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shall be made as soon as possible and in no event later than 15 calendar days after the Sponsor’s 
initial receipt of the information. Written notification may be submitted on the form described above 
or equivalent or in a narrative format and shall bear prominent identification of its contents. Each 
written notification to regulatory agencies shall be transmitted to the division that has responsibility 
for review. In each written safety report, the Sponsor shall identify all safety reports previously 
filed concerning a similar adverse experience and shall analyze the significance of the adverse 
experience in light of the previous, similar reports. The Sponsor shall also notify the relevant 
regulatory authorities by telephone or by facsimile transmission of all deaths regardless of 
causality and any unexpected fatal or life-threatening experience associated with the use of the 
drug as soon as possible but in no event later than 7 calendar days after the Sponsor’s initial 
receipt of the information. Each telephone call or facsimile transmission to regulatory agencies 
shall be transmitted to the division that has responsibility for review.  
Follow up information to a safety report shall be submitted as soon as the relevant information is 
available. If the results of a Sponsor’s event investigation show that an adverse drug experience 
not initially determined to be reportable is, in fact, reportable, the Sponsor shall report such 
experience in a written safety report as soon as possible, but in no event later than 15 calendar 
days after the determination is made. Results of investigations of other safety information shall 
be submitted, as appropriate, in an information amendment or annual report. In the event of death, 
if an autopsy is performed, a copy of the report, redacted for PHI but labeled with the PID#, should 
be sent to GeneOne Life Science, Inc. 
The MFDS may request the sponsor to submit the sponsor's monitoring report to the laboratory 
for the first case reported as "SUSAR causing death". 
Through this, a survey can be conducted when necessary, such as finding that the investigator 
does not comply with major clinical trial standards. 
12.7 Study Discontinuation 
GeneOne Life Science reserves the right to discontinue the study for safety or administrative 
reasons, including lack of enrollment, at any time. Investigational product must be returned to 
GeneOne, unless instructed otherwise. Document retention will follow local regulation.   
 
13. 
ETHICAL CONSIDERATIONS AND ADMINISTRATIVE 
PROCEDURES 
13.1 Clinical trial management standards and Declaration of Helsinki  
The procedures specified in this protocol are the international council for harmonization of 
technical requirements for pharmaceuticals for human use-good clinical practice (ICH-GCP), 
Korean good clinical practice (KGCP) and Declaration of Helsinki. 
This clinical trial will be conducted in accordance with the ethics regulations based on the 
Declaration of Helsinki, ICH-GCP, KGCP and related laws. 

 
 
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13.2 
Consent of Study Participant 
1) The investigator must give the study participant (the study participant's representative, if 
applicable) a sufficient opportunity to explain in detail all matters related to the clinical trial and to 
know all predictable results. 
2) If consent cannot be obtained due to reasons such as lack of comprehension ability or intention 
expression ability of the study participant, the written consent of the representative is obtained. In 
this case, the consent of the representative shall not contradict the intention of the study 
participant. The representative of the study participant shall be the legal representative, in the 
order of spouse, direct continuation, and direct subordinate if there is no legal representative, but 
if there are several direct or direct descendants, it is determined by consultation. 
3) The investigator must provide sufficient time for the study participant (representative, if 
necessary) to voluntarily decide on participation. Therefore, upon completion of the explanation, 
the subject (representative, if necessary) can decide whether to participate in the clinical trial in 
an independent space where the investigator and the investigator are not present (meaning to 
take time to consider it sufficiently), and the next possible visit It is recommended to be able to 
make decisions in the city. 
4) The contents agreed by the study participant (representative if necessary) must be recorded in 
documents. 
5) The investigator must confirm the participation of the study participant (representative, if 
necessary) in the clinical trial by signing the Informed Consent Form (Attachment 1)'. Investigators 
should not perform specific tests for the sole purpose of clinical trials until consent is obtained 
from the study participant (if necessary, an agent). 
6) The investigator must confirm whether the study participant (representative if necessary) 
continues to participate in the clinical trial at each visit after obtaining written consent. 
7) The investigator should emphasize that the subject (representative, if necessary) has the 
freedom to withdraw his/her consent to participation at any time without disadvantage or loss of 
the original interest. 
8) When new information is identified that may relate to the study participant (representative, if 
necessary) willingness to continue participating in the clinical trial, the investigator shall inform 
the study participant (representative, if necessary) of this information in a timely manner.  
13.3 Compliance with Ethics 
Clinical trials should be conducted in accordance with the clinical trial protocol (including the 
subject's description and consent form) approved by the Institutional Review Committee and 
MFDS. Clinical trials should be performed in accordance with the items described in Section 11.1. 
13.4 Study Participant Safety Protection Measures 
Based on the Declaration of Helsinki, the investigator must carry out the clinical trial according to 
Section 11.1 with the rights and welfare of the subject in mind, and all investigators and 
investigators must accurately understand the clinical trial protocol and perform the clinical trial in 
compliance with the protocol do. 

 
 
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The Investigators must take precautions such as sufficient education for the clinical trials 
personnel, and promptly respond to the occurrence of adverse reactions and perform necessary 
reports. 
13.5 Publication of Research Findings 
Publication of the results of this trial will be allowed. Any proposed presentation, abstract and/or 
manuscript must be made available to GeneOne at least 60 days prior to submission. GeneOne 
shall have fifteen (15) days for review. If GeneOne considers that material would reveal 
protectable intellectual property, GeneOne may request a delay in submission for a maximum of 
three (3) months from the date of receipt in order for patent application(s) to be filed with the 
United States Patent and Trademark Office and/or foreign patent office(s). 
13.6 Quality Control and Reliability Assurance 
Sponsors are responsible for verifying procedures and data for conducting clinical trials to protect 
subjects and ensure the reliability of clinical trial results. 
The sponsor conducts an advance visit prior to the initiation of the clinical trial, and recruits 
subjects after the initiation visit. In order to ensure that clinical trials are performed in compliance 
with the matters described in Section 11.1, and clinical trial results can be recognized at the time 
of registration at home and abroad, the sponsor of the clinical trial may conduct monitoring and 
audit. The test manager agreed to conduct the inspection by signing this protocol. 
At the monitoring visit, the sponsor will check against the supporting documentation to ensure 
that the clinical trial is being carried out in accordance with the approved protocol and items 
described in Section 11.1, and that the eCRF records are complete and clear. The investigator 
and the head of the clinical trial site (if applicable) must agree to and cooperate with the sponsor 
to directly access all relevant data and to devote time to the investigator oneself or the person 
concerned to discuss the problems found and related matters. . 
The reguratory authority may also conduct an investigation at any time during the clinical trial or 
at the end of the clinical trial. In the case of inspection or investigation, the investigator (and the 
clinical trial site) allows the inspector and the investigator to directly access the relevant 
documents, and devotes the investigator himself or the person concerned to discuss the found 
problems and related matters and must agree and cooperate with what to do. 
13.6 Approval of Clinical Trial Protocol 
The clinical trials can be started after the clinical trial protocol and related documents are 
submitted to the MFDS and the Institutional Review Committee and approved. 
13.6 Changes in Clinical Trial Protocol 
Neither the investigator nor the sponsor may change the contents of this clinical trial protocol 
during the clinical trial without the consent of the other party. Once the test has begun, 
modifications should be made only in exceptional cases. Any changes to the clinical trial protocol 
must be signed and agreed in writing by all parties involved. Before conducting a clinical trial with 
the changed contents, the modified clinical trial protocol must be submitted to the MFDS and/or 
the Institutional Review Committee for approval. 

 
 
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13.6 Data and Safety Monitoring Board (DSMB) 
In this clinical trial, an independent data and safety monitoring board (DSMB) is convened to 
evaluate the safety of subjects. The DSMB is convened at the request of investigators and 
sponsors, and carefully reviews safety data and immunogenicity data to evaluate the entry into 
phase 2. 
The DSMB consists of the sponsor, the investigator of the laboratory, or its delegated person, and 
may include a clinical pharmacologist if necessary. Matters concerning the operation of the DSMB 
follow a separate plan. 
 
14. 
INFORMATION OF THE PERSON WHO INTENDS TO CONDUCT 
THE CLINICAL TRIAL 
14.1 Sponsor 
GeneOne Life Science, Inc. 
President & CEO: Young K. Park 
Parc. 1 NH Finance Tower (Tower 2), 20th Floor 
108 Yeoui-Daero  
Yeongdeungpo-Gu, Seoul 07355, Korea 
14.2 Principal Investigator 
Role 
Clinical Site 
Position 
Name 
Principal Investigator 
(Cordinator) 
TBD 
TBD 
TBD 
Principal Investigator 
TBD 
TBD 
TBD 
 
14.3 Contract Research Organization 
C&R Research 
President & CEO: Moon Tae Yoon 
06199, 412, Yeoksam-ro, Gangnam-gu, Seoul, Korea 
 
15. 
OTHER 
MATTERS 
NECESSARY 
TO 
SAFELY 
AND 
SCIENTIFICALLY CONDUCT CLINICAL TRIALS 
15.1 Clinical Trials Site 
The head of a clinical trial site should equip the necessary facilities, professional manpower, and 
independent ethical institution for the execution of the relevant clinical trial at each stage of the 

 
 
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clinical trial, and make perfect preparations so that the relevant clinical trial can be properly carried 
out. 
15.2 Principal Investigator and Clinical Site Staffs 
The principal investigator and clinical site staffs should be fully aware of predicted adverse events 
and precautions for use through available information related to clinical investigational drugs, such 
as IB or drug attachments provided through the sponsor, and SAEs occurred during the clinical 
trial. In this case, the report shall be immediately reported to the Institutional Review Committee 
and the sponsor. 
15.3 Protocol Violation 
If it is known that the clinical trial protocol has been violated during the clinical trial, the investigator 
should notify the sponsor (or monitor) of the violation as soon as possible, and discuss and decide 
whether the subject continues to participate in the clinical trial. 
In the case of dropout due to a serious clinical trial protocol violation (Section 4.4), all information 
collected up to the point of dropout and reasons for dropout should be collected in the eCRF. 
15.4 Criteria for Treatment of Subjects after Clinical Trials 
Treatment after the clinical trial for the subjects who dropped out of the clinical trial (Section 4.4) 
and those who completed the clinical trial should follow the general criteria for treatment and 
treatment. 
However, if the subject is injured due to treatment or clinical procedures that would not have been 
received if they did not participate in this clinical trial, all treatments will be received according to 
the standard hospital procedures. Damage related to clinical trials will be borne by the sponsor in 
accordance with the sponsor's clinical trial victim compensation protocol and the terms and 
conditions of the sponsor's clinical trial compensation insurance. 
 
16. 
REFERENCES 
1. 
COVID-19 vaccine tracker and landscape; 2021. 
2. 
van Doremalen N, Lambe L, Spencer A, et al. ChAdOx1 nCoV-19 vaccination prevents 
SARS-CoV-2 
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in 
rhesus 
macaques. 
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3. 
Smith TRF, Patel A, Ramos S, et al. Immunogenicity of a DNA vaccine candidate for 
COVID-19. Nat Commun 2020 11(1):2601. 
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Gao Q, Bao L, Mao H, et al. Development of an inactivated vaccine candidate for SARS-
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5. 
Modjarrad K, Roberts CC, Mills KT, et al. Safety and immunogenicity of an anti-Middle 
East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-
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6. 
Roberts CC, Oh MD, Kim ES, et al. Phase I-IIa study of GLS-5300 vaccine against the 
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immune responses are elicited in lower-dose 2 and 3 vaccination intradermally administered 
regimens.  ASGCT; 2020 13-15 May, 2020; Boston, MA. 
7. 
Yu J, Tostanoski LH, Peter L, et al. DNA vaccine protection against SARS-CoV-2 in rhesus 
macaques. Science 2020 May 20:eabc6284. 
8. 
Deming D, Sheahan T, Heise M, et al. Vaccine efficacy in senescent mice challenged with 
recombinant SARS-CoV bearing epidemic and zoonotic spike variants. PLoS Med 2006 
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9. 
Yasui F, Kai C, Kitabatake M, et al. Prior immunization with severe acute respiratory 
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Hotez PJ, Bottazzi ME, Corry DB. The potential role of Th17 immune responses in 
coronavirus immunopathology and vaccine-induced immune enhancemen. Microbes Infect 2020 
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11. 
Lambert PH, Ambrosino DM, Andersen SR, et al. Consensus summary report for CEPI/BC 
March 12-13, 2020 meeting: Assessment of risk of disease enhancement with COVID-19 
vaccines. Vaccine 2020 38:4783-91. 
12. 
Ho MS, Chen WJ, Chen HY, et al. Neutralizing antibody response and SARS severity. 
Emerg Infect Dis 2005 11:1730-7. 
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Li CK, Wu H, Yan H, et al. T cell responses to whole SARS coronavirus in humans. J 
Immunol 2008 181:5490-500. 
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Lu B, Tao L, Wang T, et al. Humoral and cellular immune responses induced by 3a DNA 
vaccines against severe acute respiratory syndrome (SARS) or SARS-like coronavirus in mice. 
Clin Vaccine Immunol 2009 16:73-7. 
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Grifoni A, Weiskopf D, Ramirez SI, et al. Targets of T cell responses to SARS-CoV-2 
coronavirus in humans with COVID-19 disease and unexposed individuals. Cell 2020 181:1489-
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