A Phase I/II, First-in-human, Observer-blinded, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of TAP-COVID-19 SARS-CoV-2 Vaccine With CpG Adjuvant in Healthy Adults Aged 18-49 and 50-85
Phase: PHASE1
Conditions: Covid19
Sponsor: KBio Inc

CONFIDENTIAL 
12 November 2021 
Page 1 
 
 
Clinical Study Protocol 
 
 
A Phase I/II, First-in-human, Observer-blinded, Randomized, Placebo-controlled, Parallel Group 
Study to Evaluate the Safety and Immunogenicity of TAP-COVID-19 SARS-CoV-2 Vaccine 
with CpG Adjuvant in Healthy Adults Aged 18-49 and 50-85 
 
Protocol Number: KBP-201 
 
 
Version 9.0  
Date: 12 November 2021 
 
Sponsor: 
Kentucky BioProcessing, Inc. 
3700 Airpark Drive 
Owensboro, KY 42301 USA 
Telephone: 270-689-2570 
Contract Research 
Organization: 
ICON Clinical Research, LLC 
820 West Diamond Avenue, Suite 100 
Gaithersburg, MD 20878 USA 
Telephone: 301-944-6800 
Fax: 215-699-6288 
 
 
 
Confidentiality Statement 
This document and the information contained herein or attached hereto ("Confidential Material") are confidential 
and proprietary to Kentucky BioProcessing, Inc. This Confidential Material should be viewed only by those 
individuals or companies that have been given prior authorization to do so by Kentucky BioProcessing, Inc. 
("Authorized Users"). This Confidential Material should not be made available in any form to any person or 
company, other than the Authorized Users and their respective employees or associates on a need-to-know basis, 
without the prior written consent from Kentucky BioProcessing, Inc.

Kentucky BioProcessing, Inc. 
Protocol Number: KBP-201 
Protocol Version 9.0 
 
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1 
SYNOPSIS 
Protocol Title: 
A Phase I/II, First-in-human, Observer-blinded, Randomized, Placebo-controlled, Parallel 
Group Study to Evaluate the Safety and Immunogenicity of TAP-COVID-19 SARS-CoV-2 
Vaccine with CpG Adjuvant in Healthy Adults Aged 18-49 and 50-85 
Study Phase: 
Phase I/II 
Objectives: 
Primary Objective: 
• 
To assess the safety and reactogenicity of two doses of TAP-COVID-19 vaccine with 
Cytosine PhosphoGuanine (CpG) adjuvant for 7 days post vaccination compared with 
placebo as determined by solicited local and systemic reactogenicity 
Secondary Objectives: 
• 
To compare the frequency of unsolicited adverse events (AEs) of each dose of 
TAP-COVID-19 vaccine with CpG adjuvant through Day 43 and serious adverse 
events (SAEs), medically attended adverse events (MAAEs), new onset chronic 
diseases (NOCDs), and adverse events of special interest (AESIs) through Day 365  
Comparisons include: 
o 
High dose (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG) to placebo 
o 
Low dose (15 μg TAP-COVID-19 vaccine + 0.5 mg CpG) to placebo 
o 
High dose (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG) to low dose 
(15 μg TAP-COVID-19 vaccine + 0.5 mg CpG) 
• 
To evaluate the immunogenicity of TAP-COVID-19 vaccine with CpG adjuvant 
compared with placebo in terms of antibody assessed by geometric mean titers (GMTs) 
of both spike receptor binding domain (RBD) IgG and IgM antibodies and neutralizing 
antibody response, geometric mean fold rise (GMFR) in neutralizing titer from baseline 
in all treatment groups at Days 8, 22, 29, 43, 90, 181, 273, and 365 relative to baseline 
Exploratory Objectives: 
• 
To assess cellular immunity by measuring the numbers of cytokine producing CD4+ 
and CD8+ T-cells from peripheral blood mononuclear cells (PBMCs) response to 
vaccine in all treatment groups at Days 8, 22, 29, 43, 90, 181, 273, and 365 compared 
to baseline  
• 
To assess the immunogenicity of the RBD and Fc component of the vaccine 
Endpoints: 
Primary Endpoints: 
Occurrence of Solicited AEs: 
• 
Solicited administration site reactions (eg, pain, tenderness, erythema/redness, 
induration/swelling) during the 7-day follow-up period after each vaccination (Day 1-8 
and Day 22-29) 
• 
Solicited systemic events (eg, fever, nausea/vomiting, diarrhea, headache, fatigue, 
myalgia) during the 7-day follow-up period after each vaccination (Day 1-8 and 
Day 22-29) 
Secondary Endpoints: 
Safety: 
• 
Unsolicited AEs, MAAEs, and AESIs up to Day 43  
• 
SAEs, MAAEs, NOCDs, and AESIs up to Day 365 (approximately 1 year after first 
vaccination) 
Immunogenicity: 
Vaccine enzyme-linked immunosorbent assay of both spike receptor binding domain (RBD) 
IgG and IgM antibodies and neutralizing antibody titers for each treatment group: 
• 
GMT at baseline and Days 15, 22, 43, 90, 181, 273, and 365 
• 
GMT ratio (GMTplacebo/GMTTAP-COVID-19) at baseline and Days 22, 29, 43, 90, 181, 273, 

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and 365 
• 
GMFR at Days 8, 22, 29, 43, 90, 181, 273, and 365 relative to baseline 
• 
Seroconversion rates on Days 8, 15, 22, 29, 43, 90, 181, 273, and 365. Seroconversion 
is defined as the proportion of subjects at the respective time point that have detectable 
antibodies (IgG and IgM) against SARS-CoV-2 Spike Protein RBD following 
challenge with vaccine (and potentially by natural asymptomatic or symptomatic 
infection by the virus in case of a placebo subject). 
• 
Geometric mean increase (GMI) on Days 8, 22, 29, 43, 90, 181, 273, and 365 
Exploratory Endpoints: 
Cellular immunity: 
• 
The number of cytokine producing CD4+ and CD8+ T-cells from PBMCs responsive 
to vaccine antigens in all treatment groups on Days 8, 22, 29, 43, 90, 181, 273, and 365 
compared to baseline  
Immunogenicity: 
• 
Anti-RBD and anti-Fc antibodies at baseline and Days 8, 15, 22, 29, 43, 90, 181, 273, 
and 365 
Study Design: 
This is a first-in-human (FIH), observer-blinded, randomized, placebo-controlled, parallel 
group study to evaluate the safety and immunogenicity of TAP-COVID-19 vaccine with 
CpG adjuvant in healthy adult subjects in 2 age groups, Part A (18-49 years) and Part B 
(50-85 years). A study schematic is presented in Figure 4-1. 
PART A and PART B: 
Subjects will be screened up to 14 days (Day -14 to Day -1) before randomization. Overall, 
approximately 90 eligible healthy adults ages 18-49 years (inclusive) will be enrolled for 
Part A and 90 eligible healthy adults ages 50-85 years will be enrolled for Part B.  
Sentinel dosing will be utilized in this FIH study. Sentinel cohorts will be used for the 
following groups:  
⁃ 
Part A (18-49 years) low dose (15 μg TAP-COVID-19 vaccine + 0.5 mg CpG)  
⁃ 
Part B (50-85 years) low dose (15 μg TAP-COVID-19 vaccine + 0.5 mg CpG)  
⁃ 
Part A (18-49 years) high dose (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG)  
⁃ 
Part B (50-85 years) high dose (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG)  
Three sentinel subjects from each part will be randomized 2:1 (active:placebo). The 
independent Safety Review Committee (iSRC) will review the safety and tolerability data 
for the sentinel subjects through Day 8 prior to enrollment of the remaining cohort subjects 
randomized 2:1 (active:placebo).  
When all subjects in Part A (18-49 years) low dose have received the first vaccination and 
have all safety data through Day 8, the iSRC will convene and review the safety data to 
ensure that there are no safety concerns and that none of the Study Halting Rules have been 
met before recommending that the study enroll Part A high dose and Part B (50-85 years) 
low dose.  
When all subjects in Part B (50-85 years) low dose have received the first vaccination and 
have all safety data through Day 8, the iSRC will convene and review the safety data to 
ensure that there are no safety concerns and that none of the Study Halting Rules have been 
met before recommending that the study enroll Part B high dose. 
The iSRC will convene and review the safety data when a minimum of 23 subjects have 
completed Day 29 after the second vaccination for Part A (low and high dose) and for Part B 
(low and high dose) to ensure that there are no concerns. 
Both Part A (18-49 years) and Part B (50-85 years) will be randomized in a 2:1 ratio 
(active:placebo) for each treatment dose (15 μg and 45 μg TAP-COVID-19 vaccine + 0.5 mg 
CpG) for a total of 90 subjects per Part (30 subjects 15 μg TAP-COVID-19 vaccine + 0.5 mg 
CpG:30 subjects 45 μg TAP-COVID-19 vaccine + 0.5 mg CpG:30 subjects placebo). 
Treatment A: TAP-COVID-19 vaccine (15 μg) + CpG (0.5 mg) intramuscular (IM) injection 

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on Day 1 and Day 22 (±3 days) 
Treatment B: TAP-COVID-19 vaccine (45 μg) + CpG (0.5 mg) IM injection on 
Day 1 and Day 22 (±3 days) 
Treatment C: Placebo (buffered saline solution) IM injection on Day 1 and Day 2 
(±3 days) 
Study vaccine will be prepared by an unblinded site pharmacist and administered at the 
clinical research site on Day 1 and Day 22 (±3 days) by unblinded clinical research unit 
(CRU) personnel. Subjects will be observed for immediate AEs and/or reactogenicity for 
approximately 60 minutes after administration of vaccine. Subjects will be provided with a 
Diary Card and will be trained to record specifically elicited systemic and local symptoms 
daily as well as any additional AEs during the 7-day follow-up period after each vaccination. 
Visits will be conducted at the clinical site on an outpatient basis or as a telephone visit per 
the Schedule of Assessments and Procedures. Subjects will participate in the study for 
approximately 1 year from the first dose. 
AEs and concomitant medications will be captured through Day 43. Blood and serum 
samples for safety laboratory tests, RBD IgG and IgM antibodies and neutralizing antibody 
titers, cell-mediated immunity, and other future biomedical research will be obtained at 
baseline and before administration of vaccine dose 2 and after each vaccination per the 
Schedule of Assessments and Procedures. SAEs, MAAEs, NOCDs, and AESIs only will be 
captured after Day 43 to study completion (Day 365 [approximately 1 year after first 
vaccination]).  
Prior to receiving a second dose of vaccine, subjects will have the following assessments 
performed to ensure eligibility: vital signs (including temperature), review of clinical 
laboratory test results to date, nasopharyngeal swab Day 15 to check for SARS-CoV-2 
infection (reverse transcription polymerase chain reaction [RT-PCR] result must be received 
by the CRU and negative prior to the second vaccine administration), medical history since 
last visit including AE assessment for SAEs, Grade 3 AEs, or AESIs that are possibly, 
probably, or definitely related to study vaccine without a plausible alternative explanation, 
targeted physical examination, recheck of eligibility criteria, and pregnancy test (as 
applicable). 
Subjects will be monitored for SARS-CoV-2 exposure for potential asymptomatic infection 
throughout the study.  
• 
If a subject has a positive or borderline ELISA anti-N IgG result, sites should have the 
subject return for an unscheduled PCR. If the ELISA is positive and the PCR is 
negative, the sites should follow the subjects using the standard of care under 
Investigator discretion, retesting ELISA at the next study visit(s) or sooner (per the 
Investigator’s decision). 
• 
If the subject has a positive or borderline ELISA anti-N IgG AND a positive PCR test, 
the clinical sites should bring the subjects back for repeat PCR testing as described 
below. 
• 
The clinical sites should continue to collect PCR tests if a subject is experiencing 
possible COVID-19 symptoms, or had possible exposure to SARS-CoV-2 (ie, close 
contact tests positive for SARS-CoV-2). Testing will occur every 2 weeks for a total of 
4 weeks (if 2 consecutive negative tests) or until negative (x2) after a positive result. 
Positive results will be reported as an AESI and subjects followed for disease severity, 
duration, and outcome. 
Subjects who are seropositive for SARS-CoV-2 and asymptomatic will be allowed to enroll 
into Parts A and B of the study as long as the subject is RT-PCR negative. 
Interim Safety Data Reviews: 
For all of the sentinel groups, the iSRC will meet to review the sentinel subjects’ safety and 
tolerability data through Day 8. In the event that iSRC has not met for the post Day 8 review 
because the entire sentinel group (n = 3) has not completed Day 8 before a sentinel subject 

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is to receive the second vaccine on Day 22, the iSRC will meet on an ad hoc basis, to ensure 
there are no safety concerns and that none of the Individual Discontinuation Criteria or Study 
Halting Rules have been met, prior to the sentinel subjects receiving the second vaccine. 
When all subjects in Part A (18-49 years) low dose have received the first vaccination and 
have all safety data through Day 8, the iSRC will convene and review the safety data to 
ensure that there are no safety concerns and that none of the Study Halting Rules have been 
met before recommending that the study enroll Part A high dose and Part B low dose. The 
same strategy will be used for Part B when going from low to high dose.  
The iSRC will be asked to review unblinded immunogenicity and safety data when the first 
30 subjects vaccinated in the Part A low dose group (including active and placebo subjects) 
have data available from Day 1 through Day 43 for an assessment of the risk-benefit of the 
trial.  
The iSRC will also meet when a minimum of 23 subjects have completed Day 29 after the 
second vaccination for Part A (low and high dose) and for Part B (low and high dose) to 
review safety data to ensure that there are no concerns. 
The iSRC will also review all data through Day 43 for Part A and for Part B in both dose 
groups to monitor for ongoing safety concerns and immunogenicity analysis. When the Parts 
A and B Day 43 (low and high dose) review is complete, the iSRC will recommend a dose 
for the Part C Expansion (optional). Progression to Part C will only take place after the 
Center for Biologics Evaluation and Research (CBER) has had the opportunity to review the 
Day 43 data from Parts A and B and concurs with the plan to proceed with enrollment. 
Study Halting Rules: 
The occurrence and confirmation of 1 or more of the following findings will result in 
suspension of further enrollment and study vaccine administration pending urgent review 
(within 1 week) of the safety data by the iSRC. Subjects who are withdrawn from study 
vaccine (if applicable) will continue to be monitored for safety and immunogenicity. 
• 
One or more subjects experience an SAE assessed as possibly related, probably related, 
or related to study vaccine without a plausible alternative explanation. 
• 
One or more subjects have generalized urticaria during the 7-day post vaccination 
period. 
• 
One or more subjects develop a Grade 4 local reaction for which there is no alternative 
plausible explanation.  
• 
One or more subjects experience laryngospasm, bronchospasm, or anaphylaxis after 
vaccine administration considered related to the vaccine.  
• 
One or more subjects develop a fever >40°C/104°F during the 7 days post vaccination 
period that is assessed as possibly related, probably related, or related to study vaccine 
without a plausible alternative explanation. 
• 
Two or more subjects within an individual treatment group, or 2 or more subjects across 
treatment groups, experience any Grade 3 or higher abnormality in the same laboratory 
parameter determined by the Investigator or medical monitor as clinically significant 
and that are assessed as possibly related, probably related, or related to study vaccine 
without a plausible alternative explanation.  
• 
Two or more subjects across treatment groups experience a Grade 3 or higher AE, 
MAAE, or AESI of the same or similar preferred terms (as categorized by the Medical 
Dictionary for Regulatory Activities [MedDRA]) assessed as possibly related, probably 
related, or related to study vaccine without a plausible alternative explanation. 
• 
Any subject with severe SARS-CoV-2 infection will be assessed for the possibility of 
vaccine-associated enhanced respiratory disease. Severe SARS-CoV-2 infection is 
defined as individuals who have virologically confirmed SARS-CoV-2 infection with 
any of the following: 
o 
Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30 
breaths per minute, heart rate ≥ 125 bpm, oxygen saturation (SpO2) ≤ 93% on room 

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air at sea level or partial pressure of oxygen/ fraction of inspired oxygen 
(PaO2/FiO2) < 300 mmHg) 
o 
Respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, 
mechanical ventilation or extracorporeal membrane oxygenation [ECMO]) 
o 
Evidence of shock (systolic blood pressure < 90 mmHg, diastolic blood pressure 
< 60 mmHg, or requiring vasopressors) 
o 
Significant acute renal, hepatic, or neurologic dysfunction 
o 
Admission to an intensive care unit (ICU) 
o 
Death due to SARS-CoV-2 infection 
The iSRC will review unblinded safety data for any subject who dies, requires ICU 
admission due to SARS-CoV-2 infection, develops an AESI of autoimmune disease or 
potential immune-medicated medical condition, or experiences vaccine-associated enhanced 
respiratory disease. If the subject had received TAP-COVID-19, the iSRC may decide 
whether a study halt for vaccine-enhanced disease is required based on a review of all 
available clinical and preclinical safety and immunogenicity data. 
 
PART C EXPANSION (OPTIONAL): 
The Part C Expansion may be conducted to confirm the safety and immunogenicity of a 
selected dose across the broad target age span using a larger sample size. The proposed 
sample size was selected based on World Health Organization (WHO) guidelines on clinical 
evaluation of vaccines: regulatory expectations Annex I (2001), which states that 
approximately 300 subjects are needed to identify common local reactogenicity events. A 
larger sample size will assist in a better characterization of kinetics and range of immunity 
(neutralizing antibody titers) and provide a more reliable output of seropositivity and 
seroconversion to TAP-COVID-19 immunization. With the limited clinical experience with 
SARS-CoV-2 vaccines and the current lack of a biomarker correlate of protection, the 
generation of this larger data set is relevant to inform the design and implementation of a 
Phase 3 program. After review of safety and immunogenicity data from Parts A and B 
through Day 43, a dose for the Phase II expansion study will be recommended by the iSRC. 
Progression to Part C will only take place after CBER has had the opportunity to review the 
human clinical plus additional nonclinical data and concurs with the plan to proceed with 
enrollment. Subjects ≥18 years of age will be enrolled and randomized 1:1 (selected active 
dose:placebo). Up to 1000 subjects will be enrolled at the chosen dose to provide expanded 
dose confirmation, safety, and immunogenicity data. Although all subjects in Part C will 
have safety laboratory tests performed at screening, only the first 200 subjects in Part C will 
have safety laboratory tests performed at all post-dose time points. The remaining subjects 
in Part C will not have safety laboratory tests performed at any of the post-dose time points 
unless the Investigator deems it necessary. 
Subjects who are seropositive for SARS-CoV-2 and asymptomatic will be allowed to enroll 
into Part C of the study. 
Study Rationale: 
Multiple vaccines have been approved for emergency use for the prevention of 
SARS-CoV-2, with other vaccines close to being available either through emergency use or 
licensed vaccines. Although work continues on antiviral treatments for SARS-CoV-2, given 
the crisis of COVID-19 infections in the world, the fast expansion to the United States and 
other parts of the world, and the global push to vaccinate everyone, additional sources of 
effective vaccine will be needed. 
Subject Selection 
Criteria: 
Inclusion Criteria: 
Subjects must meet all inclusion criteria to be eligible for study participation. In addition, 
racial and ethnic minorities will be sought to obtain a diverse study population. 
All Subjects 
1. Subject read, understood, and signed the informed consent form (ICF).  
2. Healthy adult males and females 18-49 years of age (Part A) or 50-85 years of age 
(Part B), inclusive, at screening. 

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3. RT-PCR negative at time of screening  
4. Body 
mass 
index 
(BMI) 
of 
≥ 
18 
and 
≤ 
30 
kg/m2 
at 
screening. 
BMI = weight (kg)/(height [m])2. 
5. Must be in general good health before study participation with no clinically relevant 
abnormalities that could interfere with study assessments.  
6. Women of childbearing potential (WOCBP) and men whose sexual partners are 
WOCBP must be able and willing to use at least 1 highly effective method of 
contraception (ie, include hysterectomy, bilateral salpingectomy, and bilateral 
oophorectomy, hormonal oral [in combination with male condoms with spermicide], 
transdermal, implant, or injection, barrier [ie, condom, diaphragm with spermicide]; 
intrauterine device; vasectomized partner [6 months minimum], clinically sterile 
partner; or abstinence) during the study.  
• 
A female subject is considered to be a WOCBP after menarche and until she is in 
a postmenopausal state for 12 consecutive months (without an alternative medical 
cause) or otherwise permanently sterile.  
• 
Note: Subjects not of childbearing potential are not required to use any other forms 
of contraception during the study. Non-childbearing potential is defined as subject 
confirmed:  
o Surgical sterilization (eg, bilateral oophorectomy, bilateral salpingectomy, 
bilateral occlusion by cautery [Essure System is not acceptable], 
hysterectomy, or tubal ligation).  
o Postmenopausal (defined as permanent cessation of menstruation for at least 
12 consecutive months prior to screening) with follicle-stimulating hormone 
≥ 30 mIU/mL at screening. 
7. WOCBP must have a negative urine pregnancy test before each vaccination. 
8. Must be able to attend all visits, including unscheduled visits if respiratory symptoms 
suggestive of SARS-CoV-2 infection develop during the study, for the duration of the 
study and comply with all study procedures, including daily completion of the Diary 
Card for 7 days after each injection. 
Exclusion Criteria: 
Subjects will not be eligible for study participation if they meet any of the exclusion criteria, 
or will be discontinued at the discretion of the Investigator if they develop any of the 
exclusion criteria during the study.  
Parts A and B 
1. History of an acute or chronic medical condition including dementia that, in the opinion 
of the Investigator, would render vaccination unsafe or would interfere with the 
evaluation of responses. Chronic conditions that are NOT included on the Center for 
Disease Control’s list of subjects at higher risk for severe illness from SARS-CoV-2 are 
acceptable if the condition has been stable for the 3 months prior to vaccine 
administration (Day 1), with no medication changes, and no hospitalization in the past 
6 months. 
2. History of any medical conditions that place subjects at higher risk for severe illness due 
to SARS-CoV-2 including but not limited to cancer, chronic kidney disease at any stage, 
chronic lung disease, dementia or other neurological conditions, diabetes (Type 1 or 
Type 2), Down syndrome, heart conditions, human immunodeficiency virus (HIV) 
infection, immunocompromised state (weakened immune system), liver disease, 
overweight/obesity, pregnancy, sickle cell disease or thalassemia, smoker (current or 
former), transplants (solid organ or blood stem cell), stroke or cerebrovascular disease, 
and substance use disorders.  
3. History of ongoing clinical condition or medication or treatments that may adversely 
affect the immune system. 
 

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4. Individuals who are RT-PCR positive for SARS-CoV-2 at screening or prior to second 
dose of TAP-COVID-19 vaccine. 
5. Individuals who are at increased risk of exposure to SARS-CoV-2 (eg, healthcare 
workers, emergency responders). 
6. Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to 
vaccine administration. 
7. Living in a group care facility (eg, assisted living or nursing home). 
8. Individuals with any elevated (Grade 1 or higher) laboratory test assessed as clinically 
significant for age by the Investigator at screening. 
9. Individuals with elevated (Grade 1 or higher) liver function enzyme at screening, may 
repeat testing once to re-assess clinical significance. If the retest comes back within 
normal range, the subject will be eligible for enrollment with Investigator and Medical 
Monitor approval. See below for the criteria for excluding subjects with elevated liver 
enzymes (once confirmed by retest): 
• 
Alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate 
aminotransferase (AST), or gamma-glutamyl transferase (GGT) >1.5 × upper limit 
of normal (ULN) 
• 
Total bilirubin >1.6 × ULN 
10. Active neoplastic disease (excluding nonmelanoma skin cancer that was successfully 
treated) or a history of any hematological malignancy. “Active” is defined as having 
received treatment within the past 5 years. 
11. Long-term (greater than 2 weeks) use of oral or parenteral steroids, high-dose inhaled 
steroids (>800 μg/day of beclomethasone dipropionate or equivalent), or 
immunomodulatory drugs within 6 months before screening (nasal and topical steroids 
are allowed). 
12. History of autoimmune, inflammatory disease, or potential immune-mediated medical 
conditions (Appendix B). 
13. Women currently pregnant, lactating, or planning a pregnancy between enrollment and 
181 days after randomization. 
14. History of Guillain-Barré Syndrome.  
15. History of anaphylactic-type reaction to injected vaccines.  
16. Known or suspected hypersensitivity to 1 or more of the components of the vaccine, 
including thimerosal, tobacco, and CpG adjuvant.  
17. History of alcohol abuse, illicit drug use, physical dependence to any opioid, or any 
history of drug abuse or addiction within 12 months of screening. 
Note: In those regions where cannabis use is legal, it will be left to the discretion of the 
Investigator to decide if a subject is an occasional user or an abuser of cannabis. The 
Investigator should discuss user/abuser status on a case-by-case basis with the Medical 
Monitor prior to enrollment. 
18. Acute illness or fever within 3 days before study enrollment (enrollment may be delayed 
for full recovery if acceptable to the Investigator).  
19. Individuals currently participating or planning to participate in a study that involves an 
experimental agent (vaccine, drug, biologic, device, or medication); or who have 
received an experimental agent within 1 month (3 months for immunoglobulins) before 
enrollment in this study; or who expect to receive another experimental agent during 
participation in this study. 
20. Receipt of immunoglobulin or another blood product within the 3 months before 
enrollment in this study or those who expect to receive immunoglobulin or another blood 
product during this study.  
21. Individuals who intend to donate blood within 6 months after the first vaccination.  
22. Individuals using prescription medications for prophylaxis of SARS-CoV-2. 

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23. Individuals who plan to receive another vaccine within the first 3 months of the study 
except influenza vaccine which should not be given within 2 weeks of study vaccine.  
24. Receipt of any other approved SARS-CoV-2 vaccine prior to the first study vaccine or 
within 90 days after administration of the first study vaccine. 
25. Receipt of any other experimental coronavirus vaccine at any time prior to or during the 
study.  
26. Receipt of any investigational vaccine or drug within 1 month of enrollment and through 
the end of the study (1 year after first vaccination). 
27. Plan to travel outside the subjects’ country of residence from enrollment through 
Day 43.  
28. History of surgery or major trauma within 12 weeks of screening, or surgery planned 
during the study. 
29. Significant blood loss (>450 mL) or has donated 1 or more units of blood or plasma 
within 6 weeks prior to study participation. 
30. Strenuous activity (as assessed by the Investigator) within 48 hours prior to dosing 
(Days 1 and 22). 
31. A positive urine drug screen without evidence of corresponding prescribed concomitant 
medication(s) at Screening. Note: A positive drug screen result with a corresponding 
prescribed concomitant medication will be allowed if, in the opinion of the investigator 
and Medical Monitor, the concomitant medication does not make the subject unsuitable 
to participate in the clinical trial. For a positive tetrahydrocannabinol result, refer to 
Exclusion Criteria #17. 
32. Positive alcohol screen. 
33. Positive screen for HIV-1 and HIV-2 antibodies, hepatitis B surface antigen (HBsAg), 
or hepatitis C virus (HCV) antibody. 
34. Involved in the planning or conduct of this study. 
35. Unwilling or unlikely to comply with the requirements of the study. 
36. Subject is an employee, contractor, friend of or relative of any employee of Sponsor, 
contract research organization (CRO), study site or site affiliate. 
Part C 
If the study proceeds to the Part C Expansion study, the following exclusion criteria 
(Number, from Parts A and B) will be not applicable. 
(5) Individuals who are at increased risk of exposure to SARS-CoV-2 (eg, healthcare 
workers, emergency responders). 
(6) Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior 
to vaccine administration. 
(7) Living in a group care facility (eg, assisted living or nursing home). 
(31) A positive urine drug screen without evidence of corresponding prescribed 
concomitant medication(s) at Screening. Note: A positive drug screen result with a 
corresponding prescribed concomitant medication will be allowed if, in the 
opinion of the investigator and Medical Monitor, the concomitant medication does 
not make the subject unsuitable to participate in the clinical trial.  
(32) Positive alcohol screen. 
(33) Positive screen for HIV-1 and HIV-2 antibodies, HBsAg, or HCV antibody (Parts A 
and B). For Part C, subjects known to be HIV positive or have active Hepatitis B or 
C infection will be excluded.  
Study Vaccine, Dose, 
and 
Route 
of 
Administration: 
TAP-COVID-19: 0.5 mL of TAP-COVID-19 vaccine at 15 μg or 45 μg + CpG (0.5 mg), 
administered by IM injection on Day 1 and Day 22 (±3 days). 

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Reference 
Vaccine, 
Dose and Route of 
Administration: 
Placebo: 0.5 mL buffered saline solution, administered by IM injection on Day 1 and Day 22 
(±3 days). 
Planned Sample Size: No formal sample size calculation was performed.  
A total of 180 subjects will be enrolled in Parts A and B. Approximately 90 eligible subjects 
(aged 18-49 years), with 30 subjects per treatment group for Part A and 90 eligible subjects 
(aged 50-85 years), with 30 subjects per treatment for Part B, will be enrolled in the study.  
An optional Part C Expansion may be conducted to confirm the safety and immunogenicity 
of the selected dose of vaccine in up to 1000 adult subjects randomized 1:1 (single dose level 
of study vaccine:placebo). The proposed sample size was selected based on WHO guidelines 
on clinical evaluation of vaccines: regulatory expectations Annex I (2001), which states that 
approximately 300 subjects are needed to identify common local reactogenicity events. A 
larger sample size will assist in a better characterization of kinetics and range of immunity 
(neutralizing antibody titers) and provide a more reliable output of seropositivity and 
seroconversion to TAP-COVID-19 immunization. With the limited clinical experience with 
SARS-CoV-2 vaccines and the current lack of a biomarker correlate of protection, the 
generation of this larger data set is relevant to inform the design and implementation of a 
Phase 3 program. 
Statistical Analysis: 
Analysis Populations:  
Enrolled Population: All subjects who signed the ICF.  
Safety Population: All subjects who provided consent, are randomized, and received any 
amount of study vaccine/placebo. The Safety Population will be used for the demographic, 
baseline characteristic, safety data summaries, and the analysis of primary endpoints such as 
occurrence of solicited local and systemic reactogenicity. 
Per Protocol (PP) Population: Includes all subjects in the Safety Population who receive the 
assigned doses of the study vaccine/placebo according to protocol, have serology results, 
and have no major protocol deviations affecting the primary immunogenicity outcomes, as 
determined by the Sponsor before database lock and unblinding. Subjects that are immunized 
with an approved vaccine will be captured as a subset analysis of the PP Population at 
Days 90, 181, 273, and 365 based on the date of receiving an approved COVID-19 vaccine. 
Modified Intent-to-Treat (mITT) Population: Includes all subjects in the Safety Population 
who provide any serology data. The mITT Population will be used for immunogenicity 
analysis.  
Immunogenicity Analysis: 
The mITT Population will be used for all listings and summary statistics corresponding to 
immunogenicity analysis.  
The individual sampling and blood collection for ELISA analysis to determine IgG and IgM 
antibody titers to the spike RBD and neutralizing antibody titers for parent (Wuhan) and any 
variant SARS-CoV-2 strains, will be listed and summarized by time points for each part by 
treatment.  
All derived immunogenicity secondary endpoint parameters: GMT, GMT ratio, GMFR, 
GMI, and seroconversion rates will be listed and summarized by scheduled time point using 
descriptive statistics (n, mean, standard deviation, minimum, median, maximum, geometric 
mean, coefficient of variation (percentage) (CV%), geometric coefficient of variation 
(percentage) (GeoCV%), and 95% confidence interval) for each part by treatment. 
PBMC and serum sample data for future research results at each scheduled visit will also be 
provided separately in a listing and summary table, if applicable. 
Graphical display of the summary results or at individual time points will be provided as 
needed (eg, scatter plots of subject titer values to visually display individual data points). 
 
 

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Protocol Number: KBP-201 
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CONFIDENTIAL 
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Cellular Analysis: 
The number of IFN-γ and IL-5 producing T-cells (CD4+ and CD8+) from PBMCs 
responsive to vaccine antigens will be listed and summarized by time point using appropriate 
descriptive statistics for each part by treatment. 
Safety Analysis:  
Safety Population will be used for all safety variables specified.  
All safety data will be summarized by part and treatment. No statistical tests will be 
performed. 
In addition, if any subjects seropositive for SARS-CoV-2 are enrolled, safety and efficacy 
subgroup analysis will be performed for this group of subjects. 
 
 

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Protocol Number: KBP-201 
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CONFIDENTIAL 
12 November 2021 
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1.1 
Schedule of Assessments and Procedures 
Table 1-1 
Schedule of Assessments and Procedures 
Study Visit SCR Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 
Visit 8 
Visit 9 
Visit 10 Visit 11 Visit 12 
Visit 13 
Study  
End 
UNSCH
/ET 
Study Day 
(Visit 
Window) 
 
Procedures 
Day  
-14  
to  
Day -1 Day 1 
Day 8  
(±1 
Day) 
Day 
15  
(±1 
Day) 
Day 
22 (±3 
Days) 
Day 
29 
(±2 
Days) 
Day 
43 (±2 
Days) 
Day 76  
(±3 
Days) 
Day 90  
(±14 
Days) 
Day 120 
(±3 
Days) 
Day 150 
(±3 
Days) 
Day 181 
(±14 
Days) 
Day 273 
(±14 
Days) 
Day 365 
(±14 
Days) 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eligibility 
X 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Medical history 
X 
X a 
X a 
X a 
X a 
X a 
X a 
 
X a 
 
 
X a 
X a 
X a 
X a 
Demographic and 
baseline 
characteristics b 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Complete physical 
examination 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Targeted physical 
examination c 
 
X 
X 
X 
X 
X 
X 
 
 
 
 
X 
 
 
X 
Height, weight, BMI 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vital sign 
measurements d 
X 
X d 
X 
X 
X d 
X 
X 
 
X 
 
 
X 
X 
X 
X 
Urine pregnancy test e 
X 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Urine drug screen f 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HIV-1/2, HBsAg, 
HCV g 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Nasopharyngeal swab 
for RT-PCR h 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
X 
Serostatus  
(IgM & IgG) for 
SARS-CoV-2 q 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Oral Temperature 
(pre-vaccination) 
 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 

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Protocol Number: KBP-201 
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CONFIDENTIAL 
12 November 2021 
Page 13 
Study Visit SCR Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 
Visit 8 
Visit 9 
Visit 10 Visit 11 Visit 12 
Visit 13 
Study  
End 
UNSCH
/ET 
Study Day 
(Visit 
Window) 
 
Procedures 
Day  
-14  
to  
Day -1 Day 1 
Day 8  
(±1 
Day) 
Day 
15  
(±1 
Day) 
Day 
22 (±3 
Days) 
Day 
29 
(±2 
Days) 
Day 
43 (±2 
Days) 
Day 76  
(±3 
Days) 
Day 90  
(±14 
Days) 
Day 120 
(±3 
Days) 
Day 150 
(±3 
Days) 
Day 181 
(±14 
Days) 
Day 273 
(±14 
Days) 
Day 365 
(±14 
Days) 
 
Vaccination dose 
(IM) 
 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
60 minute 
post-vaccination 
monitoring (arm 
check, VS, and 
targeted PE if general 
symptoms present) 
 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Distribution and 
training on Diary 
Card completion 
 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Review of  
Diary Card i 
 
 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
Telephone visit j 
 
 
 
 
 
 
 
X 
 
X 
X 
 
 
 
 
SARS-Cov-2 
exposure and 
asymptomatic 
monitoring k 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Adverse events l 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
SAEs, MAAEs, 
NOCDs and AESIs m 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Prior and concomitant 
medications n 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Clinical safety 
laboratory tests o 
X 
 
X 
X 
X 
 
X 
 
 
 
 
X 
 
 
X 
Blood collection for 
ELISA IgM and IgG 
total antibodies p 
X 
 
X 
X 
X 
X 
X 
 
X 
 
 
X 
X 
X 
X 

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Protocol Number: KBP-201 
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12 November 2021 
Page 14 
Study Visit SCR Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 
Visit 8 
Visit 9 
Visit 10 Visit 11 Visit 12 
Visit 13 
Study  
End 
UNSCH
/ET 
Study Day 
(Visit 
Window) 
 
Procedures 
Day  
-14  
to  
Day -1 Day 1 
Day 8  
(±1 
Day) 
Day 
15  
(±1 
Day) 
Day 
22 (±3 
Days) 
Day 
29 
(±2 
Days) 
Day 
43 (±2 
Days) 
Day 76  
(±3 
Days) 
Day 90  
(±14 
Days) 
Day 120 
(±3 
Days) 
Day 150 
(±3 
Days) 
Day 181 
(±14 
Days) 
Day 273 
(±14 
Days) 
Day 365 
(±14 
Days) 
 
Blood collection for 
neutralizing, anti-
RBD, and anti-Fc 
antibodies 
X 
 
X 
X 
X 
X 
X 
 
X 
 
 
X 
X 
X 
X 
Cell-mediated 
immunity (PBMC) 
X 
 
X 
 
X 
X 
X 
 
X 
 
 
X 
X 
X 
X 
PBMC and serum 
sample collection for 
future research 
X 
 
X 
 
X 
X 
X 
 
X 
 
 
X 
X 
X 
X 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; BMI = body mass index; CRU = clinical research unit; ELISA = enzyme-linked 
immunosorbent assay; ET = Early Termination visit; HBsAg = hepatitis B surface antigen; HCV = hepatitis C virus; HIV = human 
immunodeficiency virus; Ig = immunoglobulin; IM = intramuscular; MAAE = medically attended adverse event; NOCD = new-onset chronic 
disease; PBMC = peripheral blood mononuclear cells; PE = physical examination; RBD = receptor binding domain; RT-PCR = reverse 
transcription polymerase chain reaction; SAE = serious adverse event; SCR = Screening visit; UNSCH = Unscheduled visit; VS = vital signs  
a. 
Medical history will be collected to determine if any changes have occurred since last visit. 
b. Baseline characteristics include tobacco use and history. 
c. 
Post vaccination targeted physical examination includes evaluation of any system indicated by an AE complaint. 
d. Pre-dose and approximately 60 minutes post vaccination. Vital signs will be measured after the subject has been resting quietly in a seated position for at 
least 5 minutes. Vital signs measurements will include blood pressure, heart rate, respiratory rate, and oral temperature. 
e. 
A negative urine pregnancy test must be documented before vaccination on Day 1 and Day 22 for women of childbearing potential. A serum pregnancy test 
must be performed to confirm any positive urine pregnancy test. 
f. 
For Parts A and B, a positive urine drug screen without evidence of corresponding prescribed concomitant medication(s) at Screening is exclusionary. A 
positive drug screen result with a corresponding prescribed concomitant medication will be allowed if, in the opinion of the Investigator and Medical 
Monitor, the concomitant medication does not make the subject unsuitable to participate in the clinical trial. 
g. Not performed for Part C. 
h. Serial nasopharyngeal swabs (RT-PCR) will be performed on subjects that report either potential exposure to SARS-CoV-2 (ie, close contact tests positive 
for SARS-CoV-2) or symptoms of SARS-CoV-2 infection. Testing will occur every 2 weeks for a total of 4 weeks (if 2 consecutive negative tests) or until 
negative after a positive result. Positive results will be reported as an AESI (Section 8.2.2) and subjects followed for disease severity, duration, and outcome. 

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CONFIDENTIAL 
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Page 15 
i. 
Review of Diary Card (Appendix A) will include a check that the Diary Card has been completed appropriately and re-training the subjects, if necessary. 
Any illogical entries will be queried by the site and corrected if appropriate. 
j. 
During telephone visits, CRU staff will interview the subjects about any potential exposure to the virus. If a subject has had potential exposure, the CRU will 
ask the subject to come in for an unscheduled visit which will include a nasopharyngeal swab. Subjects will be reminded to contact the clinical site any time 
there is potential exposure to SARS-CoV-2. 
k. Subjects will be monitored for SARS-CoV-2 exposure for potential asymptomatic infection throughout the study. CRU staff will interview subjects about 
any potential exposure to the virus. If a subject has had potential exposure, the CRU will perform an unscheduled nasopharyngeal swab. 
l. 
Adverse events include questioning regarding the specifically elicited events on the Diary Card and complaints spontaneously reported in response to 
nondirective questions. 
m. SAEs, MAAEs, NOCDs, and AESIs will be collected from Day 1 through Day 365/approximately 1 year after first vaccination. 
n. Includes all medications taken during the first 43 days of the study, including those started 30 days before and ongoing at vaccination. 
o. Refer to Table 7-1 for a detailed list of clinical laboratory test parameters. Clinical laboratory tests can be repeated once at screening to confirm an 
out-of-range result. If Part C Expansion (optional) is performed, safety laboratory tests will be performed at screening for all Part C subjects in order to 
satisfy the inclusion/exclusion criteria. In addition, the first 200 subject in Part C will have safety laboratory tests performed at all time points. The remaining 
subjects in Part C will not have safety laboratory tests performed at any of the post-dose time points unless the Investigator deems it necessary.  
p. Subjects with positive ELISA anti-N IgG results without COVID-19 symptoms may indicate asymptomatic SARS-CoV-2 infection and will be followed 
appropriately. Subjects with a positive ELISA anti-N IgG result should have a PCR test and be followed until both are negative as in the protocol instructions 
(Section 7.6). 
q. Serostatus will not be used to determine eligibility; however, subjects with a positive serostatus for SARS-CoV-2 will have safety and efficacy subgroup 
analysis performed. 
NOTE: In the event multiple post-dose procedures are required to be conducted at the same nominal time point, the timing of antibody titer and cellular 
immunity blood sample collections will take priority over all other scheduled activities. In practice, the following order is recommended: (1) vital signs 
measurements; (2) antibody titer and cellular immunity blood sampling; (3) clinical laboratory tests sampling; (4) physical examination and height and 
body weight measurements. Vital signs may be conducted up to 10 minutes, prior to the nominal time to minimize the potential autonomic effects of blood 
draws on these measurements and remaining assessments (eg, clinical laboratory tests sampling, physical examination, and height and body weight 
measurements) may be performed after the nominal time point. 

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Protocol Number: KBP-201 
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CONFIDENTIAL 
12 November 2021 
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TABLE OF CONTENTS 
1 
SYNOPSIS .....................................................................................................................2 
1.1 
Schedule of Assessments and Procedures..............................................................12 
TABLE OF CONTENTS ............................................................................................................16 
LIST OF TABLES .......................................................................................................................18 
LIST OF FIGURES .....................................................................................................................18 
LIST OF ABBREVIATIONS .....................................................................................................19 
STUDY ADMINISTRATIVE STRUCTURE ...........................................................................21 
2 
INTRODUCTION AND BACKGROUND ...............................................................22 
2.1 
Introduction ............................................................................................................22 
2.2 
Study Vaccine Background....................................................................................22 
2.2.1 
Receptor Binding Domain Vaccine Strategy .........................................................22 
2.2.2 
TAP-COVID-19 Vaccine – A Novel Vaccine for COVID-19 Disease 
Prevention ..............................................................................................................22 
2.2.3 
CpG Adjuvant ........................................................................................................23 
2.2.4 
Data Supporting Development of TAP-COVID-19 Vaccine ................................23 
2.3 
Summary of Findings to Date ................................................................................24 
2.4 
Study Rationale ......................................................................................................25 
2.5 
Dose Rationale .......................................................................................................25 
3 
OBJECTIVES AND ENDPOINTS ...........................................................................26 
3.1 
Objectives ..............................................................................................................26 
3.1.1 
Primary Objective ..................................................................................................26 
3.1.2 
Secondary Objectives.............................................................................................26 
3.1.3 
Exploratory Objectives ..........................................................................................26 
3.2 
Endpoints ...............................................................................................................26 
3.2.1 
Primary Endpoints .................................................................................................26 
3.2.2 
Secondary Endpoints .............................................................................................27 
3.2.3 
Exploratory Endpoints ...........................................................................................27 
4 
STUDY DESIGN .........................................................................................................28 
4.1 
Study Design and Overview ..................................................................................28 
4.1.1 
Duration of Study ...................................................................................................32 
4.1.2 
Interim Safety Data Review ...................................................................................32 
4.1.3 
Definition of Study Completion.............................................................................33 
4.1.4 
End of Study ..........................................................................................................33 
5 
SELECTION AND WITHDRAWAL OF SUBJECTS ...........................................34 
5.1 
Inclusion Criteria ...................................................................................................34 
5.2 
Exclusion Criteria ..................................................................................................35 
5.3 
Screen Failures .......................................................................................................38 
5.4 
Decision to Administer Second Vaccination .........................................................38 
5.5 
Individual Discontinuation Criteria .......................................................................39 
5.6 
Subject Withdrawal ................................................................................................39 
5.7 
Independent Safety Review Committee, Study Stopping Rules, and Study 
Termination ............................................................................................................40 

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5.7.1 
Independent Safety Review Committee.................................................................40 
5.7.2 
Study Halting Rules ...............................................................................................41 
5.7.3 
Study Termination .................................................................................................42 
6 
TREATMENT OF SUBJECTS .................................................................................44 
6.1 
Identity of Study Vaccines .....................................................................................44 
6.2 
Treatments Administered .......................................................................................44 
6.3 
Method of Assigning Subjects to Treatment Groups .............................................45 
6.4 
Measurements of Treatment Compliance ..............................................................45 
6.5 
Study Vaccine Storage, Accountability, and Retention .........................................45 
6.5.1 
Storage Conditions .................................................................................................45 
6.5.2 
Drug Accountability and Retention .......................................................................45 
6.6 
Packaging and Labeling .........................................................................................45 
6.6.1 
Study Vaccine ........................................................................................................45 
6.6.2 
Blinding of Treatment Assignment ........................................................................46 
6.6.3 
Unblinding of Treatment Assignment ...................................................................46 
6.7 
Concomitant Medications and Procedures and Other Restrictions ........................47 
6.7.1 
Concomitant Medications and Procedures.............................................................47 
6.7.2 
Other Restrictions ..................................................................................................47 
7 
STUDY ASSESSMENTS AND PROCEDURES .....................................................48 
7.1 
Pandemic Safety Procedures ..................................................................................48 
7.2 
Medical and Surgical History ................................................................................48 
7.3 
Demographic Characteristics .................................................................................48 
7.4 
Physical Measurements ..........................................................................................48 
7.5 
Immunogenicity .....................................................................................................48 
7.6 
SARS-CoV-2 Exposure and Asymptomatic Monitoring .......................................49 
7.7 
Safety Assessments ................................................................................................49 
7.7.1 
Adverse Events ......................................................................................................49 
7.7.2 
Reactogenicity Assessments ..................................................................................50 
7.7.3 
Laboratory Tests ....................................................................................................50 
7.7.4 
Vital Signs ..............................................................................................................51 
7.7.5 
Physical Examination.............................................................................................52 
7.7.6 
Appropriateness of Safety Assessments ................................................................52 
8 
ADVERSE EVENTS ...................................................................................................53 
8.1 
Recording Adverse Events .....................................................................................53 
8.2 
Assessment of Adverse Events ..............................................................................54 
8.2.1 
Serious Adverse Events, Medically Attended Adverse Events, New Onset 
Chronic Medical Conditions, Adverse Events of Special Interest, and Potential 
Immune-mediated Conditions ................................................................................54 
8.2.2 
Adverse Events of Special Interest ........................................................................54 
8.2.3 
Intensity..................................................................................................................55 
8.2.4 
Relationship to Study Vaccine ...............................................................................55 
8.3 
Discontinuation Due to Adverse Events ................................................................56 
8.4 
Reporting Serious Adverse Events and Adverse Events of Special Interest .........56 
8.5 
Pregnancy ...............................................................................................................56 
8.6 
Drug-induced Liver Injury .....................................................................................57 

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9 
STATISTICAL CONSIDERATIONS ......................................................................58 
9.1 
Sample Size Calculation ........................................................................................58 
9.2 
Analysis Populations ..............................................................................................58 
9.3 
Randomization .......................................................................................................59 
9.4 
Endpoints ...............................................................................................................60 
9.5 
Interim Analyses ....................................................................................................60 
9.6 
Immunogenicity Analysis ......................................................................................60 
9.7 
Cellular Analysis ....................................................................................................61 
9.8 
Safety Analysis ......................................................................................................61 
10 
ACCESS TO SOURCE DATA/DOCUMENTS .......................................................62 
11 
QUALITY CONTROL AND QUALITY ASSURANCE ........................................63 
11.1 
Conduct of Study ...................................................................................................63 
11.1.1 
Protocol Deviations ................................................................................................63 
11.2 
Protocol Amendments ............................................................................................63 
11.3 
Monitoring of Study ...............................................................................................63 
12 
ETHICS ........................................................................................................................65 
12.1 
Institutional Review Board Approval ....................................................................65 
12.1.1 
Ethics Review Prior to Study .................................................................................65 
12.1.2 
Ethics Review of Other Documents .......................................................................65 
12.2 
Written Informed Consent .....................................................................................65 
13 
DATA HANDLING AND RECORD KEEPING .....................................................66 
13.1 
Data Reporting and Case Report Forms ................................................................66 
13.1.1 
Case Report Forms .................................................................................................66 
13.1.2 
Laboratory Data .....................................................................................................66 
13.1.3 
Retention of Source Documents ............................................................................66 
13.2 
Retention of Essential Documents .........................................................................66 
14 
ADMINISTRATIVE INFORMATION ....................................................................67 
14.1 
Financing and Insurance ........................................................................................67 
14.2 
Publication Policy ..................................................................................................67 
15 
REFERENCES ............................................................................................................68 
16 
SIGNATURES .............................................................................................................70 
APPENDIX A 
DIARY CARD EXAMPLE ............................................................................72 
APPENDIX B 
POTENTIAL IMMUNE-MEDIATED MEDICAL CONDITIONS ..........74 
APPENDIX C 
ADDITIONAL ELISA DETAILS .................................................................77 
 
List of Tables 
Table 1-1 
Schedule of Assessments and Procedures..............................................................12 
Table 6-1 
Study Vaccines.......................................................................................................44 
Table 7-1 
Clinical Safety Laboratory and Screening Tests ....................................................51 
Table 8-1 
DAIDS Adverse Events Intensity Assessment ......................................................55 
 
List of Figures 
Figure 4-1 
Study Schematic for Parts A and B........................................................................29 
  

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CONFIDENTIAL 
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Page 19 
LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
ACE-2 
angiotensin converting enzyme 2 
ADE 
antibody-mediated disease enhancement 
AE 
adverse event 
AESI 
adverse event of special interest 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
API 
active pharmaceutical ingredient 
AST 
aspartate aminotransferase 
BMI 
body mass index 
CBER 
Center for Biologics Evaluation and Research 
CDC 
Centers for Disease Control and Prevention 
CD4+ 
white blood cell T helper cell subtype 
CD8+ 
white blood cell T cytotoxic cell subtype 
CFR 
Code of Federal Regulations 
cGMP 
current Good Manufacturing Practice 
CI 
confidence interval 
CoV 
coronavirus 
CpG 
Cytosine PhosphoGuanine 
CPMP 
Committee for Proprietary Medicinal Products 
CRA 
clinical research associate 
CRU 
clinical research unit 
CRO 
contract research organization 
CSR 
clinical study report 
CV% 
coefficient of variation (percentage) 
DAIDS 
Division of AIDS 
DILI 
drug-induced liver injury 
DNA 
deoxyribonucleic acid 
ECG 
electrocardiogram 
ECMO 
extracorporeal membrane oxygenation 
eCRF 
electronic case report form 
ELISA 
enzyme-linked immunosorbent assay 
EOS 
end-of-study 
FcγRII 
Fc gamma region II of IgG 
FDA 
Food and Drug Administration 
FIH 
first-in-human 
FiO2 
fraction of inspired oxygen 
FSH 
follicle-stimulating hormone 
GeoCV% 
geometric coefficient of variation (percentage) 
GGT 
gamma-glutamyl transferase 
GMFR 
geometric mean fold rise 
GMI 
geometric mean increase 
GMT 
geometric mean titer 
H1N1 
influenza A virus subtype H1N1 
H3N2 
influenza A virus subtype H3N2 

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Protocol Number: KBP-201 
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CONFIDENTIAL 
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Page 20 
Abbreviation 
Definition 
HBsAg 
hepatitis B surface antigen 
HCV 
hepatitis C virus 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HIV 
human immunodeficiency virus 
ICD 
International Classification of Diseases 
ICF 
informed consent form 
ICU 
intensive care unit 
Ig 
immunoglobulin 
IL 
interleukin 
IM 
intramuscular 
IRB 
institutional review board 
IFN-γ 
interferon gamma 
iSRC 
independent safety review committee 
KBP 
Kentucky BioProcessing, Inc. 
MAAE 
medically attended adverse event 
MedDRA 
Medical Dictionary for Regulatory Activities 
MERS-CoV 
Middle East Respiratory Syndrome coronavirus 
mITT 
Modified Intent-to-Treat Population 
NOCD 
new onset chronic disease 
PaO2 
partial pressure of oxygen 
PBMC 
peripheral blood mononuclear cell 
PE 
physical examination 
PP 
Per Protocol  
RBD 
receptor binding domain 
RBD-Fc 
fusion protein containing RBD fused to the Fc domain of a human IgG1 
RT-PCR 
reverse transcription polymerase chain reaction 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
SOP 
standard operating procedure 
SpO2 
oxygen saturation 
SRM 
study reference manual 
SSP 
study-specific procedure 
TAP 
Tobacco Mosaic Virus Antigen Presentation 
TAP-COVID-19 Tobacco Mosaic Virus Antigen Presentation SARS-CoV-2 virus Receptor Binding Domain 
fused to Fc Domain 
TEAE 
treatment-emergent adverse event 
TLR9 
Toll-like Receptor 9 
TMV 
Tobacco Mosaic Virus 
ULN 
upper limit of normal 
US or USA 
United States of America 
VS 
vital signs 
WHO 
World Health Organization 
WOCBP 
Women of childbearing potential 

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Protocol Number: KBP-201 
Protocol Version 9.0 
 
CONFIDENTIAL 
12 November 2021 
Page 21 
STUDY ADMINISTRATIVE STRUCTURE 
Sponsor: 
Kentucky BioProcessing, Inc.  
3700 Airpark Drive 
Owensboro, KY 42301 USA 
Telephone: 270-689-257 
Sponsor’s Contact: 
Oscar (Tony) A. Guzman, MD, CP 
Clinical Project Lead 
Kentucky BioProcessing, Inc. 
ICON Medical Monitor: 
Bart Chapman, MD 
ICON Clinical Research, LLC 
820 West Diamond Avenue, Suite 100 
Gaithersburg, MD 20878 USA 
ELISA (IgM & IgG) Antibody Titer and 
Cell Mediated Immunity Laboratories: 
VisMederi srl 
Strada del Petriccio e Belriguardo, 35, 
53100 Siena, Italia  
ICON Central Laboratory 
123 Smith Street 
Farmingdale, NY 11735 USA 
Neutralizing Antibody Laboratory: 
VisMederi srl 
Strada del Petriccio e Belriguardo, 35, 
53100 Siena, Italia 
Clinical Research Organization:  
ICON Clinical Research, LLC 
820 West Diamond Avenue, Suite 100 
Gaithersburg, MD 20878 USA 
Telephone: 301-944-6800 
Multiple clinical sites may be utilized for Parts A and B. Multiple sites are also planned for 
Part C. 

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Page 22 
2 
INTRODUCTION AND BACKGROUND 
2.1 
Introduction 
To date, seven CoVs capable of human infection have been identified, including SARS-CoV, 
MERS-CoV, and a newly identified CoV (SARS-CoV-2). These 3 viruses, when in the human 
population, are significant public health risks showing high fatality rates: SARS-CoV = 10%, 
MERS-CoV = 34.4% and SARS-CoV-2 = 6.1%. The SARS-CoV-2 virus has spread to 
>180 countries since December 2019, infected >5.7 million humans, and been attributed to 
>350,000 deaths worldwide [John Hopkins 2020]. These numbers are growing exponentially, 
creating worldwide health and economic crises. The emergence of this disease and its effects on 
human health and economic security demands urgent response. 
TAP-COVID-19 Vaccine is being developed for the prevention of SARS-CoV-2 infection in 
healthy adults aged 18 and older. For this Phase 1 Study, the TAP-COVID-19 vaccine will be 
evaluated with a CpG adjuvant based on preclinical studies showing it provides a Th1 biased 
immune response against SARS-CoV-2. 
2.2 
Study Vaccine Background 
2.2.1 
Receptor Binding Domain Vaccine Strategy 
Focusing CoV vaccine efforts around the RBD (S1 domain) of the spike glycoprotein have 
produced encouraging outcomes. SARS-CoV RBD has been shown to bind the human receptor 
for ACE-2, contains multiple conformation-dependent epitopes that can elicit high-titer 
neutralizing antibodies [Wang 2020; Kam 2007; Jaume 2012; Quinlan 2020]. Most relevant to the 
KBP vaccine strategy, in vivo studies showed that a fusion protein containing RBD-Fc elicited 
high levels of neutralizing antibodies against SARS-CoV in both immunized rabbits and mice. 
These antibodies blocked spike interaction with the human receptor ACE-2. Most interestingly, 
the RBD-Fc protein induced long lasting, potent neutralizing antibody titers maintained for 
12 months after immunization – even protecting most vaccinated mice from SARS-CoV challenge 
[Du 2007; Du 2009]. Importantly, many different versions of SARS or MERS-RBD vaccines have 
been developed and tested, alone and with adjuvant, produced in mammalian cells, and insect cells 
and plants. All have shown protection from infection through virus neutralization without 
accompanying immunopathology associated with full-length or trimerized S protein vaccines 
[Wang 2020; Kam 2007; Jaume 2012; Quinlan 2020]. 
2.2.2 
TAP-COVID-19 Vaccine – A Novel Vaccine for COVID-19 Disease 
Prevention 
Based on the prior experience with Coronavirus family viruses described above, KBP has 
developed the RBD-Fc antigen linked to its novel TAP platform to accelerate development of an 
effective and scalable vaccination strategy. The KBP platform combines the well-established 
speed and robustness of its transient Nicotiana benthamiana gene expression system with the 
immune stimulation effects of antigen-association with the inactivated TMV virus structure. Using 
standardized gene expression and downstream processing strategies, while maintaining a warm 

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base of naïve plants, the TAP platform has the potential to rapidly deliver vaccines with significant 
production potential of millions of doses of vaccine API per month.  
Historical preclinical data illustrates the ability of TAP vaccines to provide balanced humoral and 
cellular responses in mammals allowing efficacious responses to be generated against a wide range 
of pathogens with different immune correlates of protection [McCormick 2006a; McCormick 
2006b; Banik 2015; Arnaboldi 2016; Mallajosyula 2016; Mallajosyula 2014].  
The TAP vaccine system offers key advantages of:  
• Speed: <10 weeks from sequence to cGMP vaccine  
• Balanced immune response: effective stimulation of both Th1 and Th2 arms of the immune 
system 
• Stability: showing room temperature shelf life past 6-months at room temperature with no 
loss of potency  
• Scalability: potential to deliver millions of doses of vaccine API per month 
• Robustness: showing safety in murine, ferret, and rabbit preclinical models and efficacy 
against challenge with seven viruses and three bacterial pathogens, including human 
influenza virus, Yersinia pestis, Francisella tularensis, and Mycobacterium tuberculosis 
2.2.3 
CpG Adjuvant 
The TAP-COVID-19 Vaccine will be combined with CpG 7909 adjuvant. CpG 7909 is a short 
(24 nucleotide) synthetic form of DNA that mimics bacterial and viral genetic material that, when 
included into a vaccine, increases the body’s immune response through engagement of TLR9 
within antigen presenting dendritic cells and B cells. TLR9-engaging adjuvants are known to 
generate Th1 cell- and cytokine-mediated immune responses (IFN-γ and IL-2) generated by Th1 
cells and IgG2a isotype antibodies and to vaccine antigens and pathogens. Generation of a 
Th1-biased humoral response may reduce risk associated with antibody-mediated disease 
enhancement based on FcγRII receptor affinity for Th1 antibodies versus Th2 antibodies [de Alwis 
2020; Fierz 2020]. 
2.2.4 
Data Supporting Development of TAP-COVID-19 Vaccine 
2.2.4.1 
Binding to CR3022 Monoclonal Antibodies 
Preliminary data indicates the RBD-Fc intact antigen binds to the human ACE-2 receptor and a 
SARS-CoV-2 RBD-specific, human neutralizing monoclonal antibody, CR3022. The data shows 
strong, dose-dependent binding of CR3022 to RBD-Fc antigen and RBD-Fc TAP vaccine. The 
RBD-Fc candidate antigens show >5X reactivity to CR3022 compared with commercially sourced 
control SARS spike and RBD reagents. These data suggest that the purified SARS-CoV-2 RBD-Fc 
antigen maintains essential conformational epitopes in a manner superior to commercially 
purchased reagents. 

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2.2.4.2 
Binding to ACE-2 Receptor 
Recombinant ACE-2 complexes containing RBD-Fc can be immunoprecipitated by ACE-2 
specific antisera in vitro. However, this does not provide a quantitative measure of binding. 
Quantitative and functional ACE-2 binding was performed using confocal microscopy and 
analysis by co-localization and competitive binding methods on Vero e6 cells in collaboration with 
scientists at the University of Louisville, Center for Predictive Medicine and Department of 
Microbiology & Immunology. The ability of the native agonist, angiotensin II, was compared with 
the RBD-Fc fusion or concentration dependent ability to block binding of an ACE-2 specific 
antibody to the receptor on living cells. Influenza H7 hemagglutinin was used as a control. 
FAM-angiotensin II bound to Vero e6 cells, with an average of a 2.79-fold increase over the 
non-specific H7 control. 
Binding of the RBD-Fc antigen to Vero e6 cells occurred in a concentration-dependent manner 
with an increase of 2.58-fold increase over the H7 control. Binding of H7 did not impact detection 
of ACE-2 by monoclonal antibody at any concentration. 
SARS-CoV-2 RBD-Fc fusion antigen shows functional conformation and activity through the 
binding by CR3022 and ACE-2. Binding to ACE-2 shows similar affinity and specificity as 
angiotensin II suggesting that the conformation of the spike protein RBD in the antigen-antibody 
complex is comparable to that observed with native SARS-CoV-2 spike protein. The data suggests 
that both antigen-antibody complexes display the correct structure necessary to elicit neutralizing 
antibodies to the RBD of SARS-CoV-2 spike protein. 
2.3 
Summary of Findings to Date 
KBP is also actively developing a quadrivalent seasonal influenza vaccine, TAP-V001, using the 
TAP platform. Nonclinical studies performed to support TAP-V001 are relevant and supportive of 
the TAP-COVID-19 program based on the quantities of the vaccine components. In particular, 
IND-enabling pharmacokinetic/biodistribution and GLP repeat dose toxicology studies have been 
completed using two different formulations of TAP-V001 vaccine that demonstrated: 
• No observed treatment-related or toxicologically significant clinical findings or inoculation 
site reactogenicity  
• No observed treatment-related or toxicologically significant effects for body weights, body 
weight changes, food consumption, body temperatures, ophthalmology, clinical chemistry, 
hematology, organ weights, and gross and microscopic pathology 
• Dose dependent TMV-specific RT-PCR signal measured at site of injection with rapid 
clearance from all non-target organs 
• Maintenance of TMV-specific RT-PCR signal in immune-processing organs, including 
lymph nodes and spleen 
• Efficacy in two ferret challenge studies, revealing statistically improved H1N1 clearance 
and statistically equivalent H3N2 clearance compared with Fluzone® control. 

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The same platform manufacturing process for production of TAP-V001 is used in the production 
of TAP-COVID-19, with the exception of the affinity chromatography resin, and a similar drug 
product formulation is employed. 
2.4 
Study Rationale 
Multiple vaccines have been approved for emergency use for the prevention of SARS-CoV-2, with 
other vaccines close to being available either through emergency use or licensed vaccines. 
Although work continues on antiviral treatments for SARS-CoV-2, given the crisis of COVID-19 
infections in the world, the fast expansion to the US and other parts of the world, and the global 
push to vaccinate everyone, additional sources of effective vaccine will be needed. 
2.5 
Dose Rationale 
As SARS-CoV-2 is a newly emergent respiratory viral disease, naïve subjects are expected to 
require a two dose (prime-boost) immunization regimen to generate a suitable immune response 
to offer protection from infection. The TAP-COVID-19 vaccine dose levels to be evaluated have 
been established using a prime-boost dosing strategy in mice as a model species to characterize 
the vaccine’s immunogenicity. Two doses of TAP-COVID-19 have demonstrated a robust and 
dose-dependent increase in the humoral antibody response to the vaccine in both total antibody 
and neutralizing antibody titers. This response was seen in separate KBP studies conducted at two 
different academic centers.  
The selected regimen is anticipated to be safe based on nonclinical toxicology studies conducted 
in rabbits which employed a 4-fold higher antigenic dose levels of a quadrivalent influenza vaccine 
candidate. There were no toxicologically relevant findings and it was determined that a property 
of TAP-based vaccines is the trafficking to immune organs (draining lymph nodes and spleen) 
which may serve as a mechanism for driving the immune response.  
Lastly, the proposed rationale for dose level and the dosing regimen is based on historical 
experience with other pandemic respiratory viral diseases including influenza and prior 
coronavirus outbreaks and is also consistent with other ongoing SARS-CoV-2 clinical studies. 

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3 
OBJECTIVES AND ENDPOINTS 
3.1 
Objectives 
3.1.1 
Primary Objective 
To assess the safety and reactogenicity of two doses of TAP-COVID-19 vaccine with CpG 
adjuvant for 7 days post vaccination compared with placebo as determined by solicited local and 
systemic reactogenicity 
3.1.2 
Secondary Objectives 
To compare the frequency of unsolicited AEs of each dose of TAP-COVID-19 vaccine with CpG 
adjuvant through Day 43 and SAEs, MAAEs, NOCDs, and AESIs through Day 365  
Comparisons include: 
• High dose (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG) to placebo 
• Low dose (15 μg TAP-COVID-19 vaccine + 0.5 mg CpG) to placebo 
• High dose (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG) to low dose 
(15 μg TAP-COVID-19 vaccine + 0.5 mg CpG) 
To evaluate the immunogenicity of TAP-COVID-19 vaccine with CpG adjuvant compared with 
placebo in terms of antibody assessed by GMTs of both spike RBD IgG and IgM antibodies and 
neutralizing antibody response, GMFR in neutralizing titer from baseline in all treatment groups 
at Days 8, 22, 29, 43, 90, 181, 273, and 365 relative to baseline 
3.1.3 
Exploratory Objectives 
To assess cellular immunity by measuring the numbers of cytokine producing CD4+ and CD8+ 
T-cells from PBMCs response to vaccine in all treatment groups at Days 8, 22, 29, 43, 90, 181, 
273, and 365 compared to baseline  
To assess the immunogenicity of the RBD and Fc component of the vaccine 
3.2 
Endpoints 
3.2.1 
Primary Endpoints 
Occurrence of Solicited AEs: 
• Solicited administration site reactions (eg, pain, tenderness, erythema/redness, 
induration/swelling) during the 7-day follow-up period after each vaccination (Day 1-8 and 
Day 22-29) 
• Solicited systemic events (eg, fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia) 
during the 7-day follow-up period after each vaccination (Day 1-8 and Day 22-29) 

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3.2.2 
Secondary Endpoints 
Safety: 
• Unsolicited AEs, MAAEs, and AESIs up to Day 43  
• SAEs, MAAEs, NOCDs, and AESIs up to Day 365 (approximately 1 year after first 
vaccination) 
Immunogenicity: 
• Vaccine ELISA of both RBD IgG and IgM antibodies and neutralizing antibody titers for 
each treatment group: 
o GMT at baseline and Days 15, 22, 43, 90, 181, 273, and 365 
o GMT ratio (GMTplacebo/GMTTAP-COVID-19) at baseline and Days 22, 29, 43, 90, 181, 
273, and 365 
o GMFR at Days 8, 22, 29, 43, 90, 181, 273, and 365 relative to baseline 
o Seroconversion rates on Days 8, 15, 22, 29, 43, 90, 181, 273, and 365. Seroconversion 
is defined as the proportion of subjects at the respective time point that have 
detectable antibodies (IgG and IgM) against SARS-CoV-2 Spike Protein RBD 
following challenge with vaccine (and potentially by natural asymptomatic or 
symptomatic infection by the virus in case of a placebo subject). 
o GMI on Days 8, 22, 29, 43, 90, 181, 273, and 365 
3.2.3 
Exploratory Endpoints 
Cellular immunity: 
• The number of cytokine producing CD4+ and CD8+ T-cells from PBMCs responsive to 
vaccine antigens in all treatment groups on Days 8, 22, 29, 43, 90, 181, 273, and 365 
compared to baseline  
Immunogenicity: 
⁃ 
Anti-RBD and anti-Fc antibodies at baseline and Days 8, 15, 22, 29, 43, 90, 181, 273, and 
365 

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4 
STUDY DESIGN 
4.1 
Study Design and Overview 
This is an FIH, observer-blinded, randomized, placebo-controlled, parallel group study to evaluate 
the safety and immunogenicity of TAP-COVID-19 vaccine with CpG adjuvant in healthy adult 
subjects in 2 age groups, Part A (18-49 years) and Part B (50-85 years). A study schematic is 
presented in Figure 4-1. 

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Figure 4-1 
Study Schematic for Parts A and B  
  
 
Abbreviations: High Dose = 45 μg TAP-COVID-19 vaccine + CpG (0.5 mg); iSRC = independent Safety Review Committee;  
Low Dose = 15 μg TAP-COVID-19 vaccine+ CpG (0.5 mg); Mtg = meeting 

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Part A and Part B: 
Subjects will be screened up to 14 days (Day -14 to Day -1) before randomization. Overall, 
approximately 90 eligible healthy adults ages 18-49 years (inclusive) will be enrolled for Part A 
and 90 eligible healthy adults ages 50-85 years will be enrolled for Part B.  
Sentinel dosing will be utilized in this FIH study. Sentinel cohorts will be used for the following 
groups:  
• Part A (18-49 years) low dose (15 μg TAP-COVID-19 vaccine + 0.5 mg CpG)  
• Part B (50-85 years) low dose (15 μg TAP-COVID-19 vaccine + 0.5 mg CpG)  
• Part A (18-49 years) high dose (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG)  
• Part B (50-85 years) high dose (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG)  
Three sentinel subjects from each part will be randomized 2:1 (active:placebo). The iSRC will 
review the safety data for the sentinel subjects through Day 8 prior to enrollment of the remaining 
cohort subjects randomized 2:1 (active:placebo). In the event that iSRC has not met for the post 
Day 8 review because the entire sentinel group (n = 3) has not completed Day 8 before a sentinel 
subject is to receive the second vaccine on Day 22, the iSRC will meet on an ad hoc basis, to 
ensure there are no safety concerns and that none of the Individual Discontinuation Criteria 
(Section 5.5) or Study Halting Rules (Section 5.7.2) have been met, prior to the sentinel subjects 
receiving the second vaccine. 
When all subjects in Part A (18-49 years) low dose have received the first vaccination and have 
all safety data through Day 8, the iSRC (Section 5.7.1) will convene and review the safety data to 
ensure that there are no safety concerns and that none of the Study Halting Rules have been met 
(Section 5.7.2) before recommending that the study enroll Part A high dose and Part B 
(50-85 years) low dose.  
When all subjects in Part B (50-85 years) low dose have received the first vaccination and have all 
safety data through Day 8, the iSRC will convene and review the safety data to ensure that there 
are no safety concerns and that none of the Study Halting Rules have been met before 
recommending that the study enroll Part B high dose. 
The iSRC will convene and review the safety data when a minimum of 23 subjects have completed 
Day 29 after the second vaccination for Part A (low and high dose) and for Part B (low and high 
dose) to ensure that there are no concerns. 
Both Part A (18-49 years) and Part B (50-85 years) will be randomized in a 2:1 ratio 
(active:placebo) for each treatment dose (15 μg and 45 μg TAP-COVID-19 vaccine + 0.5 mg CpG) 
for a total of 90 subjects per Part (30 subjects 15 μg TAP-COVID-19 vaccine + 0.5 mg 
CpG:30 subjects 45 μg TAP-COVID-19 vaccine + 0.5 mg CpG:30 subjects placebo). 
Treatment A: TAP-COVID-19 vaccine (15 μg) + CpG (0.5 mg) IM injection on 
Day 1 and Day 22 (±3 days) 

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Treatment B: TAP-COVID-19 vaccine (45 μg) + CpG (0.5 mg) IM injection on 
Day 1 and Day 22 (±3 days) 
Treatment C: Placebo (buffered saline solution) IM injection on Day 1 and Day 22 
(±3 days) 
Study vaccine will be prepared by an unblinded site pharmacist and administered at the clinical 
research site on Day 1 and Day 22 (±3 days) by unblinded CRU personnel. Subjects will be 
observed for immediate AEs and/or reactogenicity for approximately 60 minutes after 
administration of vaccine. Subjects will be provided with a Diary Card and will be trained to record 
specifically elicited systemic and local symptoms daily as well as any additional AEs during the 
7-day follow-up period after each vaccination. Visits will be conducted at the clinical site on an 
outpatient basis or as a telephone visit per the Schedule of Assessments and Procedures 
(Table 1-1). Subjects will participate in the study for approximately 1 year from the first dose. 
AEs and concomitant medications will be captured through Day 43. Blood and serum samples for 
safety laboratory tests, RBD IgG and IgM antibodies, and neutralizing antibody titers, cell-
mediated immunity, and other future biomedical research will be obtained at baseline and before 
administration of vaccine dose 2 and after each vaccination per the Schedule of Assessments and 
Procedures (Table 1-1). SAEs, MAAEs, NOCDs, and AESIs only will be captured after Day 43 to 
study completion (Day 365 [approximately 1 year after vaccination]). 
Prior to receiving a second dose of vaccine, subjects will have the following assessments 
performed to ensure eligibility: vital signs (including temperature), review of clinical laboratory 
test results to date, nasopharyngeal swab Day 15 to check for SARS-CoV-2 infection (RT-PCR 
result must be received by the CRU and negative prior to the second vaccine administration), 
medical history since last visit including AE assessment for SAEs, Grade 3 AEs, or AESIs that are 
possibly, probably, or definitely related to study vaccine without a plausible alternative 
explanation, targeted physical examination, recheck of eligibility criteria, and pregnancy test (as 
applicable). 
Subjects will be monitored for SARS-CoV-2 exposure for potential asymptomatic infection 
throughout the study.  
• If a subject has a positive or borderline ELISA anti-N IgG result, sites should have the 
subject return for an unscheduled PCR. If the ELISA is positive and the PCR is negative, 
the sites should follow the subjects using the standard of care under Investigator discretion, 
retesting ELISA at the next study visit(s) or sooner (per the Investigator’s decision). 
• If the subject has a positive or borderline ELISA anti-N IgG AND a positive PCR test, the 
clinical sites should bring the subjects back for repeat PCR testing as described below. 
• The clinical sites should continue to collect PCR tests if a subject is experiencing possible 
COVID-19 symptoms, or had possible exposure to SARS-CoV-2 (ie, close contact tests 
positive for SARS-CoV-2). Testing will occur every 2 weeks for a total of 4 weeks (if 
2 consecutive negative tests) or until negative (x2) after a positive result. Positive results 

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will be reported as an AESI (Section 8.2.2) and subjects followed for disease severity, 
duration, and outcome. 
Subjects who are seropositive for SARS-CoV-2 and asymptomatic will be allowed to enroll into 
Parts A and B of the study as long as the subject is RT-PCR negative. 
Additional details for the ELISA test results are presented in Appendix C. 
Part C Expansion (Optional): 
The Part C Expansion may be conducted to confirm the safety and immunogenicity of a selected 
dose across the broad target age span using a larger sample size. The proposed sample size was 
selected based on WHO guidelines on clinical evaluation of vaccines: regulatory expectations 
Annex I (2001), which states that approximately 300 subjects are needed to identify common local 
reactogenicity events. A larger sample size will assist in a better characterization of kinetics and 
range of immunity (neutralizing antibody titers) and provide a more reliable output of 
seropositivity and seroconversion to TAP-COVID-19 immunization. With the limited clinical 
experience with SARS-CoV-2 vaccines and the current lack of a biomarker correlate of protection, 
the generation of this larger data set is relevant to inform the design and implementation of a Phase 
3 program. After review of safety and immunogenicity data from Parts A and B through Day 43, 
a dose for the Phase II expansion study will be recommended by the iSRC. Progression to Part C 
will only take place after CBER has had the opportunity to review the human clinical plus 
additional nonclinical data and concurs with the plan to proceed with enrollment. Subjects 
≥18 years of age will be enrolled and randomized 1:1 (selected active dose:placebo). Up to 
1000 subjects will be enrolled at the chosen dose to provide expanded dose confirmation, safety, 
and immunogenicity data. Although all subjects in Part C will have safety laboratory tests 
performed at screening, only the first 200 subjects in Part C will have safety laboratory tests 
performed at all post-dose time points. The remaining subjects in Part C will not have safety 
laboratory tests performed at any of the post-dose time points unless the Investigator deems it 
necessary. 
Subjects who are seropositive for SARS-CoV-2 and asymptomatic will be allowed to enroll into 
Part C of the study. 
4.1.1 
Duration of Study 
Each subject will receive two doses of study vaccine or placebo, the first on Day 1 and the second 
on Day 22 (±3 days). The total duration of subject participation is approximately 1 year (including 
screening, treatment, and follow-up periods).  
4.1.2 
Interim Safety Data Review 
For all of the sentinel groups, the iSRC will meet to review the sentinel subjects’ safety and 
tolerability data through Day 8. In the event that iSRC has not met for the post Day 8 review 
because the entire sentinel group (n = 3) has not completed Day 8 before a sentinel subject is to 
receive the second vaccine on Day 22, the iSRC will meet on an ad hoc basis, to ensure there are 
no safety concerns and that none of the Individual Discontinuation Criteria (Section 5.5) or Study 

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Halting Rules (Section 5.7.2) have been met, prior to the sentinel subjects receiving the second 
vaccine. 
When all subjects in Part A (18-49 years) low dose have received the first vaccination and have 
all safety data through Day 8, the iSRC (Section 5.7.1) will convene and review the safety data to 
ensure that there are no safety concerns and that none of the Study Halting Rules have been met 
(Section 5.7.2) before recommending that the study enroll Part A high dose and Part B low dose. 
The same strategy will be used for Part B when going from low to high dose.  
The iSRC will be asked to review unblinded immunogenicity and safety data when the first 
30 subjects vaccinated in the Part A low dose group (including active and placebo subjects) have 
data available from Day 1 through Day 43 for an assessment of the risk-benefit of the trial. For the 
interim analysis, treatment codes will be unblinded and only after the data are deemed ready for 
the analysis and the data has been monitored. The unblinded review will be completed by the iSRC 
only and the other team members (CRO [except for the unblinded team members preparing the 
data for unblinded iSRC review], Investigator, and site personnel) will remain blinded until 
completion of the study. The Sponsor will be unblinded at the interim analysis. 
The iSRC will also meet when a minimum of 23 subjects have completed Day 29 after the second 
vaccination for Part A (low and high dose) and for Part B (low and high dose) to review safety 
data to ensure that there are no concerns. 
The iSRC will also review all data through Day 43 for Part A and for Part B in both dose groups 
to monitor for ongoing safety concerns and immunogenicity analysis. When the Parts A and B 
Day 43 (low and high dose) review is complete, the iSRC will recommend a dose for the Part C 
Expansion (optional). Progression to Part C will only take place after CBER has had the 
opportunity to review the Day 43 data from Parts A and B and concurs with the plan to proceed 
with enrollment. 
4.1.3 
Definition of Study Completion 
End-of-study procedures will be performed as specified in the Schedule of Assessments and 
Procedures (Table 1-1); subjects who withdraw from the study early will have EOS procedures 
performed at the time of discontinuation. If a subject refuses to return for the EOS blood samples, 
the safety follow-up will be completed via telephone. Subjects with ongoing clinically significant 
clinical or laboratory findings will be followed until the finding is resolved or medically stable; 
reasonable attempts will be made to follow-up with subjects. The subject’s participation in the 
study will end once all study assessments and follow-up have been completed. 
4.1.4 
End of Study 
The end of the study is defined as the date when the last subject has completed all study procedures 
up to and including the EOS/early termination visit as specified in the Schedule of Assessments 
and Procedures (Table 1-1). 

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5 
SELECTION AND WITHDRAWAL OF SUBJECTS 
5.1 
Inclusion Criteria 
Subjects must meet all inclusion criteria to be eligible for study participation. In addition, racial 
and ethnic minorities will be sought to obtain a diverse study population. 
All Subjects 
1. Subject read, understood, and signed the ICF.  
2. Healthy adult males and females 18-49 years of age (Part A) or 50-85 years of age (Part B), 
inclusive, at screening. 
3. RT-PCR negative at time of screening.  
4. BMI of ≥ 18 and ≤ 30 kg/m2 (National Heart, Lung, and Blood Institute) at screening. 
BMI = weight (kg)/(height [m])2. 
5. Must be in general good health before study participation with no clinically relevant 
abnormalities that could interfere with study assessments. 
6. WOCBP and men whose sexual partners are WOCBP must be able and willing to use at least 
1 highly effective method of contraception (ie, include hysterectomy, bilateral salpingectomy, 
and bilateral oophorectomy, hormonal oral [in combination with male condoms with 
spermicide], transdermal, implant, or injection, barrier [ie, condom, diaphragm with 
spermicide]; intrauterine device; vasectomized partner [6 months minimum], clinically sterile 
partner; or abstinence) during the study.  
• 
A female subject is considered to be a WOCBP after menarche and until she is in a 
postmenopausal state for 12 consecutive months (without an alternative medical cause) or 
otherwise permanently sterile.  
• 
Note: Subjects not of childbearing potential are not required to use any other forms of 
contraception during the study. Non-childbearing potential is defined as subject 
confirmed:  
o Surgical sterilization (eg, bilateral oophorectomy, bilateral salpingectomy, bilateral 
occlusion by cautery [Essure System is not acceptable], hysterectomy, or tubal ligation)  
o Postmenopausal (defined as permanent cessation of menstruation for at least 
12 consecutive months prior to screening) with FSH ≥ 30 mIU/mL at screening 
7. WOCBP must have a negative urine pregnancy test before each vaccination. 
8. Must be able to attend all visits, including unscheduled visits if respiratory symptoms 
suggestive of SARS-CoV-2 infection develop during the study, for the duration of the study 
and comply with all study procedures, including daily completion of the Diary Card for 7 days 
after each injection. 

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5.2 
Exclusion Criteria 
Subjects will not be eligible for study participation if they meet any of the exclusion criteria, or 
will be discontinued at the discretion of the Investigator if they develop any of the exclusion criteria 
during the study. 
Parts A and B 
1. History of an acute or chronic medical condition including dementia that, in the opinion of the 
Investigator, would render vaccination unsafe or would interfere with the evaluation of 
responses. Chronic conditions that are NOT included on the CDC’s list of subjects at higher 
risk for severe illness from SARS-CoV-2 (CDC COVID-19 website) are acceptable if the 
condition has been stable for the 3 months prior to vaccine administration (Day 1), with no 
medication changes, and no hospitalization in the past 6 months. 
2. History of any medical conditions that place subjects at higher risk for severe illness due to 
SARS-CoV-2 including but not limited to cancer, chronic kidney disease at any stage, chronic 
lung disease, dementia or other neurological conditions, diabetes (Type 1 or Type 2), Down 
syndrome, heart conditions, HIV infection, immunocompromised state (weakened immune 
system), liver disease, overweight/obesity, pregnancy, sickle cell disease or thalassemia, 
smoker (current or former), transplants (solid organ or blood stem cell), stroke or 
cerebrovascular disease, and substance use disorders. (See the latest updates at the CDC 
COVID-19 website.) 
3. History of ongoing clinical condition or medication or treatments that may adversely affect the 
immune system. 
4. Individuals who are RT-PCR positive for SARS-CoV-2 at screening or prior to second dose 
of TAP-COVID-19 vaccine.  
5. Individuals who are at increased risk of exposure to SARS-CoV-2 (eg, healthcare workers, 
emergency responders).  
6. Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine 
administration.  
7. Living in a group care facility (eg, assisted living or nursing home). 
8. Individuals with any elevated (Grade 1 or higher) laboratory test assessed as clinically 
significant for age by the Investigator at screening (Guidance for Industry: Toxicity Grading 
Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical 
Trials (September 2007), Tables for Laboratory Abnormalities). 
9. Individuals with elevated (Grade 1 or higher) liver function enzyme at screening, may repeat 
testing once to re-assess clinical significance. If the retest comes back within normal range, the 
subject will be eligible for enrollment with Investigator and Medical Monitor approval. See 
below for the criteria for excluding subjects with elevated liver enzymes (once confirmed by 
retest): 
• 
ALP, ALT, AST, or GGT >1.5 × ULN 
• 
Total bilirubin >1.6 × ULN 

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10. Active neoplastic disease (excluding nonmelanoma skin cancer that was successfully treated) 
or a history of any hematological malignancy. “Active” is defined as having received treatment 
within the past 5 years. 
11. Long-term (greater than 2 weeks) use of oral or parenteral steroids, high-dose inhaled steroids 
(>800 μg/day of beclomethasone dipropionate or equivalent), or immunomodulatory drugs 
within 6 months before screening (nasal and topical steroids are allowed). 
12. History of autoimmune, inflammatory disease, or potential immune-mediated medical 
conditions (Appendix B). 
13. Women currently pregnant, lactating, or planning a pregnancy between enrollment and 
181 days after randomization. 
14. History of Guillain-Barré Syndrome.  
15. History of anaphylactic-type reaction to injected vaccines.  
16. Known or suspected hypersensitivity to 1 or more of the components of the vaccine, including 
thimerosal, tobacco, and CpG adjuvant.  
17. History of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of 
drug abuse or addiction within 12 months of screening. 
Note: In those regions where cannabis use is legal, it will be left to the discretion of the 
Investigator to decide if a subject is an occasional user or an abuser of cannabis. The 
Investigator should discuss user/abuser status on a case-by-case basis with the Medical 
Monitor prior to enrollment. 
18. Acute illness or fever within 3 days before study enrollment (enrollment may be delayed for 
full recovery if acceptable to the Investigator).  
19. Individuals currently participating or planning to participate in a study that involves an 
experimental agent (vaccine, drug, biologic, device, or medication); or who have received an 
experimental agent within 1 month (3 months for immunoglobulins) before enrollment in this 
study; or who expect to receive another experimental agent during participation in this study. 
20. Receipt of immunoglobulin or another blood product within the 3 months before enrollment in 
this study or those who expect to receive immunoglobulin or another blood product during this 
study.  
21. Individuals who intend to donate blood within 6 months after the first vaccination.  
22. Individuals using prescription medications for prophylaxis of SARS-CoV-2.  
23. Individuals who plan to receive another vaccine within the first 3 months of the study except 
influenza vaccine which should not be given within 2 weeks of study vaccine.  
24. Receipt of any other approved SARS-CoV-2 vaccine prior to the first study vaccine or within 
90 days after administration of the first study vaccine.  
25. Receipt of any other experimental coronavirus vaccine at any time prior to or during the study.  
26. Receipt of any investigational vaccine or drug within 1 month of enrollment and through the 
end of the study (1 year after first vaccination). 

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27. Plan to travel outside the subjects’ country of residence from enrollment through Day 43.  
28. History of surgery or major trauma within 12 weeks of screening, or surgery planned during 
the study. 
29. Significant blood loss (>450 mL) or has donated 1 or more units of blood or plasma within 
6 weeks prior to study participation. 
30. Strenuous activity (as assessed by the Investigator) within 48 hours prior to dosing (Days 1 
and 22). 
31. A positive urine drug screen without evidence of corresponding prescribed concomitant 
medication(s) at Screening. Note: A positive drug screen result with a corresponding 
prescribed concomitant medication will be allowed if, in the opinion of the investigator and 
Medical Monitor, the concomitant medication does not make the subject unsuitable to 
participate in the clinical trial. For a positive tetrahydrocannabinol result, refer to Exclusion 
Criteria #17. 
32. Positive alcohol screen. 
33. Positive screen for HIV-1 and HIV-2 antibodies, HBsAg, or HCV antibody. 
34. Involved in the planning or conduct of this study. 
35. Unwilling or unlikely to comply with the requirements of the study. 
36. Subject is an employee, contractor, friend of or relative of any employee of Sponsor, CRO, 
study site or site affiliate. 
Part C 
If the study proceeds to the Part C Expansion study to confirm the safety and immunogenicity of 
the selected dose of vaccine, the following exclusion criteria (Number, from Parts A and B above) 
will be not applicable. 
(5) Individuals who are at increased risk of exposure to SARS-CoV-2 (eg, healthcare workers, 
emergency responders). 
(6) Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine 
administration. 
 
(7) Living in a group care facility (eg, assisted living or nursing home). 
(31) A positive urine drug screen without evidence of corresponding prescribed concomitant 
medication(s) at Screening. Note: A positive drug screen result with a corresponding 
prescribed concomitant medication will be allowed if, in the opinion of the investigator and 
Medical Monitor, the concomitant medication does not make the subject unsuitable to 
participate in the clinical trial. 
(32) Positive alcohol screen. 
(33) Positive screen for HIV-1 and HIV-2 antibodies, HBsAg, or HCV antibody (Parts A and B). 
For Part C, subjects known to be HIV positive or have active Hepatitis B or C infection will 
be excluded. 

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5.3 
Screen Failures 
Subjects who are discontinued from the study prior to study vaccine administration will be 
considered screen failures and may be re-screened as long as the subject was not discontinued from 
the study due to noncompliance with the protocol (eg, positive urine drugs of abuse screen, etc.). 
If the subject is re-screened, the subject must be re-consented and have all of the screening 
procedures re-performed. 
Screen failure data will not be recorded in the eCRF. 
5.4 
Decision to Administer Second Vaccination 
Prior to administering the second vaccination, subjects will have the following 
procedures/assessments performed: 
• Inclusion/exclusion criteria recheck (including absence of acute illness or new medical 
condition) 
• Oral temperature 
• Targeted physical examination  
• Vital signs 
• Review of clinical safety laboratory test results to date 
• Urine pregnancy test, as applicable 
• Nasopharyngeal swab on Day 15 to check for SARS-CoV-2 infection (result must be 
received by the CRU and negative prior to the second vaccine administration). 
• Medical history since last visit including AE assessment for SAEs, Grade 3 AEs or AESIs 
that are possibly, probably, or definitely related to study vaccine without a plausible 
alternative explanation 
• Check of Study Halting Rules (Section 5.7.2) 
All assessments must be normal or be in agreement with inclusion/exclusion criteria in order for a 
subject to receive the second vaccination dose.  
For all of the sentinel groups, the iSRC will meet to review the sentinel subjects’ safety and 
tolerability data through Day 8. In the event that iSRC has not met for the post Day 8 review 
because the entire sentinel group (n = 3) has not completed Day 8 before a sentinel subject is to 
receive the second vaccine on Day 22, the iSRC will meet on an ad hoc basis, to ensure there are 
no safety concerns and that none of the Individual Discontinuation Criteria (Section 5.5) or Study 
Halting Rules (Section 5.7.2) have been met, prior to the sentinel subjects receiving the second 
vaccine. 

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5.5 
Individual Discontinuation Criteria 
The occurrence of the following findings in an individual subject may result in discontinuation 
from the study vaccine. Subjects will be asked to participate in the scheduled Follow-up Visits, 
including at a minimum Day 365, to check safety and immunogenicity. 
• Subjects experiences an SAE assessed as possibly related, probably related, or related to 
study vaccine without a plausible alternative explanation. 
• Subject has generalized urticaria during the 7-day post vaccination period. 
• Subject develops a Grade 4 local reaction for which there is no alternative plausible 
explanation.  
• Subject experiences laryngospasm, bronchospasm, or anaphylaxis after vaccine 
administration considered related to the vaccine.  
• Subject develops a fever >40°C/104°F during the 7 days post vaccination period that is 
assessed as possibly related, probably related, or related to study vaccine without a 
plausible alternative explanation. 
• Single Grade 3 AEs or AESIs that are possibly, probably, or definitely related to study 
vaccine without a plausible alternative explanation. 
• Subject experiences any Grade 3 or higher abnormality in the same laboratory parameter 
determined by the Investigator or medical monitor as clinically significant and that are 
assessed as possibly related, probably related, or related to study vaccine without a 
plausible alternative explanation.  
5.6 
Subject Withdrawal 
Subjects are free to withdraw from the study at any time, for any reason, and without prejudice to 
further treatment. The Investigator may withdraw a subject if, in the Investigator’s judgment, 
continued participation would pose unacceptable risk to the subject or to the integrity of the study 
data. All procedures for early withdrawal must be completed. Reasons for withdrawal may include: 
• AE 
• SAE that is possibly related, probably related, or related, without a plausible alternative 
explanation 
• Lost to follow-up 
• Physician decision 
• Pregnancy 
• Protocol deviation 
• Study terminated by Sponsor 
• Withdrawal by subject 
• Death 
• Other 

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Subjects who are withdrawn for reasons other than AEs may be replaced. 
In the event of a subject’s withdrawal from study vaccine, the Investigator will promptly notify 
the Sponsor and will make every effort to complete the EOS assessments, unless the subject 
withdraws consent. All withdrawn subjects with ongoing clinically significant clinical or 
laboratory findings will be followed until the finding is resolved or medically stable; reasonable 
attempts will be made to follow-up with subjects. The subject will also be asked to participate in 
a Follow-up Visit at approximately Day 365 to check safety and immunogenicity.  
Subjects may be withdrawn from receiving the second dose of the study vaccine if they meet 
specific Study Halting Rules (see Section 5.7.2) or Individual Discontinuation Criteria 
(Section 5.5). If a subject is withdrawn due to meeting a Study Halting Rule or Individual 
Discontinuation Criteria, they will be asked to participate in the scheduled Follow-up Visits, 
including at a minimum Day 365, to check safety and immunogenicity.  
5.7 
Independent Safety Review Committee, Study Stopping Rules, and Study 
Termination 
5.7.1 
Independent Safety Review Committee 
A safety review will be performed by the iSRC according to details established at the start of the 
study and provided in the iSRC charter. The Investigator will provide a brief summary to the iSRC 
of any pertinent safety events prior to the iSRC meeting. The three member iSRC will consist of, 
at a minimum, two physicians with experience in vaccines and one statistician.  
The iSRC will review the safety and tolerability data through Day 8 for each of the sentinel subject 
groups prior to the enrollment of the remaining cohort subjects. In the event that iSRC has not met 
for the post Day 8 review because the entire sentinel group (n = 3) has not completed Day 8 before 
a sentinel subject is to receive the second vaccine on Day 22, the iSRC will meet on an ad hoc 
basis, to ensure there are no safety concerns and that none of the Individual Discontinuation 
Criteria (Section 5.5) or Study Halting Rules (Section 5.7.2) have been met, prior to the sentinel 
subjects receiving the second vaccine. 
The iSRC will be convened to review all available safety data including solicited AEs, unsolicited 
AEs, SAEs, MAAEs, NOCDs, AESIs, vitals, safety laboratory, and physical exams results of 
Part A low dose when all subjects have received the first vaccination and have all safety data 
through Day 8. If there are no safety concerns after the iSRC meeting, study enrollment will 
continue to Part A high dose and Part B low dose. The same strategy will be used to move from 
Part B low dose to Part B high dose.  
The iSRC will also meet when a minimum of 23 subjects have completed Day 29 after the second 
vaccination for Part A (high and low dose) and for Part B (high and low dose) to review safety 
data to ensure that there are no concerns. 
The iSRC will be asked to review unblinded immunogenicity and safety data when the first 
30 subjects vaccinated in the Part A low dose group (including active and placebo subjects) have 
data available from Day 1 through Day 43 for an assessment of the risk-benefit of the trial. For the 

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interim analysis, treatment codes will only be unblinded by treatment group (not by individual 
subjects) and only after the data are deemed ready for the analysis and the data has been monitored. 
The unblinded review will be completed by the iSRC only and the other team members (CRO 
[except for the unblinded team members preparing the data for unblinded iSRC review], 
Investigator, and site personnel) will remain blinded. The Sponsor will be unblinded at the interim 
analysis (Day 43). The iSRC/Sponsor will communicate immunogenicity data to the study team 
in a blinded manner so that clinical development decisions for additional studies can be made by 
the Sponsor.  
Cohort dose continuation/escalation will only occur if the iSRC determines that the current dose 
was safe and well tolerated. If justified by cumulative safety and tolerability data, the iSRC can 
dose escalate per protocol, select an intermediate dose (lower or higher), or repeat a dose. The 
decision to allow dose continuation/escalation into the next cohort will be documented and this 
decision, along with the safety information, will be communicated to the site. 
The iSRC will also meet on an ad hoc basis if any of the Study Halting Rules are met 
(Section 5.7.2). If a Study Halting Rule is met, the iSRC will proceed with an unblinded review of 
available safety data. After the meeting, the iSRC will make 1 or more of the following 
recommendations: 
• All vaccinations should resume 
• Specific treatment groups should be discontinued while other treatment groups should 
resume vaccinations 
• No vaccinations should resume  
• Modifications to study conduct (eg, additional safety or laboratory assessments) 
The blinded medical monitor will also assess cumulative safety information for this study per the 
Medical Monitoring Plan and advise the Sponsor of any of the safety findings (Section 5.7.2) have 
occurred.  
The iSRC will review unblinded safety data for any subject who dies, requires ICU admission due 
to SARS-CoV-2 infection, develops an AESI (Section 8.2.2) of autoimmune disease or potential 
immune-medicated medical condition (Appendix B), or experiences vaccine-associated enhanced 
respiratory disease. If the subject had received TAP-COVID-19, the iSRC may decide whether a 
study halt for vaccine-enhanced disease is required based on a review of all available clinical and 
preclinical safety and immunogenicity data. 
5.7.2 
Study Halting Rules 
The occurrence and confirmation of 1 or more of the following findings will result in suspension 
of further enrollment and study vaccine administration pending urgent review (within 1 week) of 
the safety data by the iSRC. Subjects who are withdrawn from study vaccine (if applicable) will 
continue to be monitored (Section 5.6) for safety and immunogenicity. 
1. One or more subjects experience an SAE assessed as possibly related, probably related, or 
related to study vaccine without a plausible alternative explanation. 

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2. One or more subjects have generalized urticaria during the 7-day post vaccination period. 
3. One or more subjects develop a Grade 4 local reaction for which there is no alternative 
plausible explanation.  
4. One or more subjects experiences laryngospasm, bronchospasm, or anaphylaxis after 
vaccine administration considered related to the vaccine.  
5. One or more subjects develop a fever >40°C/104°F during the 7 days post vaccination 
period that is assessed as possibly related, probably related, or related to study vaccine 
without a plausible alternative explanation. 
6. Two or more subjects within an individual treatment group, or 2 or more subjects across 
treatment groups, experience any Grade 3 or higher abnormality in the same laboratory 
parameter determined by the Investigator or medical monitor as clinically significant and 
that are assessed as possibly related, probably related, or related to study vaccine without 
a plausible alternative explanation.  
Note: An unblinded statistician or designee will assist with determining whether stopping 
rule #6 is met. 
7. Two or more subjects across treatment groups experience a Grade 3 or higher AE, MAAE, 
or AESI of the same or similar preferred terms (as categorized by MedDRA) assessed as 
possibly related, probably related, or related to study vaccine without a plausible alternative 
explanation. 
8. Any subject with severe SARS-CoV-2 infection will be assessed for the possibility of 
vaccine-associated enhanced respiratory disease. Severe SARS-CoV-2 infection is defined 
as individuals who have virologically confirmed SARS-CoV-2 infection with any of the 
following: 
• Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30 breaths 
per minute, heart rate ≥ 125 bpm, SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 
< 300 mmHg) 
• Respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, 
mechanical ventilation or ECMO) 
• Evidence of shock (systolic blood pressure < 90 mmHg, diastolic blood pressure 
< 60 mmHg, or requiring vasopressors) 
• Significant acute renal, hepatic, or neurologic dysfunction 
• Admission to an ICU 
• Death due to SARS-CoV-2 infection 
5.7.3 
Study Termination 
The study may be terminated at any time by the Sponsor if serious side effects occur, if potential 
risks to study participants are identified, if the Investigator does not adhere to the protocol, or if, 
in the Sponsor’s judgment, there are no further benefits to be achieved from the study. In the event 

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that the clinical development of the study vaccine is discontinued, the Sponsor shall inform all 
Investigators/institutions and regulatory authorities. 

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6 
TREATMENT OF SUBJECTS 
6.1 
Identity of Study Vaccines 
The TAP-COVID-19 vaccine is comprised of a purified recombinant SARS-CoV-2 RBD-Fc 
conjugated to a TMV NtK carrier. The TAP-COVID-19 vaccine will be combined with CpG 7909 
adjuvant prior to administration. 
The product will be formulated and shipped as multi-dose vials. The vaccine doses will be diluted 
as appropriate by the site pharmacist to 15 μg or 45 μg doses of antigen along with 0.5 mg CpG 
adjuvant to be delivered in a single 0.5 mL IM injection. A detailed description for vaccine 
preparation is provided in the pharmacy manual. 
Buffered saline solution (with thimerosal) will be used as placebo. 
A description of the study vaccines is presented in Table 6-1. 
Table 6-1 
Study Vaccines 
Study Vaccine 
Dosage Form  
(Volume, Route) 
TAP-COVID-19 
Dose 
Manufacturer 
TAP-COVID-19 + CpG (0.5 mg) 
Injectable solution, (0.5 mL, 
intramuscular injection) 
15 μg 
Kentucky 
BioProcessing, Inc. 
TAP-COVID-19 + CpG (0.5 mg) 
Injectable solution, (0.5 mL, 
intramuscular injection) 
45 μg 
Kentucky 
BioProcessing, Inc. 
Placebo (buffered saline solution) 
Injectable solution, (0.5 mL, 
intramuscular injection) 
Not  
applicable 
Kentucky 
BioProcessing, Inc. 
TAP-COVID-19, CpG adjuvant, and the placebo (buffered saline solution) will be sourced by KBP.  
6.2 
Treatments Administered 
Both Part A (18-49 years) and Part B (50-85 years) will be randomized in a 2:1 ratio 
(active:placebo) for each treatment dose (15 μg and 45 μg TAP-COVID-19 vaccine + 0.5 mg CpG) 
for a total of 90 subjects per Part (30 subjects 15 μg TAP-COVID-19 vaccine + 0.5 mg CpG:30 
subjects 45 μg TAP-COVID-19 vaccine + 0.5 mg CpG:30 subjects placebo). 
Treatment A: TAP-COVID-19 vaccine (15 μg) + CpG (0.5 mg) IM injection on 
Day 1 and Day 22 (±3 days) 
Treatment B: TAP-COVID-19 vaccine (45 μg) + CpG (0.5 mg) IM injection on 
Day 1 and Day 22 (±3 days) 
Treatment C: Placebo (buffered saline solution) IM injection on Day 1 and Day 22 
(±3 days) 
The IM dose for Part C Expansion (optional) will be determined after reviewing the safety and 
immunogenicity data through Day 43 from Parts A and B (low and high dose).  

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6.3 
Method of Assigning Subjects to Treatment Groups 
ICON will prepare the randomization scheme in accordance with its SOPs and the randomization 
plan, which reflect GCP standards. Refer to Section 9.3 for a description of randomization 
methods. Eligible subjects will be assigned to a treatment group according to the list of subject 
randomization assignments. 
6.4 
Measurements of Treatment Compliance 
All study vaccine doses will be prepared and administered by delegated and trained staff at the 
clinical site(s). Details regarding dosing, including the dose administered and the date and time of 
dosing, will be recorded. 
6.5 
Study Vaccine Storage, Accountability, and Retention 
6.5.1 
Storage Conditions 
The Investigator will ensure that all the study vaccines are stored per the instructions 
accompanying the study vaccine. In addition, the Investigator will ensure that study vaccines are 
handled in accordance with the FDA regulations concerning the storage and administration of 
investigational products. 
Refer to the SRM for additional study vaccine storage instructions. 
6.5.2 
Drug Accountability and Retention 
The Investigator must ensure that all study vaccine supplies are kept in a secure locked area with 
access limited to those authorized by the Investigator. The Investigator must maintain accurate 
records of the receipt of all study vaccine shipped by KBP or their representative, including but 
not limited to the date received, lot number, expiration date, amount received, and the disposition 
of all study vaccine. Current dispensing records will also be maintained including the date and 
amount of study vaccine dispensed and the subject receiving the drug. All remaining study vaccine 
not required by regulations to be held by the clinical site(s) must be returned to KBP or their 
representative immediately after the study is completed. 
6.6 
Packaging and Labeling 
6.6.1 
Study Vaccine 
Study vaccine will be supplied as a concentrated injectable solution packaged in 10-mL multi-dose 
vials with preservative (thimerosal). CpG sterile solution will be supplied as a concentrated 
solution with preservative (thimerosal). Placebo will be buffered saline solution with preservative 
(thimerosal) provided by KBP.  

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6.6.2 
Blinding of Treatment Assignment 
ICON will maintain the randomization code in a secure location with controls to prevent 
unauthorized access, including the computer program written to generate the randomization, 
randomization codes, program log, seed number used by the program, copy of the randomization 
plan along with approval documentation as appropriate, and the write-protected electronic storage 
medium. 
The site and CRO will name an unblinded statistician to provide the randomization code. The 
pharmacists will be unblinded. Since the placebo and vaccine will not be identical in appearance, 
the staff member administering the doses will be unblinded and will not participate in any 
additional study activities. In order to preserve the blind, study vaccine will be prepared and 
administered in a manner that masks the content for both the subject and any observers. 
Investigators, site staff, subjects, CRO [except for the unblinded team members preparing the data 
for unblinded iSRC review] will remain blinded until the completion of the study. The Sponsor 
will remain blinded to individual subjects’ treatment assignment from the beginning of the study 
through Day 43. When the data is unblinded for the interim analysis after all subjects complete 
Day 43, the Sponsor will be unblinded.  
6.6.3 
Unblinding of Treatment Assignment 
6.6.3.1 
Unblinding for Adverse Event/Safety Reasons 
Should an SAE or other circumstance require that the blind be broken to ensure subject safety, the 
Investigator must immediately notify the medical monitor and/or Sponsor. ICON/designee will 
notify the Sponsor as soon as possible and will release the treatment assignment of the subject to 
the appropriate personnel in accordance with the applicable SSP. 
If the treatment assignment is unblinded by the site pharmacist or any party other than ICON, the 
Investigator must notify ICON in writing and document the course of events in the source records. 
Any subject for whom the treatment code is prematurely released will be withdrawn from the 
study. 
6.6.3.2 
Unblinding for Interim Analyses 
An unblinded interim analysis will be performed on the safety and immunogenicity data collected 
for each of the 4 dose groups (Part A low dose, Part A high dose, Part B low dose, and Part B high 
dose). Unblinded interim analysis will occur for the Part A low dose group (including active and 
placebo subjects) when the first 30 subjects vaccinated have data available from Day 1 through 
Day 43. The remaining cohorts will have an unblinded interim analysis performed when all 
subjects in the cohort have data from Day 1 through Day 43. For the interim analysis, treatment 
codes will be unblinded after the data are deemed ready for the analysis and the data has been 
monitored The CRO [except for the unblinded team members preparing the data for unblinded 
iSRC review], Investigator, and clinical staff will not have access to the unblinded treatment group 
interim analyses and will remain blinded until completion of the study. The Sponsor will be 
unblinded at the interim analysis. The iSRC will communicate immunogenicity data to the study 

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team in a blinded manner so that clinical development decisions for additional studies can be made 
by the Sponsor. 
6.7 
Concomitant Medications and Procedures and Other Restrictions 
6.7.1 
Concomitant Medications and Procedures 
Any medication taken by a subject from 30 days prior to the screening visit through the first 
43 days of the study and the reason for its use will be documented. 
Previous prescription medication for mild chronic health disorders (eg, hypertension or 
hypercholesterolemia) or maintenance (eg, contraception) will be allowed at the discretion of the 
Investigator as long as the subject has been on a stable dose for at least 3 months. Subjects should 
continue their regular maintenance medications throughout study participation unless instructed to 
discontinue or change by the Investigator or their personal physician. If concomitant medications 
are discontinued by a subject during study conduct the subject should notify the Investigator. 
Subjects should refrain from starting new medications, modifying current concomitant 
medications, or receiving vaccinations during study participation unless prescribed by the 
Investigator for treatment of specific clinical events. 
Subjects should not receive any vaccine within 1 month before screening. 
Subjects should not be using prescription medications for the prophylaxis of SARS-CoV-2. 
Subjects should not participate or plan to participate in a study that involves an experimental agent 
(vaccine, drug, biologic, device, or medication); or should not have received an experimental agent 
within 1 month before enrollment in this study; or who expect to receive another experimental 
agent during participation in this study. 
A positive drug screen result with a corresponding prescribed concomitant medication will be 
allowed if, in the opinion of the investigator and Medical Monitor, the concomitant medication 
does not make the subject unsuitable to participate in the clinical trial. 
6.7.2 
Other Restrictions 
Subjects will be instructed to adhere to the following restrictions: 
• Strenuous activity (as assessed by the Investigator) is prohibited from 48 hours prior to the 
days safety laboratory blood will be collected 
• Subjects are not permitted to consume alcohol for 3 days prior to vaccination and should 
refrain from consumption of alcohol until 7 days post vaccination. 
• Subjects should refrain from blood donation for 6 months post vaccination. 
• Subjects should not participate or plan to participate in a study that involves an 
experimental agent (vaccine, drug, biologic, device, or medication); or should not have 
received an experimental agent within 1 month before enrollment in this study; or who 
expect to receive another experimental agent during participation in this study. 

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7 
STUDY ASSESSMENTS AND PROCEDURES 
Subjects will undergo study procedures and assessments at time points specified in the Schedule 
of Assessments and Procedures (Table 1-1). 
7.1 
Pandemic Safety Procedures 
Appropriate measures will be taken to ensure the safety of both study staff and study subjects 
including social distancing and appropriate personal protective equipment. 
7.2 
Medical and Surgical History 
The Investigator or designee will collect a complete medical and surgical history at screening. 
Medical and surgical history will be collected at CRU visits to determine if any changes have 
occurred since screening. 
7.3 
Demographic Characteristics 
Demographic characteristics including sex, age, race, and ethnicity will be recorded. Tobacco use 
and history will also be documented. 
7.4 
Physical Measurements 
Height (cm) and body weight (kg) without shoes will be recorded. BMI will be calculated using 
the height obtained at screening. 
7.5 
Immunogenicity 
Blood samples for antibody titers will be collected per Table 1-1 to assess: 
• Vaccine (ELISA for IgM and IgG, total antibody) and neutralizing antibody titers (virus 
microneutralization) for each treatment group: 
o GMT ratio (GMTplacebo/GMTTAP-COVID-19)  
o Seroconversion rate is defined as the proportion of subjects at the respective time 
point that have detectable antibodies (IgG and IgM) against SARS-CoV-2 Spike 
Protein RBD following challenge with vaccine (and potentially by natural 
asymptomatic or symptomatic infection by the virus in case of a placebo subject).  
• Anti-RBD and anti-Fc antibodies 
Blood samples for cellular immunity (PBMCs) will be collected per Table 1-1. The numbers of 
cytokine producing CD4+ and CD8+ T-cells from PBMCs responsive to vaccine antigens will be 
analyzed using a validated procedure. 
PBMC and serum samples for future research will also be collected (5-7 aliquots [1 mL]) at the 
time points outlined in Table 1-1. 
Immunogenicity sample collection, processing, and shipping details will be outlined in a separate 
SRM. 

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7.6 
SARS-CoV-2 Exposure and Asymptomatic Monitoring  
Subjects will be monitored for SARS-CoV-2 exposure for potential asymptomatic infection 
throughout the study. CRU staff will interview subjects about any potential exposure to the virus. 
If a subject has had potential exposure, the CRU will perform an unscheduled nasopharyngeal 
swab. Subjects will not be discontinued from the study due to positive SARS-CoV-2 test results. 
• If a subject has a positive or borderline ELISA anti-N IgG result, sites should have the 
subject return for an unscheduled PCR. If the ELISA is positive and the PCR is negative, 
the sites should follow the subjects using the standard of care under Investigator discretion, 
retesting ELISA at the next study visit(s) or sooner (per the Investigator’s decision). 
• If the subject has a positive or borderline ELISA anti-N IgG AND a positive PCR test, the 
clinical sites should bring the subjects back for repeat PCR testing as described below. 
• The clinical sites should continue to collect PCR tests if a subject is experiencing possible 
COVID-19 symptoms, or had possible exposure to SARS-CoV-2 (ie, close contact tests 
positive for SARS-CoV-2). Testing will occur every 2 weeks for a total of 4 weeks (if 
2 consecutive negative tests) or until negative (x2) after a positive result. Positive results 
will be reported as an AESI (Section 8.2.2) and subjects followed for disease severity, 
duration, and outcome. 
Telephone visits will be conducted to augment the in person visits through 6 months post-
vaccination (Table 1-1). CRU staff will interview the subjects about any potential exposure to the 
virus. If a subject has had potential exposure, the CRU will ask the subject to come in for an 
unscheduled visit that will include a nasopharyngeal swab.  
Subjects will be reminded at onsite visits and during telephone visits to contact the clinical site 
any time there is potential exposure to SARS-CoV-2 or they are experiencing any respiratory 
disease/symptoms suggestive of SARS-CoV-2 infection.  
7.7 
Safety Assessments 
7.7.1 
Adverse Events 
Subjects will be monitored for AEs according to Section 8. 
If a subject experiences respiratory symptoms suggestive of SARS-CoV-2 infection, the subject 
should notify the clinical site for a visit to collect nasopharyngeal swabs for RT-PCR virus 
detection. 
Subjects with positive ELISA anti-N IgG results without COVID-19 symptoms may indicate 
asymptomatic SARS-CoV-2 infection and will be followed with the appropriate standard of care. 
Subjects with a positive ELISA anti-N IgG result should have a PCR test and be followed until 
both are negative as in the protocol instructions (Section 7.6). 

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7.7.2 
Reactogenicity Assessments 
Subjects will keep a Diary Card to track reactogenicity assessments for 7 days after each 
vaccination. Reactogenicity assessments include generalized symptoms such as headache, fatigue, 
muscle pain, joint pain, nausea, chills, fever, and rash (not at injection site), and localized reactions 
including pain, erythema, induration, and swelling. If an AE continues after 7 days, the AE will be 
captured as ongoing/continuing (not noted as a new AE).  
7.7.3 
Laboratory Tests 
A certified laboratory will be utilized to process and provide results for the clinical safety 
laboratory tests listed in Table 7-1. The baseline laboratory test results for clinical assessment for 
a particular test will be defined as the last measurement prior to the first dose of study vaccine. 
Subjects will fast a minimum of 8 hours prior to clinical laboratory sample collection at screening. 
During the screening period, if a subject has an out-of-range value for a clinical safety laboratory 
parameter that the Investigator believes is not clinically significant or the Investigator does not 
believe is correct (eg, lab or specimen processing error), but the Investigator wants to confirm with 
a repeat laboratory test, a single repeat is allowed to confirm the initial result. 
If Part C Expansion (optional) is performed, all Part C subjects will have safety laboratory tests 
performed at screening only in order to satisfy the inclusion/exclusion criteria. In addition, the first 
200 subject in Part C will have safety laboratory tests performed at all time points. The remaining 
subjects in Part C will not have safety laboratory tests performed at any of the post-dose time 
points unless the Investigator deems it necessary.  
Additional safety laboratory tests may be conducted as needed by the Investigator to evaluate 
subject safety. 

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Table 7-1 
Clinical Safety Laboratory and Screening Tests 
Hematology 
Chemistry 
Urinalysis 
Hematocrit 
Hemoglobin 
Red blood cell count 
White blood cell count 
Neutrophils (absolute) 
Lymphocytes (absolute) 
Monocytes (absolute) 
Basophils (absolute) 
Eosinophils (absolute) 
Platelet count (estimate 
not acceptable) 
Albumin 
Alkaline phosphatase 
Alanine 
aminotransferase 
Aspartate 
aminotransferase 
Gamma glutamyl 
transferase 
Direct bilirubin 
Total bilirubin 
Lactate dehydrogenase 
Total protein 
Blood urea nitrogen 
Creatinine 
Calcium 
Phosphate 
Sodium 
Potassium 
Carbon dioxide 
Chloride 
Glucose a 
Total cholesterol 
Triglycerides a 
Specific gravity 
Ketones 
pH 
Protein 
Blood 
Glucose 
Leukocyte esterase 
Microscopic analysis (performed if 
blood, leukocytes, or protein are 
present) 
Urine Drugs of 
Abuseb,c 
Serology d 
Other 
 
Barbiturates 
Cocaine 
Tetrahydrocannabinol 
Amphetamines 
Opiates 
Phencyclidine 
HIV-1 
HIV-2 
HBsAg 
HCV antibody 
Prothrombin 
Pregnancy test 
Follicle-stimulating 
hormone e 
Alcohol screenc 
 
a. 
Fasting required at screening only 
b. At a minimum, these tests must be included 
c. 
During the screening period, urine drugs of abuse and alcohol screens may not be repeated for eligibility 
d. Includes any confirmatory tests performed at the discretion of the Investigator 
e. 
As needed to confirm postmenopausal status 
For any laboratory test value outside the reference range that the Investigator considers clinically 
significant during the on-study period (ie, following dose administration), the Investigator will: 
• Repeat the test to verify the out-of-range value and clinical significance. 
• Follow the out-of-range value until the value returns to normal or baseline, or until the value 
is deemed stable and not clinically significant by the Investigator. 
• Record as an AE any laboratory test value that is confirmed by repeat and the Investigator 
considers clinically significant, requires a subject to be discontinued from the study, requires 
a subject to receive treatment, or requires a change or discontinuation of the study vaccine 
(if applicable). 
7.7.4 
Vital Signs 
Vital signs assessments will include systolic and diastolic blood pressure (mmHg), heart rate 
(bpm), respiratory rate (breaths per minute), and oral temperature (C°). In addition, oral 
temperature will be performed prior to each vaccination. Vital signs will be measured after the 
subject has been resting quietly in a seated position for at least 5 minutes. Any clinically significant 
abnormal vital sign assessment requires at least one repeat measurement. 

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A vital signs abnormality that is considered clinically significant initially and on confirmation, 
requires a subject to be discontinued from the study, requires a subject to receive treatment, or 
requires discontinuation from the study vaccine (if applicable) will be recorded as an AE. 
7.7.5 
Physical Examination 
Comprehensive physical examinations (excluding genital, rectal, and breast examinations [unless 
indicated]) will be performed, and abnormal findings will be documented in the subject’s eCRF. 
Targeted physical examinations will focus on any AEs ongoing at the time of the examination 
(Table 1-1). 
An abnormal physical examination finding that is considered clinically significant and requires the 
subject to be discontinued from the study, requires the subject to receive treatment, or requires 
discontinuation of the study vaccine (if applicable) will be recorded as an AE. 
7.7.6 
Appropriateness of Safety Assessments 
Safety evaluations selected for this study are typical of those for this subject population and utilize 
widely accepted measures. 

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8 
ADVERSE EVENTS 
An AE is defined as any untoward medical occurrence in a subject administered a pharmaceutical 
product during the course of a clinical investigation. An AE can therefore be any unfavorable and 
unintended sign, symptom, or disease temporally associated with the use of a study vaccine, 
whether or not thought to be related to the study vaccine. A TEAE is any AE that occurs after the 
first dose of study drug, regardless of relationship to the study drug. 
MAAEs are AEs for which the subject has received medical attention by medical personnel, or in 
an emergency room, or which led to hospitalization. For each reported AE, the Investigator will 
ask the subject if such medical attention has been received. In addition, the Investigator will assess 
each MAAE if it constitutes a NOCD, defined as a MAAE that was:  
• absent at baseline,  
• not resolved at EOS  
• required continuous medical care or attention. 
Subjects will be monitored throughout the study for AEs, from the first dose of study vaccine 
through Day 43 of the study and for SAEs, MAAEs, NOCDs, and AESIs from the first dose 
through the end of the study (Day 365 ±14 days). Adverse events that are identified at the last 
assessment visit (or the early termination visit) as specified in the protocol must be recorded on 
the AE eCRF with the status of the AE noted. All events that are ongoing at this time will be 
recorded as ongoing on the eCRF. All (both serious and nonserious) AEs must be followed until 
they are resolved or medically stable, or until reasonable attempts to determine resolution of the 
event are exhausted. The Investigator should use his/her discretion in ordering additional tests as 
necessary to monitor the resolution of such events. 
The procedures specified in Section 8.4 are to be followed for reporting SAEs. 
8.1 
Recording Adverse Events 
Adverse events are to be recorded on the AE page of the eCRF. The following information will be 
recorded:  
• Assessment of whether or not the AE is an SAE, MAAE, NOCD, or AESI (Section 8.2.1) 
• Assessment of AE intensity (Section 8.2.2) 
• Assessment of AE relationship to study vaccine (Section 8.2.4) 
• Action taken - dose not changed, vaccine dose 2 not given, not applicable, or unknown, 
as applicable 
• Outcome - recorded as fatal, not recovered/not resolved, recovered/resolved, 
recovered/resolved with sequelae, recovering/resolving, or unknown, as applicable 

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8.2 
Assessment of Adverse Events 
The Investigator will assess each AE for seriousness, intensity, and relationship to study vaccine. 
8.2.1 
Serious Adverse Events, Medically Attended Adverse Events, New Onset 
Chronic Medical Conditions, Adverse Events of Special Interest, and 
Potential Immune-mediated Conditions 
The Investigator is responsible for determining whether an AE meets the definition of an SAE, 
MAAE, NOCDs, or AESIs including potential immune-mediated medical condition from the first 
dose of the study vaccine through the end of the study (Day 365 ±14 days).  
An SAE is any AE that results in any of the following outcomes: 
• Death 
• A life-threatening adverse drug experience 
• Inpatient hospitalization or prolongation of existing hospitalization 
• A persistent or significant disability/incapacity 
• A congenital anomaly/birth defect 
Important medical events that may not result in death, be life threatening, or require hospitalization 
may be considered an SAE when, based upon appropriate medical judgment, they may jeopardize 
the subject and may require medical or surgical intervention to prevent any of the outcomes listed 
in this definition. Examples of such medical events include allergic bronchospasm requiring 
intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not 
result in inpatient hospitalization, or the development of drug dependency or drug abuse. 
MAAEs are defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit 
to or from medical personnel for any reason. 
NOCDs are defined as any new ICD diagnosis (per current International Statistical Classification 
of Diseases and Related Health Problems) that is applied to the subject during the course of the 
study, after receipt of the study agent, that is expected to continue for at least 3 months and requires 
continued health care intervention. 
AESIs are defined in Section 8.2.2 and a list of potential immune-mediated medical conditions is 
provided in Appendix B. 
Note: SAEs, MAAEs, NOCDs, and AESIs including potential immune-mediated medical 
conditions require immediate reporting to the medical monitor and/or Sponsor. Refer to 
Section 8.4 for details. 
8.2.2 
Adverse Events of Special Interest 
An AESI is any AE that a regulatory authority has mandated be reported on an expedited basis 
(including to the iSRC), regardless of the seriousness, expectedness, or relatedness of the AE to 

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the administration of investigational product. To date, no AESIs have been identified specifically 
for the TAP-COVID-19 vaccine + CpG adjuvant. However, subjects who test positive for 
COVID-19, present with autoimmune disease, or are diagnosed with a potential immune-mediated 
medical condition (Appendix B) should be reported as AESI.  
AESIs will be followed as per the procedures in the study protocol, SRM, and/or SAE SSP for 
SAEs and pregnancy reporting, regardless of the seriousness, expectedness, or relatedness of the 
AESI to the administration of study vaccine. AESIs will be reported by the site directly to the 
Sponsor, medical monitor, and SAE hotline at ICON (ICON Pharmacovigilance) (Section 8.4). 
Subjects positive for SARS-CoV-2 will not be discontinued. Positive SARS-CoV-2 cases will be 
followed and include referral to a primary care physician, collection of all medical records, 
assessment of severity, and review by the site investigator and medical monitor. All positive 
SARS-CoV-2 cases will also be shared with the iSRC on an ongoing basis. 
8.2.3 
Intensity 
The intensity of an AE will be graded according to Guidance for Industry: Toxicity Grading Scale 
for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials 
(September 2007). The grading scale is comprised of 4 levels: mild (Grade 1), moderate (Grade 2), 
severe (Grade 3), and potentially life-threatening (Grade 4). For those AEs that are not covered in 
the Guidance for Industry (above) the rating scale from DAIDS (Table for Grading the Severity of 
Adult and Pediatric Adverse Events, Version 2.1) will be used (Table 8-1). 
Table 8-1 
DAIDS Adverse Events Intensity Assessment 
Grade 
Intensity 
Definition 
Grade 1 
Mild 
Symptoms causing no or minimal interference with usual social and 
functional activities with intervention not indicated. 
Grade 2 
Moderate 
Symptoms causing greater than minimal interference with usual social 
and functional activities with intervention indicated. 
Grade 3 
Severe 
Symptoms causing inability to perform usual social and functional 
activities with intervention or hospitalization indicated. 
Grade 4 
Potentially  
Life-Threatening 
Symptoms causing inability to perform basic self-care functions with 
intervention indicated to prevent permanent impairment, persistent 
disability, or death. 
Grade 5 
 
Any AE where the outcome is death 
8.2.4 
Relationship to Study Vaccine 
The relationship of an AE to the study vaccine should be determined by the Investigator according 
to the following criteria: 
• Not related: The event is most likely produced by other factors such as the subject’s clinical 
condition, intercurrent illness, or concomitant drugs, and does not follow a known response 
pattern to the study vaccine, or the temporal relationship of the event to study vaccine 
administration makes a causal relationship unlikely 

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• Related: The event follows a reasonable temporal sequence from the time of drug 
administration, and/or follows a known response pattern to the study vaccine, and cannot 
be reasonably explained by other factors such as the subject's clinical condition, 
intercurrent illness, or concomitant drugs 
8.3 
Discontinuation Due to Adverse Events 
Any subject who experiences an AE may be withdrawn at any time from the study at the discretion 
of the Investigator. Subjects withdrawn from the study due to an AE, whether serious or 
nonserious, may be followed by the Investigator until the clinical outcome of the AE is determined. 
The subject will also be asked to participate in a Follow-up Visit at approximately Day 365 to 
check safety and immunogenicity. The AE(s) should be noted on the appropriate eCRFs, the 
subject’s progress should be followed until the AE is resolved or medically stable as determined 
by the Investigator, and the Sponsor notified.  
8.4 
Reporting Serious Adverse Events and Adverse Events of Special Interest 
In the event of any SAE or AESI reported or observed during the study, whether or not attributable 
to the study vaccine, site personnel will report it immediately by telephone to the Sponsor, medical 
monitor, AND SAE hotline at ICON (ICON Pharmacovigilance) in accordance with procedures 
described in the SRM and/or SAE SSP. Site personnel will follow up with a written report on the 
next working day. 
Report Forms will be provided to the CRU to assist in collecting, organizing, and reporting SAEs 
or AESIs and follow-up information. 
All SAEs and AESIs should be followed to their resolution, with documentation provided to the 
Sponsor/ICON on a follow-up Report Form. 
8.5 
Pregnancy 
Pregnancies will be captured if they occur in female subjects from the time the subject is first 
exposed to the study vaccine until EOS. Pregnancies in the sexual partners of male subjects will 
be captured from the time the subject is first exposed to the study vaccine until 90 days after last 
exposure to the study vaccine. 
Female subjects must be instructed to inform the study Investigator immediately if they become 
pregnant during the study. 
The Investigator must report any pregnancy to the medical monitor, Sponsor, and ICON 
Pharmacovigilance within 1 business day of becoming aware of the pregnancy per pregnancy 
reporting procedures described in the SRM. The subject must be immediately discontinued from 
further treatment with study vaccine. An uncomplicated pregnancy will not be considered an AE 
or SAE; however, all pregnancies will be followed through birth and 3 months postdelivery. 
Any congenital abnormalities in the offspring of a subject who received study vaccine will be 
reported as an SAE. The outcome of any pregnancy and the presence or absence of any congenital 

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abnormality will be recorded in the source documentation and reported to the Sponsor and ICON 
Pharmacovigilance. 
8.6 
Drug-induced Liver Injury 
Subjects will be monitored for signs of DILI. Study vaccine (dose 2) will be withheld in the event 
of potential DILI. 
Potential events of DILI will be defined as meeting all of the following criteria (as specified in the 
FDA Guidance for Industry Drug-induced Liver Injury: Premarketing Clinical Evaluation, 2009): 
• ALT or AST >3 × ULN 
• Total bilirubin >2 × ULN without initial findings of cholestasis (elevated serum ALP) 
• No other reason can be found to explain the combination of laboratory value increases 
(eg, acute viral hepatitis; alcoholic and autoimmune hepatitis; hepatobiliary disorders; 
nonalcoholic steatohepatitis; cardiovascular causes; concomitant treatments) 
Potential events of DILI will be reported as SAEs (Section 8.4). All subjects with potential DILI 
will be closely followed until abnormalities return to normal or baseline or until reasonable 
attempts to determine resolution of the event are exhausted. 

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9 
STATISTICAL CONSIDERATIONS 
The statistical analysis will be conducted following the principles as specified in ICH Topic E9 
(CPMP/ICH/363/96). 
All statistical analyses will be described in a separate SAP. 
The statistical evaluation will be performed using SAS® software version 9.4 or higher (SAS 
Institute, Cary, NC). All data will be listed, and summary tables will be provided. No formal 
significance testing will be performed. Summary statistics will be presented by treatment group 
and include subset analysis (eg, all subjects, seronegative subjects [ie, neutralizing antibody titer 
< 10 at screening], seropositive subjects, and subjects that received an FDA Emergency Use 
Authorization/licensed COVID vaccine). For continuous variables, data will be summarized with 
the number of subjects, mean, standard deviation, median, minimum, maximum, geometric mean, 
CV%, GeoCV%, and 95% CI by treatment group. For categorical variables, data will be tabulated 
with the number and proportion of subjects for each category by treatment group.  
The database will be locked and unblinded after the data have been monitored for all subjects 
through Day 43. Details of the unblinded interim analysis are presented in Section 9.5. 
The final analysis of the safety and immunogenicity data collected from Day 43 through 
Day 365/approximately 1 year after first vaccination will be performed after the study is 
completed. An addendum to the initial CSR will be prepared with data from final analysis. Details 
of the statistical analyses, methods, and data conventions will be described in the SAP.  
9.1 
Sample Size Calculation 
No formal sample size calculation was performed.  
A total of 180 subjects will be enrolled in Parts A and B. Approximately 90 eligible subjects (aged 
18-49 years), with 30 subjects per treatment group for Part A and 90 eligible subjects (aged 
50-85 years), with 30 subjects per treatment group for Part B, will be enrolled in the study.  
An optional Part C Expansion may be conducted to confirm the safety and immunogenicity of the 
selected dose of vaccine in up to 1000 adult subjects randomized 1:1 (single dose level of study 
vaccine:placebo). The proposed sample size was selected based on WHO guidelines on clinical 
evaluation of vaccines: regulatory expectations Annex I (2001), which states that approximately 
300 subjects are needed to identify common local reactogenicity events. A larger sample size will 
assist in a better characterization of kinetics and range of immunity (neutralizing antibody titers) 
and provide a more reliable output of seropositivity and seroconversion to TAP-COVID-19 
immunization. With the limited clinical experience with SARS-CoV-2 vaccines and the current 
lack of a biomarker correlate of protection, the generation of this larger data set is relevant to 
inform the design and implementation of a Phase 3 program. 
9.2 
Analysis Populations 
Enrolled Population: All subjects who signed the ICF. 

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Safety Population: All subjects who provide consent, are randomized, and receive any amount of 
study vaccine/placebo. The Safety Population will be used for the demographic, baseline 
characteristic, safety data summaries, and the analysis of primary endpoints such as occurrence of 
solicited local and systemic reactogenicity. 
Per Protocol (PP) Population: Includes all subjects in the Safety Population who receive the 
assigned doses of the study vaccine/placebo according to protocol, have serology results, and have 
no major protocol deviations affecting the primary immunogenicity outcomes, as determined by 
the Sponsor before database lock and unblinding. Subjects that are immunized with an approved 
vaccine will be captured as a subset analysis of the PP Population at Days 90, 181, 273, and 365 
based on the date of receiving an approved COVID-19 vaccine. 
Modified Intent-to-Treat (mITT) Population: Includes all subjects in the Safety Population who 
provide any serology data. The mITT Population will be used for the immunogenicity analysis.  
9.3 
Randomization 
The overall randomization for the study will be 2:1 (active:placebo). Each Part (A and B) and 
treatment (low and high) will be randomized individually 2:1 (active to placebo).  
The study will start with Part A (18-49 years) low dose, randomized in a 2:1 ratio (30 subjects 
active:15 subjects placebo) for Treatment A (15 μg TAP-COVID-19 vaccine + 0.5 mg CpG). 
Part A (18-49 years) high dose will be randomized in a 2:1 ratio (30 subjects active:15 subjects 
placebo) for Treatment B (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG) after Part A low dose 
has completed enrollment and the iSRC has reviewed safety and tolerability data through Day 8. 
Part B (50-85 years) low dose will be randomized in a 2:1 ratio (30 subjects active:15 subjects 
placebo) for Treatment A (15 μg TAP-COVID-19 vaccine + 0.5 mg CpG) after Part A low dose 
has completed enrollment and received the first vaccination and the iSRC has reviewed safety data 
through Day 8. 
Part B (50-85 years) high dose will be randomized in a 2:1 ratio (30 subjects active:15 subjects 
placebo) for Treatment B (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG) after Part B low dose 
has completed enrollment and received the first vaccination and the iSRC has reviewed safety data 
through Day 8. 
A total of 90 subjects will be randomized in Part A (18-49 years); 30 subjects low dose (Treatment 
A, 15 μg TAP-COVID-19 vaccine + 0.5 mg CpG), 30 subjects high dose (Treatment B, 45 μg 
TAP-COVID-19 vaccine + 0.5 mg CpG), and 30 subjects placebo (Treatment C). 
A total of 90 subjects will be randomized in Part B (50-85 years); 30 subjects low dose (Treatment 
A, 15 μg TAP-COVID-19 vaccine + 0.5 mg CpG), 30 subjects high dose (Treatment B, 45 μg 
TAP-COVID-19 vaccine + 0.5 mg CpG), and 30 subjects placebo (Treatment C). 
Treatment A: TAP-COVID-19 vaccine (15 μg) + CpG (0.5 mg) IM injection on 
Day 1 and Day 22 (±3 days) 

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Treatment B: TAP-COVID-19 vaccine (45 μg) + CpG (0.5 mg) IM injection on 
Day 1 and Day 22 (±3 days) 
Treatment C: Placebo (buffered saline solution) IM injection on Day 1 and Day 22 
(±3 days) 
A computer-generated randomization schedule for each part (Part A, Part B, and Part C Expansion) 
will be generated prior to study start by an ICON biostatistician. 
For sentinel dosing, 3 subjects from each part will be randomized 2:1 (active:placebo). The 
remainder of each cohort will also be randomized 2:1 (active:placebo).  
9.4 
Endpoints 
Endpoints are presented in Section 3.2. 
9.5 
Interim Analyses 
An unblinded interim analysis will be performed on the safety and immunogenicity data 
collected for each of the 4 dose groups (Part A low dose, Part A high dose, Part B low dose, and 
Part B high dose). Unblinded interim analysis will occur for the Part A low dose group 
(including active and placebo subjects) when the first 30 subjects vaccinated have data available 
from Day 1 through Day 43. The remaining cohorts will have an unblinded interim analysis 
performed when all subjects in the cohort have data from Day 1 through Day 43. For the interim 
analysis, treatment codes will be unblinded after the data are deemed ready for the analysis and 
the data has been monitored. The CRO [except for the unblinded team members preparing the 
data for unblinded iSRC review], Investigator, and clinical staff will not have access to the 
unblinded treatment group interim analyses and will remain blinded until completion of the 
study. The Sponsor will be unblinded at the interim analysis. Safety and immunogenicity 
analyses from this unblinded interim analysis will be presented in a CSR. This CSR may be 
submitted to regulatory authorities as needed.  
9.6 
Immunogenicity Analysis 
The mITT Population will be used for all listings and summary statistics corresponding to 
immunogenicity analysis.  
The individual sampling and blood collection for ELISA analysis to determine IgG and IgM 
antibody titers to the spike RBD and neutralizing antibody titers for parent (Wuhan) and any 
variant SARS-CoV-2 strains, will be listed and summarized by time points for each part by 
treatment.  
All derived immunogenicity secondary endpoint parameters: GMT, GMT ratio, GMFR, GMI, and 
seroconversion rates will be listed and summarized by scheduled time point using descriptive 
statistics (n, mean, SD, minimum, median, maximum, geometric mean, CV%, GeoCV%, and 95% 
CI) for each part by treatment. 

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PBMC and serum sample data for future research results at each scheduled visit will also be 
provided separately in a listing and summary table, if applicable. 
Subgroup analysis for safety and efficacy will be performed for those subjects who were 
seropositive when enrolled. 
Graphical display of the summary results or at individual time points will be provided as needed 
(eg, scatter plots of subject titer values to visually display individual data points). 
Additional details for analysis of immunogenicity are presented in the SAP. 
9.7 
Cellular Analysis 
The number of IFN-γ and IL-5 producing T-cells (CD4+ and CD8+) from PBMCs responsive to 
vaccine antigens will be listed and summarized by time point using appropriate descriptive 
statistics for each part by treatment. 
Additional details for cellular analysis are presented in the SAP. 
9.8 
Safety Analysis 
Safety Population will be used for all safety variables specified.  
All safety data will be summarized by part and treatment. No statistical tests will be performed. 
Subjects who are seropositive and seronegative at screening will also be summarized and safety 
and efficacy subgroup analysis will be performed for these groups of subjects. 
Additional details for safety analysis are presented in the SAP. 

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10 
ACCESS TO SOURCE DATA/DOCUMENTS 
The Investigator will provide direct access to source data and documents for individuals 
conducting study-related monitoring, audits, IRB review, and regulatory review. The Investigator 
must inform the study subject that his/her study-related records may be reviewed by the above 
individuals without violating the subject’s privacy of personal health information in compliance 
with HIPAA regulations. 
Attention is drawn to the regulations promulgated by the FDA under the Freedom of Information 
Act providing, in part, that information furnished to clinical Investigators and IRBs will be kept 
confidential by the FDA only if maintained in confidence by the clinical Investigator and IRB. By 
signing this protocol, the Investigator affirms to the Sponsor that the Investigator will maintain, in 
confidence, information furnished to him or her by the Sponsor and will divulge such information 
to the IRB under an appropriate understanding of confidentiality with such board. 

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11 
QUALITY CONTROL AND QUALITY ASSURANCE 
Sponsor/ICON will implement and maintain quality control and quality assurance procedures with 
written SOPs to ensure the study is conducted and data are generated, documented, and reported 
in compliance with the protocol, GCP, and applicable regulatory requirements. 
11.1 
Conduct of Study 
This study will be conducted in accordance with the provisions of the Declaration of Helsinki and 
all revisions thereof (Tokyo 2004), and in accordance with FDA CFR (§312.50 and §312.56) and 
the ICH E6 Guidelines on GCP (CPMP/ICH/135/95). Specifically, this study is based on 
adequately performed laboratory and animal experimentation; the study will be conducted under 
a protocol reviewed by an IRB; the study will be conducted by scientifically and medically 
qualified persons; the benefits of the study are in proportion to the risks; the rights and welfare of 
the subjects will be respected; the physicians conducting the study do not find the hazards to 
outweigh the potential benefits; and each subject will give his or her written, informed consent 
before any protocol-driven tests or evaluations are performed. 
The Investigator may not deviate from the protocol without a formal protocol amendment having 
been established and approved by an appropriate IRB, except when necessary to eliminate 
immediate hazards to the subject or when the change(s) involve only logistical or administrative 
aspects of the study and are approved by the Sponsor. Any deviation may result in the subject 
having to be withdrawn from the study, and may render that subject nonevaluable. 
11.1.1 
Protocol Deviations 
A protocol deviation is defined as any intentional or unintentional change to, or noncompliance 
with, the approved protocol procedures or requirements. Deviations may result from the action or 
inaction of the subject, Investigator, or site staff. 
At the outset of the study, a process for defining and handling protocol deviations will be 
established. This will include determining which violations will be designated “key,” requiring 
immediate notification to the medical monitor and/or Sponsor. The Investigator is responsible for 
seeing that any known protocol deviations are recorded and handled as agreed. 
11.2 
Protocol Amendments 
Only the Sponsor may modify the protocol. Amendments to the protocol will be made only after 
consultation and agreement between the Sponsor and the Investigator. All amendments that have 
an impact on subject risk or the study objectives, or require revision of the ICF, must receive 
approval from the IRB prior to their implementation.  
11.3 
Monitoring of Study 
The Investigator will permit the CRA to review study data as frequently as is deemed necessary to 
ensure data are being recorded in an adequate manner and protocol adherence is satisfactory. 

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The Investigator will provide access to medical records for the monitor to verify eCRF entries. 
The Investigator is expected to cooperate with the Sponsor or a designee in ensuring the study 
adheres to GCP requirements. 
The Investigator may not recruit subjects into the study until the Sponsor or a designee has 
conducted a site initiation visit (in-person or via teleconference) to review the protocol and eCRF 
in detail. 

Kentucky BioProcessing, Inc. 
Protocol Number: KBP-201 
Protocol Version 9.0 
 
CONFIDENTIAL 
12 November 2021 
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12 
ETHICS 
12.1 
Institutional Review Board Approval 
12.1.1 
Ethics Review Prior to Study 
The Investigator will ensure that the protocol and ICF are reviewed and approved by the 
appropriate IRB prior to the start of any study procedures. The IRB will be appropriately 
constituted and will perform its functions in accordance with FDA regulations, ICH GCP 
guidelines, and local requirements as applicable. 
12.1.2 
Ethics Review of Other Documents 
The IRB will approve all protocol amendments (except for Sponsor-approved logistical or 
administrative changes), written informed consent documents and document updates, subject 
recruitment procedures, written information to be provided to the subjects, available safety 
information, information about payment and compensation available to subjects, the Investigator’s 
curriculum vitae and/or other evidence of qualifications, and any other documents requested by 
the IRB and regulatory authority as applicable. 
12.2 
Written Informed Consent 
The nature and purpose of the study will be fully explained to each subject. The subjects must be 
given ample time and opportunity to inquire about details of the study, to have questions answered 
to their satisfaction, and to decide whether to participate. Written informed consent must be 
obtained from each subject prior to any study procedures being performed. 

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Protocol Number: KBP-201 
Protocol Version 9.0 
 
CONFIDENTIAL 
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13 
DATA HANDLING AND RECORD KEEPING 
13.1 
Data Reporting and Case Report Forms 
13.1.1 
Case Report Forms 
The Investigator will be provided with eCRFs, and will ensure all data from subject visits are 
promptly entered into the eCRFs in accordance with the specific instructions given. The 
Investigator must sign the eCRFs to verify the integrity of the data recorded. 
13.1.2 
Laboratory Data 
A list of the normal ranges for all laboratory tests to be undertaken forms part of the documentation 
to be collated prior to study start. If a central laboratory has been selected to conduct any or all 
tests, it is essential all samples be analyzed at that laboratory. The Investigator must maintain 
source documents such as laboratory reports and complete history and physical examination 
reports. 
13.1.3 
Retention of Source Documents 
The Investigator must maintain source documents such as laboratory reports, x-rays, ECGs, 
consultation reports, and complete history and physical examination reports. 
13.2 
Retention of Essential Documents 
The study essential documents must be maintained as specified in the ICH guidelines for GCP and 
the applicable regulatory requirements. The Investigator/institution should take measures to 
prevent accidental or premature destruction of these documents. 
Essential documents should be retained until at least 2 years after the last approval of a marketing 
application in an ICH region and until there are no pending or contemplated marketing applications 
in an ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical 
development of the study vaccine. These documents should be retained for a longer period; 
however, if required by the applicable regulatory requirements or by an agreement with the 
Sponsor. It is the responsibility of the Sponsor to inform the Investigator/institution as to when 
these documents no longer need to be retained. 

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14 
ADMINISTRATIVE INFORMATION 
14.1 
Financing and Insurance 
Financing and insurance will be addressed in a separate agreement between the Sponsor and the 
Investigator. 
14.2 
Publication Policy 
The Sponsor will retain ownership of all data. All proposed publications based on this study will 
be subject to Sponsor’s approval requirements. 

Kentucky BioProcessing, Inc. 
Protocol Number: KBP-201 
Protocol Version 9.0 
 
CONFIDENTIAL 
12 November 2021 
Page 68 
15 
REFERENCES 
Arnaboldi PM, Sambir M, D’Arco C, et al. Intranasal delivery of a protein subunit vaccine using 
a Tobacco Mosaic Virus platform protects against pneumonic plague. Vaccine. 2016 Nov 11; 
34(47): 5768–5776. 
Banik S, Mansour AA, Suresh RV, et al. Development of a multivalent subunit vaccine against 
tularemia using tobacco mosaic virus (TMV) based delivery system. PLoS One. 2015; 10(6): 
e0130858. 
Centers for Disease Control and Prevention. Coronavirus Disease 2019 (COVID-19). 
https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-
conditions.html. Last accessed 09 April 2021. 
de Alwis R, Chen S, Gan ES, et al. Impact of immune enhancement on Covid-19 polyclonal 
hyperimmune globulin therapy and vaccine development. EBioMedicine. 2020 May; 55: 102768. 
Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, 
Version 2.1. National Institute of Allergy and Infectious Diseases. 2017. Available at: 
https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf. Last accessed 15 August 
2020. 
Du L, Zhao G, He Y, et al. Receptor-binding domain of SARS-CoV spike protein induces long-
term protective immunity in an animal model. Vaccine. 2007 Apr 12;25(15):2832-8. 
Du L, Zhao G, Chan C, et al. Recombinant receptor-binding domain of SARS-CoV spike protein 
expressed in mammalian, insect and E. coli cells elicits potent neutralizing antibody and protective 
immunity. Virology. 2009 Oct 10; 393(1): 144–150. 
Fierz W and Walz B. Antibody Dependent Enhancement Due to Original Antigenic Sin and the 
Development of SARS. Front Immunol. 2020; 11: 1120. 
Guidance for Industry: Drug-Induced Liver Injury: Premarketing Clinical Evaluation (July 2009). 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-induced-liver-
injury-premarketing-clinical-evaluation. Last accessed 15 May 2020. 
Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers 
Enrolled in Preventive Vaccine Clinical Trials (September 2007). https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/toxicity-grading-scale-healthy-adult-and-
adolescent-volunteers-enrolled-preventive-vaccine-clinical. Last accessed 15 May 2020. 
Jaume M, Yip MS, Kam YW, et al. SARS CoV subunit vaccine: Antibody mediated neutralisation 
and enhancement. Hong Kong Med J. 2012 Feb;18 Suppl 2:31-6. 
Johns Hopkins Coronavirus Resource Center. Available at: https://coronavirus.jhu.edu/. Last 
accessed 15 May 2020.  
Kam YW, Kien F, Roberts A, et al. Antibodies against trimeric S glycoprotein protect hamsters 
against SARS-CoV challenge despite their capacity to mediate FcγRII-dependent entry into B cells 
in vitro. Vaccine. 2007 Jan 8;25(4):729-40.  
Mallajosyula JK, Jeevan T, Chikwamba R, et al. A single dose TMV-HA vaccine protects mice 
from H5N1 influenza challenge. Int. J. Vaccines Res. 2016 1(2):6. 

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Protocol Number: KBP-201 
Protocol Version 9.0 
 
CONFIDENTIAL 
12 November 2021 
Page 69 
Mallajosyula JK, Hiatt E, Hume S, et al. Single-dose monomeric HA subunit vaccine generates 
full protection from influenza challenge. Hum Vaccin Immunother. 2014;10(3):586-95. 
McCormick AA, Corbo TA, Wykoff-Clary S, et al. Chemical conjugate TMV - Peptide bivalent 
fusion vaccines improve cellular immunity and tumor protection. Bioconjug Chem. Sep-Oct 
2006a;17(5):1330-8. 
McCormick AA, Corbo TA, Wykoff-Clary S, et al. TMV-peptide fusion vaccines induce cell-
mediated immune responses and tumor protection in two murine models. Vaccine. 2006b Sep 
29;24(40-41):6414-23.  
National Heart, Lung, and Blood Institute, Calculate Your Body Mass Index. Available at: 
https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmi-m.htm. Last accessed 15 May 
2020. 
Quinlan BD, Mou H, Zhang L, et al. The SARS-CoV-2 receptor-binding domain elicits a potent 
neutralizing response without antibody-dependent enhancement. bioRxiv. 2020.04.10.036418. 
Wang N, Shang J, Jiang S, et al. Subunit Vaccines Against Emerging Pathogenic Human 
Coronaviruses. Front Microbiol. 2020; 11: 298. 
World Health Organization. Guidelines on clinical evaluation of vaccines: regulatory expectations 
Annex 
I. 
Available 
at: 
https://www.who.int/biologicals/publications/clinical_guidelines_ecbs_2001.pdf?ua=1. 
Last 
accessed: 05 October 2020.  

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16 
SIGNATURES 
Protocol Number: KBP-201 
Protocol 
Title: 
A 
Phase 
I/II, 
First-in-human, 
Observer-blinded, 
Randomized, 
Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of 
TAP-COVID-19 SARS-CoV-2 Vaccine with CpG Adjuvant in Healthy Adults Aged 18-49 
and 50-85 
Kentucky BioProcessing, Inc. Signatures 
This clinical study protocol has been reviewed and approved by Kentucky BioProcessing, Inc. 
 
 
 
 
 
 
 
Oscar (Tony) A. Guzman, MD, CP 
Clinical Project Lead 
 
Date 
 
11/17/2021

Kentucky BioProcessing, Inc. 
Protocol Number: KBP-201 
Protocol Version 9.0 
 
CONFIDENTIAL 
12 November 2021 
Page 71 
Protocol Number: KBP-201 
 
Protocol 
Title: 
A 
Phase 
I/II, 
First-in-human, 
Observer-blinded, 
Randomized, 
Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of 
TAP-COVID-19 SARS-CoV-2 Vaccine with CpG Adjuvant in Healthy Adults Aged 18-49 
and 50-85 
 
Investigator Signature 
I agree to conduct the aforementioned study according to the terms and conditions of the protocol, 
GCP guidelines, and all other applicable local and regulatory requirements. All information 
pertaining to the study will be treated in a confidential manner. 
 
 
 
Site Name 
 
 
 
Print Name 
 
 
 
 
 
Signature 
 
Date 
 

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Protocol Number: KBP-201 
Protocol Version 9.0 
 
CONFIDENTIAL 
12 November 2021 
Page 72 
APPENDIX A  
DIARY CARD EXAMPLE 
Example Diary Card may be adjusted to add additional subject collection information or CRU 
and/or subject contact information. 
 

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Protocol Number: KBP-201 
Protocol Version 9.0 
 
CONFIDENTIAL 
12 November 2021 
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Kentucky BioProcessing, Inc. 
Protocol Number: KBP-201 
Protocol Version 9.0 
 
CONFIDENTIAL 
12 November 2021 
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APPENDIX B  
POTENTIAL IMMUNE-MEDIATED MEDICAL CONDITIONS 
Gastrointestinal Disorders 
• Autoimmune pancreatitis 
• Celiac disease 
• Crohn’s disease 
• Microscopic colitis 
• Ulcerative colitis 
• Ulcerative proctitis 
Liver Disorders 
• Autoimmune cholangitis 
• Autoimmune hepatitis 
• Primary biliary cirrhosis 
• Primary sclerosing cholangitis 
Metabolic Diseases 
• Addison’s disease 
• Autoimmune hypophysitis 
• Autoimmune thyroiditis (including Hashimoto thyroiditis) 
• Diabetes mellitus type I  
• Grave’s or Basedow’s disease 
Musculoskeletal Disorders 
• Antisynthetase syndrome 
• Dermatomyositis 
• Juvenile chronic arthritis (including Still’s disease) 
• Mixed connective tissue disorder 
• Polymyalgia rheumatic 
• Polymyositis 
• Psoriatic arthropathy 
• Relapsing polychondritis 
• Rheumatoid arthritis 
• Scleroderma, including diffuse systemic form and CREST (alcinosis, Raynaud’s 
phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia) syndrome 
• Spondyloarthritis, including ankylosing spondylitis, reactive arthritis (Reiter’s 
Syndrome), and undifferentiated spondyloarthritis 
• Systemic lupus erythematosus 
• Systemic sclerosis 
Neuroinflammatory Disorders 
• Acute disseminated encephalomyelitis, including site-specific variants (eg, noninfectious 
encephalitis, encephalomyelitis, myelitis, radiculomyelitis) 

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CONFIDENTIAL 
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• Cranial nerve disorders, including paralyses/paresis (eg, Bell’s palsy) 
• Guillain-Barré syndrome, including Miller Fisher syndrome and other variants  
• Immune-mediated peripheral neuropathies and plexopathies, including chronic 
inflammatory demyelinating polyneuropathy, multifocal motor neuropathy and 
polyneuropathies associated with monoclonal gammopathy 
• Multiple sclerosis 
• Narcolepsy  
• Optic neuritis 
• Transverse myelitis 
• Myasthenia gravis, including Eaton-Lambert syndrome 
Skin Disorders 
• Alopecia areata 
• Autoimmune bullous skin diseases, including pemphigus, pemphigoid and dermatitis 
herpetiformis 
• Cutaneous lupus erythematosus 
• Erythema nodosum 
• Morphoea 
• Lichen planus 
• Psoriasis 
• Sweet’s syndrome 
• Vitiligo 
Vasculitides 
• Large vessels vasculitis including: giant cell arteritis such as Takayasu's arteritis and 
temporal arteritis 
• Medium sized and/or small vessels vasculitis including the following:  
o Polyarteritis nodosa 
o Kawasaki’s disease  
o Microscopic polyangiitis 
o Wegener’ granulomatosis 
o Behcet’s syndrome 
o Leukocytoclastic vasculitis 
o Henoch-Schonlein purpura 
o Necrotizing vasculitis and antineutrophil cytoplasmic antibody (ANCA) positive 
vasculitis (type unspecified) 
o Churg-Strauss syndrome (allergic granulomatous angiitis) 
o Buerger’s disease thromboangiitis obliterans 
Others 
• Antiphospholipid syndrome 
• Autoimmune hemolytic anemia  

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• Autoimmune glomerulonephritis (including IgA nephropathy, glomerulonephritis rapidly 
progressive, membranous glomerulonephritis, membranoproliferative glomerulonephritis, 
and mesangioproliferative glomerulonephritis) 
• Autoimmune myocarditis/cardiomyopathy 
• Autoimmune neutropenia 
• Autoimmune pancytopenia 
• Autoimmune thrombocytopenia 
• Goodpasture syndrome 
• Idiopathic pulmonary fibrosis 
• Pernicious anemia 
• Polyglandular autoimmune syndrome 
• Raynaud’s phenomenon 
• Sarcoidosis 
• Sjögren’s syndrome 
• Stevens-Johnson syndrome 
• Uveitis 

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Protocol Number: KBP-201 
Protocol Version 9.0 
 
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12 November 2021 
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APPENDIX C  
ADDITIONAL ELISA DETAILS 
2) 
 
Name That 
Appears on 
Laboratory Report 
Vendor 
SARs-CoV-2 
Antigen 
Reporting 
Status 
Intended Use 
Anti-SARS-CoV-2 
IgG Qual 
Euroimmun 
Spike (S) 
Blinded 
starting at the 
Day 1 Visit 
It is intended for use as an aid in 
identifying individuals with an adaptive 
immune response to SARS-CoV-2, 
indicating recent or prior infection. At 
this time, it is unknown for how long 
antibodies persist following infection and 
if the presence of antibodies confers 
protective immunity. This test should not 
be used to diagnose acute SARS-CoV-2 
infection. 
SARS-CoV-2  
IgG Qual 
Abbott 
Architect 
Nucleocapsid 
(N) 
Unblinded 
throughout 
the duration 
of the study 
This assay is designed to detect 
immunoglobulin class G (IgG) antibodies 
to the nucleocapsid protein of 
SARS-CoV-2 in serum and plasma from 
individuals who are suspected to have 
had COVID-19 or in serum and plasma 
of subject that may have been infected by 
SARS-CoV-2. 
COVID-19 IgM 
Epitope 
Diagnostics 
Nucleocapsid 
(N) 
Unblinded 
throughout 
the duration 
of the study 
This test is used as an aid for the 
detection of novel COVID-19. 
 

Certificate Of Completion
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KBP-201 Amendment 8 (Final Protocol v9.0, dated 12 November 2021) Updates in FDA Tabular Format 
Protocol Section(s) of Current 
Version (Final Protocol v9.0, 
12 November 2021) Affected by 
Change 
Previous Version (Final Protocol v8.0, 
28 June 2021) Example Text 
Current Version (Final Protocol v9.0, 
12 November 2021) Example Text 
Rationale 
Synopsis (Objectives, Endpoints, 
Study Design),  
Sections 3.1.2, 3.2.2, 4.1, 9.6 
Section 9.6 Immunogenicity Analysis 
The individual sampling and blood 
collection for ELISA IgG for the 
spike/anti-RBD and IgM; neutralizing 
antibody, anti RBD and anti-Fc antibodies 
will be listed and summarized by time 
points for each part by treatment. 
Section 9.6 Immunogenicity Analysis 
The individual sampling and blood 
collection for ELISA analysis to determine 
IgG and IgM antibody titers to the spike 
RBD and neutralizing antibody titers for 
parent (Wuhan) and any variant SARS-
CoV-2 strains, will be listed and 
summarized by time points for each part by 
treatment. 
Clarification of the antibodies to be 
used for evaluation of immunogenicity.  
Synopsis (Study Design),  
Section 4.1.2, 5.7.1 
5.7.1 Independent Safety Review 
Committee 
The iSRC will be asked to review 
unblinded immunogenicity and safety data 
when the first 30 subjects vaccinated in the 
Part A low dose group (including active 
and placebo subjects) have data available 
from Day 1 through Day 43 for an 
assessment of the risk-benefit of the trial. 
The remaining study cohorts will have an 
unblinded immunogenicity and safety data 
review when all subjects in the cohort have 
data available from Day 1 through Day 43. 
5.7.1 Independent Safety Review 
Committee 
The iSRC will be asked to review 
unblinded immunogenicity and safety data 
when the first 30 subjects vaccinated in the 
Part A low dose group (including active 
and placebo subjects) have data available 
from Day 1 through Day 43 for an 
assessment of the risk-benefit of the trial.  
Due to cessation of subject enrollment, 
the Day 43 iSRC meeting will not be 
needed for the Part A high dose and 
Part B subjects. 
Sections 4.1.2, 5.7.1, 6.6.2, 6.6.3.2, 
9.5 
4.1.2 Interim Safety Data Review 
For the interim analysis, treatment codes 
will only be unblinded by treatment group 
(not by individual subjects) and only after 
the data are deemed ready for the analysis 
and the data has been monitored. The 
unblinded review will be completed by the 
iSRC only and the other team members 
(Sponsor, CRO [except for the unblinded 
team members preparing the data for 
4.1.2 Interim Safety Data Review 
For the interim analysis, treatment codes 
will be unblinded and only after the data 
are deemed ready for the analysis and the 
data has been monitored. The unblinded 
review will be completed by the iSRC only 
and the other team members (CRO [except 
for the unblinded team members preparing 
the data for unblinded iSRC review], 
Investigator, and site personnel) will 
Since there will be no additional 
subjects enrolled, the Sponsor will be 
unblinded to treatment while the 
remaining study team members remain 
blinded through the end of the study (~ 
1 year).  

KBP-201 Amendment 8 (Final Protocol v9.0, dated 12 November 2021) Updates in FDA Tabular Format 
Protocol Section(s) of Current 
Version (Final Protocol v9.0, 
12 November 2021) Affected by 
Change 
Previous Version (Final Protocol v8.0, 
28 June 2021) Example Text 
Current Version (Final Protocol v9.0, 
12 November 2021) Example Text 
Rationale 
unblinded iSRC review], Investigator, and 
site personnel) will remain blinded. 
remain blinded until completion of the 
study. The Sponsor will be unblinded at 
the interim analysis. 
Synopsis (Statistical Analysis),  
Section 9.2 
9.2 Analysis Populations 
Enrolled Population: All subjects who were 
screened and enrolled to the study. The 
Enrolled Population will include all screen 
failures 
and 
all 
subjects 
who 
are 
discontinued from the study prior to study 
vaccine administration and will be used for 
disposition summaries. 
Per Protocol (PP) Population: Includes all 
subjects in the Safety Population who 
receive the assigned doses of the study 
vaccine/placebo according to protocol, 
have serology results, and have no major 
protocol deviations affecting the primary 
immunogenicity outcomes, as determined 
by the Sponsor before database lock and 
unblinding. Subjects that are immunized 
with an approved vaccine will be captured 
as a subset analysis of the PP Population in 
six-month increments (Days 90-181 and 
181-365) based on the date of receiving an 
approved COVID-19 vaccine. 
9.2 Analysis Populations 
Enrolled Population: All subjects who 
signed the ICF.  
Per Protocol (PP) Population: Includes all 
subjects in the Safety Population who 
receive the assigned doses of the study 
vaccine/placebo according to protocol, 
have serology results, and have no major 
protocol deviations affecting the primary 
immunogenicity outcomes, as determined 
by the Sponsor before database lock and 
unblinding. Subjects that are immunized 
with an approved vaccine will be captured 
as a subset analysis of the PP Population at 
Days 181, 273, and 365 based on the date 
of receiving an approved COVID-19 
vaccine. 
Updates to the analysis population for 
consistency with the Statistical 
Analysis Plan. 
Synopsis (Statistical Analysis),  
Sections 9, 9.6 
Section 9.6 Immunogenicity Analysis 
All derived immunogenicity secondary 
endpoint parameters: GMT, GMT ratio, 
GMFR, GMI, and seroconversion rates 
will be listed and summarized by 
scheduled time point using descriptive 
statistics (n, mean, SD, minimum, median, 
Section 9.6 Immunogenicity Analysis 
All derived immunogenicity secondary 
endpoint parameters: GMT, GMT ratio, 
GMFR, GMI, and seroconversion rates will 
be listed and summarized by scheduled 
time point using descriptive statistics (n, 
mean, SD, minimum, median, maximum, 
Clarification that the immunogenicity 
secondary endpoint parameters GMT, 
GMT ratio, GMFR, GMI, and 
seroconversion rates will need 
geometric means, CV%, and GeoCV% 
summarized in addition to the 
arithmetic mean.  

KBP-201 Amendment 8 (Final Protocol v9.0, dated 12 November 2021) Updates in FDA Tabular Format 
Protocol Section(s) of Current 
Version (Final Protocol v9.0, 
12 November 2021) Affected by 
Change 
Previous Version (Final Protocol v8.0, 
28 June 2021) Example Text 
Current Version (Final Protocol v9.0, 
12 November 2021) Example Text 
Rationale 
maximum, and 95% CI) for each part by 
treatment. 
Graphical display of the summary results 
or at individual time points will be 
provided as needed. 
geometric mean, CV%, GeoCV%, and 
95% CI) for each part by treatment. 
Graphical display of the summary results 
or at individual time points will be 
provided as needed (eg, scatter plots of 
subject titer values to visually display 
individual data points). 
Section 9.0 
9.0 Statistical Considerations 
The statistical evaluation will be performed 
using SAS® software version 9.4 or higher 
(SAS Institute, Cary, NC). All data will be 
listed, and summary tables will be 
provided. No formal significance testing 
will be performed. Summary statistics will 
be presented by treatment group. 
9.0 Statistical Considerations 
The statistical evaluation will be performed 
using SAS® software version 9.4 or higher 
(SAS Institute, Cary, NC). All data will be 
listed, and summary tables will be 
provided. No formal significance testing 
will be performed. Summary statistics will 
be presented by treatment group and 
include subset analysis (eg, all subjects, 
seronegative subjects [ie, neutralizing 
antibody titer < 10 at screening], 
seropositive subjects, and subjects that 
received an FDA Emergency Use 
Authorization/licensed COVID vaccine). 
Addition of the subsets to be analyzed. 
Sections 9.6, 9.7, 9.8 
9.6 Immunogenicity Analysis 
In addition, if any subjects seropositive for 
SARS-CoV-2 are enrolled, safety and 
efficacy subgroup analysis will be 
performed for this group of subjects. 
9.6 Immunogenicity Analysis 
Subjects who are seropositive and 
seronegative at screening will also be 
summarized and safety and efficacy 
subgroup analysis will be performed for 
these groups of subjects. 
Additional details for analysis are 
presented in the SAP. 
Clarification that seropositive and 
seronegative screening status will be 
summarized and that safety and 
efficacy will be analyzed using these 
subgroups.  

KBP-201 Amendment 8 (Final Protocol v9.0, dated 12 November 2021) Updates in FDA Tabular Format 
Protocol Section(s) of Current 
Version (Final Protocol v9.0, 
12 November 2021) Affected by 
Change 
Previous Version (Final Protocol v8.0, 
28 June 2021) Example Text 
Current Version (Final Protocol v9.0, 
12 November 2021) Example Text 
Rationale 
Sections 7.6, 8.2.2 
7.6 SARS-CoV-2 Exposure and 
Asymptomatic Monitoring  
Subjects will be monitored for 
SARS-CoV-2 exposure for potential 
asymptomatic infection throughout the 
study. CRU staff will interview subjects 
about any potential exposure to the virus. 
If a subject has had potential exposure, the 
CRU will perform an unscheduled 
nasopharyngeal swab.  
7.6 SARS-CoV-2 Exposure and 
Asymptomatic Monitoring  
Subjects will be monitored for SARS-CoV-
2 exposure for potential asymptomatic 
infection throughout the study. CRU staff 
will interview subjects about any potential 
exposure to the virus. If a subject has had 
potential exposure, the CRU will perform 
an unscheduled nasopharyngeal swab. 
Subjects will not be discontinued from 
the study due to positive SARS-CoV-2 
test results. 
Reiterate that subjects will not be 
discontinued due to positive 
SARS-CoV-2 test. 
Section 9.8 
9.8 Safety Analysis 
In addition, if any subjects seropositive for 
SARS-CoV-2 are enrolled, safety and 
efficacy subgroup analysis will be 
performed for this group of subjects. 
9.8 Safety Analysis 
Subjects who are seropositive and 
seronegative at screening will also be 
summarized and safety and efficacy 
subgroup analysis will be performed for 
this group of subjects. 
Additional details for safety analysis are 
presented in the SAP. 
Clarification of analysis of 
seronegative and seropositive subjects. 

KBP-201 Amendment 8 (Final Protocol v9.0, dated 12 November 2021) Updates in FDA Tabular Format 
Protocol Section(s) of Current 
Version (Final Protocol v9.0, 
12 November 2021) Affected by 
Change 
Previous Version (Final Protocol v8.0, 
28 June 2021) Example Text 
Current Version (Final Protocol v9.0, 
12 November 2021) Example Text 
Rationale 
Study Administrative Structure 
Section 16 
Study Administrative Structure 
Sponsor’s Contact:  
Hugh Haydon 
President 
Kentucky BioProcessing, Inc. 
 
ELISA (IgM & IgG) and Cell Mediated 
Immunity Laboratory: 
ICON Central Laboratory 
123 Smith Street 
Farmingdale, NY 11735 USA 
Study Administrative Structure 
Sponsor’s Contact:  
Oscar (Tony) A. Guzman, MD, CP 
Clinical Project Lead 
Kentucky BioProcessing, Inc. 
 
ELISA (IgM & IgG) Antibody Titer and 
Cell Mediated Immunity Laboratories: 
VisMederi srl 
Strada del Petriccio e Belriguardo, 35, 
53100 Siena, Italia 
ICON Central Laboratory 
123 Smith Street 
Farmingdale, NY 11735 USA 
Change in Sponsor Contact and 
protocol signatory and inclusion of the 
laboratory performing the antibody 
titers. 
Additional updates performed include minor format updates and an update to the protocol version/date. 

 
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Clinical Study Protocol 
 
 
A Phase I/II, First-in-human, Observer-blinded, Randomized, Placebo-controlled, Parallel Group 
Study to Evaluate the Safety and Immunogenicity of TAP-COVID-19 SARS-CoV-2 Vaccine 
with CpG Adjuvant in Healthy Adults Aged 18-49 and 50-85 
 
Protocol Number: KBP-201 
 
 
Version 9.0  
Date: 12 November 2021 
 
Sponsor: 
Kentucky BioProcessing, Inc. 
3700 Airpark Drive 
Owensboro, KY 42301 USA 
Telephone: 270-689-2570 
Contract Research 
Organization: 
ICON Clinical Research, LLC 
820 West Diamond Avenue, Suite 100 
Gaithersburg, MD 20878 USA 
Telephone: 301-944-6800 
Fax: 215-699-6288 
 
 
 
Confidentiality Statement 
This document and the information contained herein or attached hereto ("Confidential Material") are confidential 
and proprietary to Kentucky BioProcessing, Inc. This Confidential Material should be viewed only by those 
individuals or companies that have been given prior authorization to do so by Kentucky BioProcessing, Inc. 
("Authorized Users"). This Confidential Material should not be made available in any form to any person or 
company, other than the Authorized Users and their respective employees or associates on a need-to-know basis, 
without the prior written consent from Kentucky BioProcessing, Inc.
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Kentucky BioProcessing, Inc. 
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Protocol Version 9.0 
 
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1 
SYNOPSIS 
Protocol Title: 
A Phase I/II, First-in-human, Observer-blinded, Randomized, Placebo-controlled, Parallel 
Group Study to Evaluate the Safety and Immunogenicity of TAP-COVID-19 SARS-CoV-2 
Vaccine with CpG Adjuvant in Healthy Adults Aged 18-49 and 50-85 
Study Phase: 
Phase I/II 
Objectives: 
Primary Objective: 
 
To assess the safety and reactogenicity of two doses of TAP-COVID-19 vaccine with 
Cytosine PhosphoGuanine (CpG) adjuvant for 7 days post vaccination compared with 
placebo as determined by solicited local and systemic reactogenicity 
Secondary Objectives: 
 
To compare the frequency of unsolicited adverse events (AEs) of each dose of 
TAP-COVID-19 vaccine with CpG adjuvant through Day 43 and serious adverse 
events (SAEs), medically attended adverse events (MAAEs), new onset chronic 
diseases (NOCDs), and adverse events of special interest (AESIs) through Day 365  
Comparisons include: 
o 
High dose (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG) to placebo 
o 
Low dose (15 μg TAP-COVID-19 vaccine + 0.5 mg CpG) to placebo 
o 
High dose (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG) to low dose 
(15 μg TAP-COVID-19 vaccine + 0.5 mg CpG) 
 
To evaluate the immunogenicity of TAP-COVID-19 vaccine with CpG adjuvant 
compared with placebo in terms of antibody assessed by geometric mean titers (GMTs) 
of both spike receptor binding domain (RBD) IgG and IgM antibodies and neutralizing 
antibody response, geometric mean fold rise (GMFR) in neutralizing titer from baseline 
in all treatment groups at Days 8, 22, 29, 43, 90, 181, 273, and 365 relative to baseline 
Exploratory Objectives: 
 
To assess cellular immunity by measuring the numbers of cytokine producing CD4+ 
and CD8+ T-cells from peripheral blood mononuclear cells (PBMCs) response to 
vaccine in all treatment groups at Days 8, 22, 29, 43, 90, 181, 273, and 365 compared 
to baseline  
 
To assess the immunogenicity of the RBD and Fc component of the vaccine 
Endpoints: 
Primary Endpoints: 
Occurrence of Solicited AEs: 
 
Solicited administration site reactions (eg, pain, tenderness, erythema/redness, 
induration/swelling) during the 7-day follow-up period after each vaccination (Day 1-8 
and Day 22-29) 
 
Solicited systemic events (eg, fever, nausea/vomiting, diarrhea, headache, fatigue, 
myalgia) during the 7-day follow-up period after each vaccination (Day 1-8 and 
Day 22-29) 
Secondary Endpoints: 
Safety: 
 
Unsolicited AEs, MAAEs, and AESIs up to Day 43  
 
SAEs, MAAEs, NOCDs, and AESIs up to Day 365 (approximately 1 year after first 
vaccination) 
Immunogenicity: 
Vaccine enzyme-linked immunosorbent assay of both spike receptor binding domain (RBD) 
IgG and IgM antibodies and neutralizing antibody titers for each treatment group: 
 
GMT at baseline and Days 15, 22, 43, 90, 181, 273, and 365 
 
GMT ratio (GMTplacebo/GMTTAP-COVID-19) at baseline and Days 22, 29, 43, 90, 181, 273, 
Deleted: receptor binding domain (
Deleted: )
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and 365 
 
GMFR at Days 8, 22, 29, 43, 90, 181, 273, and 365 relative to baseline 
 
Seroconversion rates on Days 8, 15, 22, 29, 43, 90, 181, 273, and 365. Seroconversion 
is defined as the proportion of subjects at the respective time point that have detectable 
antibodies (IgG and IgM) against SARS-CoV-2 Spike Protein RBD following 
challenge with vaccine (and potentially by natural asymptomatic or symptomatic 
infection by the virus in case of a placebo subject). 
 
Geometric mean increase (GMI) on Days 8, 22, 29, 43, 90, 181, 273, and 365 
Exploratory Endpoints: 
Cellular immunity: 
 
The number of cytokine producing CD4+ and CD8+ T-cells from PBMCs responsive 
to vaccine antigens in all treatment groups on Days 8, 22, 29, 43, 90, 181, 273, and 365 
compared to baseline  
Immunogenicity: 
 
Anti-RBD and anti-Fc antibodies at baseline and Days 8, 15, 22, 29, 43, 90, 181, 273, 
and 365 
Study Design: 
This is a first-in-human (FIH), observer-blinded, randomized, placebo-controlled, parallel 
group study to evaluate the safety and immunogenicity of TAP-COVID-19 vaccine with 
CpG adjuvant in healthy adult subjects in 2 age groups, Part A (18-49 years) and Part B 
(50-85 years). A study schematic is presented in Figure 4-1. 
PART A and PART B: 
Subjects will be screened up to 14 days (Day -14 to Day -1) before randomization. Overall, 
approximately 90 eligible healthy adults ages 18-49 years (inclusive) will be enrolled for 
Part A and 90 eligible healthy adults ages 50-85 years will be enrolled for Part B.  
Sentinel dosing will be utilized in this FIH study. Sentinel cohorts will be used for the 
following groups:  
⁃ 
Part A (18-49 years) low dose (15 μg TAP-COVID-19 vaccine + 0.5 mg CpG)  
⁃ 
Part B (50-85 years) low dose (15 μg TAP-COVID-19 vaccine + 0.5 mg CpG)  
⁃ 
Part A (18-49 years) high dose (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG)  
⁃ 
Part B (50-85 years) high dose (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG)  
Three sentinel subjects from each part will be randomized 2:1 (active:placebo). The 
independent Safety Review Committee (iSRC) will review the safety and tolerability data 
for the sentinel subjects through Day 8 prior to enrollment of the remaining cohort subjects 
randomized 2:1 (active:placebo).  
When all subjects in Part A (18-49 years) low dose have received the first vaccination and 
have all safety data through Day 8, the iSRC will convene and review the safety data to 
ensure that there are no safety concerns and that none of the Study Halting Rules have been 
met before recommending that the study enroll Part A high dose and Part B (50-85 years) 
low dose.  
When all subjects in Part B (50-85 years) low dose have received the first vaccination and 
have all safety data through Day 8, the iSRC will convene and review the safety data to 
ensure that there are no safety concerns and that none of the Study Halting Rules have been 
met before recommending that the study enroll Part B high dose. 
The iSRC will convene and review the safety data when a minimum of 23 subjects have 
completed Day 29 after the second vaccination for Part A (low and high dose) and for Part B 
(low and high dose) to ensure that there are no concerns. 
Both Part A (18-49 years) and Part B (50-85 years) will be randomized in a 2:1 ratio 
(active:placebo) for each treatment dose (15 μg and 45 μg TAP-COVID-19 vaccine + 0.5 mg 
CpG) for a total of 90 subjects per Part (30 subjects 15 μg TAP-COVID-19 vaccine + 0.5 mg 
CpG:30 subjects 45 μg TAP-COVID-19 vaccine + 0.5 mg CpG:30 subjects placebo). 
Treatment A: TAP-COVID-19 vaccine (15 μg) + CpG (0.5 mg) intramuscular (IM) injection 
Deleted: -
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on Day 1 and Day 22 (±3 days) 
Treatment B: TAP-COVID-19 vaccine (45 μg) + CpG (0.5 mg) IM injection on 
Day 1 and Day 22 (±3 days) 
Treatment C: Placebo (buffered saline solution) IM injection on Day 1 and Day 2 
(±3 days) 
Study vaccine will be prepared by an unblinded site pharmacist and administered at the 
clinical research site on Day 1 and Day 22 (±3 days) by unblinded clinical research unit 
(CRU) personnel. Subjects will be observed for immediate AEs and/or reactogenicity for 
approximately 60 minutes after administration of vaccine. Subjects will be provided with a 
Diary Card and will be trained to record specifically elicited systemic and local symptoms 
daily as well as any additional AEs during the 7-day follow-up period after each vaccination. 
Visits will be conducted at the clinical site on an outpatient basis or as a telephone visit per 
the Schedule of Assessments and Procedures. Subjects will participate in the study for 
approximately 1 year from the first dose. 
AEs and concomitant medications will be captured through Day 43. Blood and serum 
samples for safety laboratory tests, RBD IgG and IgM antibodies and neutralizing antibody 
titers, cell-mediated immunity, and other future biomedical research will be obtained at 
baseline and before administration of vaccine dose 2 and after each vaccination per the 
Schedule of Assessments and Procedures. SAEs, MAAEs, NOCDs, and AESIs only will be 
captured after Day 43 to study completion (Day 365 [approximately 1 year after first 
vaccination]).  
Prior to receiving a second dose of vaccine, subjects will have the following assessments 
performed to ensure eligibility: vital signs (including temperature), review of clinical 
laboratory test results to date, nasopharyngeal swab Day 15 to check for SARS-CoV-2 
infection (reverse transcription polymerase chain reaction [RT-PCR] result must be received 
by the CRU and negative prior to the second vaccine administration), medical history since 
last visit including AE assessment for SAEs, Grade 3 AEs, or AESIs that are possibly, 
probably, or definitely related to study vaccine without a plausible alternative explanation, 
targeted physical examination, recheck of eligibility criteria, and pregnancy test (as 
applicable). 
Subjects will be monitored for SARS-CoV-2 exposure for potential asymptomatic infection 
throughout the study.  
 
If a subject has a positive or borderline ELISA anti-N IgG result, sites should have the 
subject return for an unscheduled PCR. If the ELISA is positive and the PCR is 
negative, the sites should follow the subjects using the standard of care under 
Investigator discretion, retesting ELISA at the next study visit(s) or sooner (per the 
Investigator’s decision). 
 
If the subject has a positive or borderline ELISA anti-N IgG AND a positive PCR test, 
the clinical sites should bring the subjects back for repeat PCR testing as described 
below. 
 
The clinical sites should continue to collect PCR tests if a subject is experiencing 
possible COVID-19 symptoms, or had possible exposure to SARS-CoV-2 (ie, close 
contact tests positive for SARS-CoV-2). Testing will occur every 2 weeks for a total of 
4 weeks (if 2 consecutive negative tests) or until negative (x2) after a positive result. 
Positive results will be reported as an AESI and subjects followed for disease severity, 
duration, and outcome. 
Subjects who are seropositive for SARS-CoV-2 and asymptomatic will be allowed to enroll 
into Parts A and B of the study as long as the subject is RT-PCR negative. 
Interim Safety Data Reviews: 
For all of the sentinel groups, the iSRC will meet to review the sentinel subjects’ safety and 
tolerability data through Day 8. In the event that iSRC has not met for the post Day 8 review 
because the entire sentinel group (n = 3) has not completed Day 8 before a sentinel subject 
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is to receive the second vaccine on Day 22, the iSRC will meet on an ad hoc basis, to ensure 
there are no safety concerns and that none of the Individual Discontinuation Criteria or Study 
Halting Rules have been met, prior to the sentinel subjects receiving the second vaccine. 
When all subjects in Part A (18-49 years) low dose have received the first vaccination and 
have all safety data through Day 8, the iSRC will convene and review the safety data to 
ensure that there are no safety concerns and that none of the Study Halting Rules have been 
met before recommending that the study enroll Part A high dose and Part B low dose. The 
same strategy will be used for Part B when going from low to high dose.  
The iSRC will be asked to review unblinded immunogenicity and safety data when the first 
30 subjects vaccinated in the Part A low dose group (including active and placebo subjects) 
have data available from Day 1 through Day 43 for an assessment of the risk-benefit of the 
trial.  
The iSRC will also meet when a minimum of 23 subjects have completed Day 29 after the 
second vaccination for Part A (low and high dose) and for Part B (low and high dose) to 
review safety data to ensure that there are no concerns. 
The iSRC will also review all data through Day 43 for Part A and for Part B in both dose 
groups to monitor for ongoing safety concerns and immunogenicity analysis. When the Parts 
A and B Day 43 (low and high dose) review is complete, the iSRC will recommend a dose 
for the Part C Expansion (optional). Progression to Part C will only take place after the 
Center for Biologics Evaluation and Research (CBER) has had the opportunity to review the 
Day 43 data from Parts A and B and concurs with the plan to proceed with enrollment. 
Study Halting Rules: 
The occurrence and confirmation of 1 or more of the following findings will result in 
suspension of further enrollment and study vaccine administration pending urgent review 
(within 1 week) of the safety data by the iSRC. Subjects who are withdrawn from study 
vaccine (if applicable) will continue to be monitored for safety and immunogenicity. 
 
One or more subjects experience an SAE assessed as possibly related, probably related, 
or related to study vaccine without a plausible alternative explanation. 
 
One or more subjects have generalized urticaria during the 7-day post vaccination 
period. 
 
One or more subjects develop a Grade 4 local reaction for which there is no alternative 
plausible explanation.  
 
One or more subjects experience laryngospasm, bronchospasm, or anaphylaxis after 
vaccine administration considered related to the vaccine.  
 
One or more subjects develop a fever >40°C/104°F during the 7 days post vaccination 
period that is assessed as possibly related, probably related, or related to study vaccine 
without a plausible alternative explanation. 
 
Two or more subjects within an individual treatment group, or 2 or more subjects across 
treatment groups, experience any Grade 3 or higher abnormality in the same laboratory 
parameter determined by the Investigator or medical monitor as clinically significant 
and that are assessed as possibly related, probably related, or related to study vaccine 
without a plausible alternative explanation.  
 
Two or more subjects across treatment groups experience a Grade 3 or higher AE, 
MAAE, or AESI of the same or similar preferred terms (as categorized by the Medical 
Dictionary for Regulatory Activities [MedDRA]) assessed as possibly related, probably 
related, or related to study vaccine without a plausible alternative explanation. 
 
Any subject with severe SARS-CoV-2 infection will be assessed for the possibility of 
vaccine-associated enhanced respiratory disease. Severe SARS-CoV-2 infection is 
defined as individuals who have virologically confirmed SARS-CoV-2 infection with 
any of the following: 
o 
Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30 
breaths per minute, heart rate ≥ 125 bpm, oxygen saturation (SpO2) ≤ 93% on room 
Deleted: The remaining study cohorts will have an unblinded 
immunogenicity and safety data review when all subjects in the 
cohort have data available from Day 1 through Day 43. 

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air at sea level or partial pressure of oxygen/ fraction of inspired oxygen 
(PaO2/FiO2) < 300 mmHg) 
o 
Respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, 
mechanical ventilation or extracorporeal membrane oxygenation [ECMO]) 
o 
Evidence of shock (systolic blood pressure < 90 mmHg, diastolic blood pressure 
< 60 mmHg, or requiring vasopressors) 
o 
Significant acute renal, hepatic, or neurologic dysfunction 
o 
Admission to an intensive care unit (ICU) 
o 
Death due to SARS-CoV-2 infection 
The iSRC will review unblinded safety data for any subject who dies, requires ICU 
admission due to SARS-CoV-2 infection, develops an AESI of autoimmune disease or 
potential immune-medicated medical condition, or experiences vaccine-associated enhanced 
respiratory disease. If the subject had received TAP-COVID-19, the iSRC may decide 
whether a study halt for vaccine-enhanced disease is required based on a review of all 
available clinical and preclinical safety and immunogenicity data. 
 
PART C EXPANSION (OPTIONAL): 
The Part C Expansion may be conducted to confirm the safety and immunogenicity of a 
selected dose across the broad target age span using a larger sample size. The proposed 
sample size was selected based on World Health Organization (WHO) guidelines on clinical 
evaluation of vaccines: regulatory expectations Annex I (2001), which states that 
approximately 300 subjects are needed to identify common local reactogenicity events. A 
larger sample size will assist in a better characterization of kinetics and range of immunity 
(neutralizing antibody titers) and provide a more reliable output of seropositivity and 
seroconversion to TAP-COVID-19 immunization. With the limited clinical experience with 
SARS-CoV-2 vaccines and the current lack of a biomarker correlate of protection, the 
generation of this larger data set is relevant to inform the design and implementation of a 
Phase 3 program. After review of safety and immunogenicity data from Parts A and B 
through Day 43, a dose for the Phase II expansion study will be recommended by the iSRC. 
Progression to Part C will only take place after CBER has had the opportunity to review the 
human clinical plus additional nonclinical data and concurs with the plan to proceed with 
enrollment. Subjects ≥18 years of age will be enrolled and randomized 1:1 (selected active 
dose:placebo). Up to 1000 subjects will be enrolled at the chosen dose to provide expanded 
dose confirmation, safety, and immunogenicity data. Although all subjects in Part C will 
have safety laboratory tests performed at screening, only the first 200 subjects in Part C will 
have safety laboratory tests performed at all post-dose time points. The remaining subjects 
in Part C will not have safety laboratory tests performed at any of the post-dose time points 
unless the Investigator deems it necessary. 
Subjects who are seropositive for SARS-CoV-2 and asymptomatic will be allowed to enroll 
into Part C of the study. 
Study Rationale: 
Multiple vaccines have been approved for emergency use for the prevention of 
SARS-CoV-2, with other vaccines close to being available either through emergency use or 
licensed vaccines. Although work continues on antiviral treatments for SARS-CoV-2, given 
the crisis of COVID-19 infections in the world, the fast expansion to the United States and 
other parts of the world, and the global push to vaccinate everyone, additional sources of 
effective vaccine will be needed. 
Subject Selection 
Criteria: 
Inclusion Criteria: 
Subjects must meet all inclusion criteria to be eligible for study participation. In addition, 
racial and ethnic minorities will be sought to obtain a diverse study population. 
All Subjects 
1. Subject read, understood, and signed the informed consent form (ICF).  
2. Healthy adult males and females 18-49 years of age (Part A) or 50-85 years of age 
(Part B), inclusive, at screening. 

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3. RT-PCR negative at time of screening  
4. Body 
mass 
index 
(BMI) 
of 
≥ 
18 
and 
≤ 
30 
kg/m2 
at 
screening. 
BMI = weight (kg)/(height [m])2. 
5. Must be in general good health before study participation with no clinically relevant 
abnormalities that could interfere with study assessments.  
6. Women of childbearing potential (WOCBP) and men whose sexual partners are 
WOCBP must be able and willing to use at least 1 highly effective method of 
contraception (ie, include hysterectomy, bilateral salpingectomy, and bilateral 
oophorectomy, hormonal oral [in combination with male condoms with spermicide], 
transdermal, implant, or injection, barrier [ie, condom, diaphragm with spermicide]; 
intrauterine device; vasectomized partner [6 months minimum], clinically sterile 
partner; or abstinence) during the study.  
 
A female subject is considered to be a WOCBP after menarche and until she is in 
a postmenopausal state for 12 consecutive months (without an alternative medical 
cause) or otherwise permanently sterile.  
 
Note: Subjects not of childbearing potential are not required to use any other forms 
of contraception during the study. Non-childbearing potential is defined as subject 
confirmed:  
o Surgical sterilization (eg, bilateral oophorectomy, bilateral salpingectomy, 
bilateral occlusion by cautery [Essure System is not acceptable], 
hysterectomy, or tubal ligation).  
o Postmenopausal (defined as permanent cessation of menstruation for at least 
12 consecutive months prior to screening) with follicle-stimulating hormone 
≥ 30 mIU/mL at screening. 
7. WOCBP must have a negative urine pregnancy test before each vaccination. 
8. Must be able to attend all visits, including unscheduled visits if respiratory symptoms 
suggestive of SARS-CoV-2 infection develop during the study, for the duration of the 
study and comply with all study procedures, including daily completion of the Diary 
Card for 7 days after each injection. 
Exclusion Criteria: 
Subjects will not be eligible for study participation if they meet any of the exclusion criteria, 
or will be discontinued at the discretion of the Investigator if they develop any of the 
exclusion criteria during the study.  
Parts A and B 
1. History of an acute or chronic medical condition including dementia that, in the opinion 
of the Investigator, would render vaccination unsafe or would interfere with the 
evaluation of responses. Chronic conditions that are NOT included on the Center for 
Disease Control’s list of subjects at higher risk for severe illness from SARS-CoV-2 are 
acceptable if the condition has been stable for the 3 months prior to vaccine 
administration (Day 1), with no medication changes, and no hospitalization in the past 
6 months. 
2. History of any medical conditions that place subjects at higher risk for severe illness due 
to SARS-CoV-2 including but not limited to cancer, chronic kidney disease at any stage, 
chronic lung disease, dementia or other neurological conditions, diabetes (Type 1 or 
Type 2), Down syndrome, heart conditions, human immunodeficiency virus (HIV) 
infection, immunocompromised state (weakened immune system), liver disease, 
overweight/obesity, pregnancy, sickle cell disease or thalassemia, smoker (current or 
former), transplants (solid organ or blood stem cell), stroke or cerebrovascular disease, 
and substance use disorders.  
3. History of ongoing clinical condition or medication or treatments that may adversely 
affect the immune system. 
 

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4. Individuals who are RT-PCR positive for SARS-CoV-2 at screening or prior to second 
dose of TAP-COVID-19 vaccine. 
5. Individuals who are at increased risk of exposure to SARS-CoV-2 (eg, healthcare 
workers, emergency responders). 
6. Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to 
vaccine administration. 
7. Living in a group care facility (eg, assisted living or nursing home). 
8. Individuals with any elevated (Grade 1 or higher) laboratory test assessed as clinically 
significant for age by the Investigator at screening. 
9. Individuals with elevated (Grade 1 or higher) liver function enzyme at screening, may 
repeat testing once to re-assess clinical significance. If the retest comes back within 
normal range, the subject will be eligible for enrollment with Investigator and Medical 
Monitor approval. See below for the criteria for excluding subjects with elevated liver 
enzymes (once confirmed by retest): 
 
Alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate 
aminotransferase (AST), or gamma-glutamyl transferase (GGT) >1.5 × upper limit 
of normal (ULN) 
 
Total bilirubin >1.6 × ULN 
10. Active neoplastic disease (excluding nonmelanoma skin cancer that was successfully 
treated) or a history of any hematological malignancy. “Active” is defined as having 
received treatment within the past 5 years. 
11. Long-term (greater than 2 weeks) use of oral or parenteral steroids, high-dose inhaled 
steroids (>800 μg/day of beclomethasone dipropionate or equivalent), or 
immunomodulatory drugs within 6 months before screening (nasal and topical steroids 
are allowed). 
12. History of autoimmune, inflammatory disease, or potential immune-mediated medical 
conditions (Appendix B). 
13. Women currently pregnant, lactating, or planning a pregnancy between enrollment and 
181 days after randomization. 
14. History of Guillain-Barré Syndrome.  
15. History of anaphylactic-type reaction to injected vaccines.  
16. Known or suspected hypersensitivity to 1 or more of the components of the vaccine, 
including thimerosal, tobacco, and CpG adjuvant.  
17. History of alcohol abuse, illicit drug use, physical dependence to any opioid, or any 
history of drug abuse or addiction within 12 months of screening. 
Note: In those regions where cannabis use is legal, it will be left to the discretion of the 
Investigator to decide if a subject is an occasional user or an abuser of cannabis. The 
Investigator should discuss user/abuser status on a case-by-case basis with the Medical 
Monitor prior to enrollment. 
18. Acute illness or fever within 3 days before study enrollment (enrollment may be delayed 
for full recovery if acceptable to the Investigator).  
19. Individuals currently participating or planning to participate in a study that involves an 
experimental agent (vaccine, drug, biologic, device, or medication); or who have 
received an experimental agent within 1 month (3 months for immunoglobulins) before 
enrollment in this study; or who expect to receive another experimental agent during 
participation in this study. 
20. Receipt of immunoglobulin or another blood product within the 3 months before 
enrollment in this study or those who expect to receive immunoglobulin or another blood 
product during this study.  
21. Individuals who intend to donate blood within 6 months after the first vaccination.  
22. Individuals using prescription medications for prophylaxis of SARS-CoV-2. 

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23. Individuals who plan to receive another vaccine within the first 3 months of the study 
except influenza vaccine which should not be given within 2 weeks of study vaccine.  
24. Receipt of any other approved SARS-CoV-2 vaccine prior to the first study vaccine or 
within 90 days after administration of the first study vaccine. 
25. Receipt of any other experimental coronavirus vaccine at any time prior to or during the 
study.  
26. Receipt of any investigational vaccine or drug within 1 month of enrollment and through 
the end of the study (1 year after first vaccination). 
27. Plan to travel outside the subjects’ country of residence from enrollment through 
Day 43.  
28. History of surgery or major trauma within 12 weeks of screening, or surgery planned 
during the study. 
29. Significant blood loss (>450 mL) or has donated 1 or more units of blood or plasma 
within 6 weeks prior to study participation. 
30. Strenuous activity (as assessed by the Investigator) within 48 hours prior to dosing 
(Days 1 and 22). 
31. A positive urine drug screen without evidence of corresponding prescribed concomitant 
medication(s) at Screening. Note: A positive drug screen result with a corresponding 
prescribed concomitant medication will be allowed if, in the opinion of the investigator 
and Medical Monitor, the concomitant medication does not make the subject unsuitable 
to participate in the clinical trial. For a positive tetrahydrocannabinol result, refer to 
Exclusion Criteria #17. 
32. Positive alcohol screen. 
33. Positive screen for HIV-1 and HIV-2 antibodies, hepatitis B surface antigen (HBsAg), 
or hepatitis C virus (HCV) antibody. 
34. Involved in the planning or conduct of this study. 
35. Unwilling or unlikely to comply with the requirements of the study. 
36. Subject is an employee, contractor, friend of or relative of any employee of Sponsor, 
contract research organization (CRO), study site or site affiliate. 
Part C 
If the study proceeds to the Part C Expansion study, the following exclusion criteria 
(Number, from Parts A and B) will be not applicable. 
(5) Individuals who are at increased risk of exposure to SARS-CoV-2 (eg, healthcare 
workers, emergency responders). 
(6) Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior 
to vaccine administration. 
(7) Living in a group care facility (eg, assisted living or nursing home). 
(31) A positive urine drug screen without evidence of corresponding prescribed 
concomitant medication(s) at Screening. Note: A positive drug screen result with a 
corresponding prescribed concomitant medication will be allowed if, in the 
opinion of the investigator and Medical Monitor, the concomitant medication does 
not make the subject unsuitable to participate in the clinical trial.  
(32) Positive alcohol screen. 
(33) Positive screen for HIV-1 and HIV-2 antibodies, HBsAg, or HCV antibody (Parts A 
and B). For Part C, subjects known to be HIV positive or have active Hepatitis B or 
C infection will be excluded.  
Study Vaccine, Dose, 
and 
Route 
of 
Administration: 
TAP-COVID-19: 0.5 mL of TAP-COVID-19 vaccine at 15 μg or 45 μg + CpG (0.5 mg), 
administered by IM injection on Day 1 and Day 22 (±3 days). 

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Reference 
Vaccine, 
Dose and Route of 
Administration: 
Placebo: 0.5 mL buffered saline solution, administered by IM injection on Day 1 and Day 22 
(±3 days). 
Planned Sample Size: No formal sample size calculation was performed.  
A total of 180 subjects will be enrolled in Parts A and B. Approximately 90 eligible subjects 
(aged 18-49 years), with 30 subjects per treatment group for Part A and 90 eligible subjects 
(aged 50-85 years), with 30 subjects per treatment for Part B, will be enrolled in the study.  
An optional Part C Expansion may be conducted to confirm the safety and immunogenicity 
of the selected dose of vaccine in up to 1000 adult subjects randomized 1:1 (single dose level 
of study vaccine:placebo). The proposed sample size was selected based on WHO guidelines 
on clinical evaluation of vaccines: regulatory expectations Annex I (2001), which states that 
approximately 300 subjects are needed to identify common local reactogenicity events. A 
larger sample size will assist in a better characterization of kinetics and range of immunity 
(neutralizing antibody titers) and provide a more reliable output of seropositivity and 
seroconversion to TAP-COVID-19 immunization. With the limited clinical experience with 
SARS-CoV-2 vaccines and the current lack of a biomarker correlate of protection, the 
generation of this larger data set is relevant to inform the design and implementation of a 
Phase 3 program. 
Statistical Analysis: 
Analysis Populations:  
Enrolled Population: All subjects who signed the ICF.  
Safety Population: All subjects who provided consent, are randomized, and received any 
amount of study vaccine/placebo. The Safety Population will be used for the demographic, 
baseline characteristic, safety data summaries, and the analysis of primary endpoints such as 
occurrence of solicited local and systemic reactogenicity. 
Per Protocol (PP) Population: Includes all subjects in the Safety Population who receive the 
assigned doses of the study vaccine/placebo according to protocol, have serology results, 
and have no major protocol deviations affecting the primary immunogenicity outcomes, as 
determined by the Sponsor before database lock and unblinding. Subjects that are immunized 
with an approved vaccine will be captured as a subset analysis of the PP Population at 
Days 90, 181, 273, and 365 based on the date of receiving an approved COVID-19 vaccine. 
Modified Intent-to-Treat (mITT) Population: Includes all subjects in the Safety Population 
who provide any serology data. The mITT Population will be used for immunogenicity 
analysis.  
Immunogenicity Analysis: 
The mITT Population will be used for all listings and summary statistics corresponding to 
immunogenicity analysis.  
The individual sampling and blood collection for ELISA analysis to determine IgG and IgM 
antibody titers to the spike RBD and neutralizing antibody titers for parent (Wuhan) and any 
variant SARS-CoV-2 strains, will be listed and summarized by time points for each part by 
treatment.  
All derived immunogenicity secondary endpoint parameters: GMT, GMT ratio, GMFR, 
GMI, and seroconversion rates will be listed and summarized by scheduled time point using 
descriptive statistics (n, mean, standard deviation, minimum, median, maximum, geometric 
mean, coefficient of variation (percentage) (CV%), geometric coefficient of variation 
(percentage) (GeoCV%), and 95% confidence interval) for each part by treatment. 
PBMC and serum sample data for future research results at each scheduled visit will also be 
provided separately in a listing and summary table, if applicable. 
Graphical display of the summary results or at individual time points will be provided as 
needed (eg, scatter plots of subject titer values to visually display individual data points). 
 
 
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failures and all subjects who are discontinued from the study prior to 
study vaccine administration and will be used for disposition 
summaries.
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Cellular Analysis: 
The number of IFN- and IL-5 producing T-cells (CD4+ and CD8+) from PBMCs 
responsive to vaccine antigens will be listed and summarized by time point using appropriate 
descriptive statistics for each part by treatment. 
Safety Analysis:  
Safety Population will be used for all safety variables specified.  
All safety data will be summarized by part and treatment. No statistical tests will be 
performed. 
In addition, if any subjects seropositive for SARS-CoV-2 are enrolled, safety and efficacy 
subgroup analysis will be performed for this group of subjects. 
 
 
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1.1 
Schedule of Assessments and Procedures 
Table 1-1 
Schedule of Assessments and Procedures 
Study Visit SCR Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 
Visit 8 
Visit 9 
Visit 10 Visit 11 Visit 12 
Visit 13 
Study  
End 
UNSCH
/ET 
Study Day 
(Visit 
Window) 
 
Procedures 
Day  
-14  
to  
Day -1 Day 1 
Day 8  
(±1 
Day) 
Day 
15  
(±1 
Day) 
Day 
22 (±3 
Days) 
Day 
29 
(±2 
Days) 
Day 
43 (±2 
Days) 
Day 76  
(±3 
Days) 
Day 90  
(±14 
Days) 
Day 120 
(±3 
Days) 
Day 150 
(±3 
Days) 
Day 181 
(±14 
Days) 
Day 273 
(±14 
Days) 
Day 365 
(±14 
Days) 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eligibility 
X 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Medical history 
X 
X a 
X a 
X a 
X a 
X a 
X a 
 
X a 
 
 
X a 
X a 
X a 
X a 
Demographic and 
baseline 
characteristics b 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Complete physical 
examination 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Targeted physical 
examination c 
 
X 
X 
X 
X 
X 
X 
 
 
 
 
X 
 
 
X 
Height, weight, BMI 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vital sign 
measurements d 
X 
X d 
X 
X 
X d 
X 
X 
 
X 
 
 
X 
X 
X 
X 
Urine pregnancy test e 
X 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Urine drug screen f 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HIV-1/2, HBsAg, 
HCV g 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Nasopharyngeal swab 
for RT-PCR h 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
X 
Serostatus  
(IgM & IgG) for 
SARS-CoV-2 q 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Oral Temperature 
(pre-vaccination) 
 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 

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Study Visit SCR Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 
Visit 8 
Visit 9 
Visit 10 Visit 11 Visit 12 
Visit 13 
Study  
End 
UNSCH
/ET 
Study Day 
(Visit 
Window) 
 
Procedures 
Day  
-14  
to  
Day -1 Day 1 
Day 8  
(±1 
Day) 
Day 
15  
(±1 
Day) 
Day 
22 (±3 
Days) 
Day 
29 
(±2 
Days) 
Day 
43 (±2 
Days) 
Day 76  
(±3 
Days) 
Day 90  
(±14 
Days) 
Day 120 
(±3 
Days) 
Day 150 
(±3 
Days) 
Day 181 
(±14 
Days) 
Day 273 
(±14 
Days) 
Day 365 
(±14 
Days) 
 
Vaccination dose 
(IM) 
 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
60 minute 
post-vaccination 
monitoring (arm 
check, VS, and 
targeted PE if general 
symptoms present) 
 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Distribution and 
training on Diary 
Card completion 
 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Review of  
Diary Card i 
 
 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
Telephone visit j 
 
 
 
 
 
 
 
X 
 
X 
X 
 
 
 
 
SARS-Cov-2 
exposure and 
asymptomatic 
monitoring k 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Adverse events l 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
SAEs, MAAEs, 
NOCDs and AESIs m 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Prior and concomitant 
medications n 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Clinical safety 
laboratory tests o 
X 
 
X 
X 
X 
 
X 
 
 
 
 
X 
 
 
X 
Blood collection for 
ELISA IgM and IgG 
total antibodies p 
X 
 
X 
X 
X 
X 
X 
 
X 
 
 
X 
X 
X 
X 

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Study Visit SCR Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 
Visit 8 
Visit 9 
Visit 10 Visit 11 Visit 12 
Visit 13 
Study  
End 
UNSCH
/ET 
Study Day 
(Visit 
Window) 
 
Procedures 
Day  
-14  
to  
Day -1 Day 1 
Day 8  
(±1 
Day) 
Day 
15  
(±1 
Day) 
Day 
22 (±3 
Days) 
Day 
29 
(±2 
Days) 
Day 
43 (±2 
Days) 
Day 76  
(±3 
Days) 
Day 90  
(±14 
Days) 
Day 120 
(±3 
Days) 
Day 150 
(±3 
Days) 
Day 181 
(±14 
Days) 
Day 273 
(±14 
Days) 
Day 365 
(±14 
Days) 
 
Blood collection for 
neutralizing, anti-
RBD, and anti-Fc 
antibodies 
X 
 
X 
X 
X 
X 
X 
 
X 
 
 
X 
X 
X 
X 
Cell-mediated 
immunity (PBMC) 
X 
 
X 
 
X 
X 
X 
 
X 
 
 
X 
X 
X 
X 
PBMC and serum 
sample collection for 
future research 
X 
 
X 
 
X 
X 
X 
 
X 
 
 
X 
X 
X 
X 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; BMI = body mass index; CRU = clinical research unit; ELISA = enzyme-linked 
immunosorbent assay; ET = Early Termination visit; HBsAg = hepatitis B surface antigen; HCV = hepatitis C virus; HIV = human 
immunodeficiency virus; Ig = immunoglobulin; IM = intramuscular; MAAE = medically attended adverse event; NOCD = new-onset chronic 
disease; PBMC = peripheral blood mononuclear cells; PE = physical examination; RBD = receptor binding domain; RT-PCR = reverse 
transcription polymerase chain reaction; SAE = serious adverse event; SCR = Screening visit; UNSCH = Unscheduled visit; VS = vital signs  
a. 
Medical history will be collected to determine if any changes have occurred since last visit. 
b. Baseline characteristics include tobacco use and history. 
c. 
Post vaccination targeted physical examination includes evaluation of any system indicated by an AE complaint. 
d. Pre-dose and approximately 60 minutes post vaccination. Vital signs will be measured after the subject has been resting quietly in a seated position for at 
least 5 minutes. Vital signs measurements will include blood pressure, heart rate, respiratory rate, and oral temperature. 
e. 
A negative urine pregnancy test must be documented before vaccination on Day 1 and Day 22 for women of childbearing potential. A serum pregnancy test 
must be performed to confirm any positive urine pregnancy test. 
f. 
For Parts A and B, a positive urine drug screen without evidence of corresponding prescribed concomitant medication(s) at Screening is exclusionary. A 
positive drug screen result with a corresponding prescribed concomitant medication will be allowed if, in the opinion of the Investigator and Medical 
Monitor, the concomitant medication does not make the subject unsuitable to participate in the clinical trial. 
g. Not performed for Part C. 
h. Serial nasopharyngeal swabs (RT-PCR) will be performed on subjects that report either potential exposure to SARS-CoV-2 (ie, close contact tests positive 
for SARS-CoV-2) or symptoms of SARS-CoV-2 infection. Testing will occur every 2 weeks for a total of 4 weeks (if 2 consecutive negative tests) or until 
negative after a positive result. Positive results will be reported as an AESI (Section 8.2.2) and subjects followed for disease severity, duration, and outcome. 
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i. 
Review of Diary Card (Appendix A) will include a check that the Diary Card has been completed appropriately and re-training the subjects, if necessary. 
Any illogical entries will be queried by the site and corrected if appropriate. 
j. 
During telephone visits, CRU staff will interview the subjects about any potential exposure to the virus. If a subject has had potential exposure, the CRU will 
ask the subject to come in for an unscheduled visit which will include a nasopharyngeal swab. Subjects will be reminded to contact the clinical site any time 
there is potential exposure to SARS-CoV-2. 
k. Subjects will be monitored for SARS-CoV-2 exposure for potential asymptomatic infection throughout the study. CRU staff will interview subjects about 
any potential exposure to the virus. If a subject has had potential exposure, the CRU will perform an unscheduled nasopharyngeal swab. 
l. 
Adverse events include questioning regarding the specifically elicited events on the Diary Card and complaints spontaneously reported in response to 
nondirective questions. 
m. SAEs, MAAEs, NOCDs, and AESIs will be collected from Day 1 through Day 365/approximately 1 year after first vaccination. 
n. Includes all medications taken during the first 43 days of the study, including those started 30 days before and ongoing at vaccination. 
o. Refer to Table 7-1 for a detailed list of clinical laboratory test parameters. Clinical laboratory tests can be repeated once at screening to confirm an 
out-of-range result. If Part C Expansion (optional) is performed, safety laboratory tests will be performed at screening for all Part C subjects in order to 
satisfy the inclusion/exclusion criteria. In addition, the first 200 subject in Part C will have safety laboratory tests performed at all time points. The remaining 
subjects in Part C will not have safety laboratory tests performed at any of the post-dose time points unless the Investigator deems it necessary.  
p. Subjects with positive ELISA anti-N IgG results without COVID-19 symptoms may indicate asymptomatic SARS-CoV-2 infection and will be followed 
appropriately. Subjects with a positive ELISA anti-N IgG result should have a PCR test and be followed until both are negative as in the protocol instructions 
(Section 7.6). 
q. Serostatus will not be used to determine eligibility; however, subjects with a positive serostatus for SARS-CoV-2 will have safety and efficacy subgroup 
analysis performed. 
NOTE: In the event multiple post-dose procedures are required to be conducted at the same nominal time point, the timing of antibody titer and cellular 
immunity blood sample collections will take priority over all other scheduled activities. In practice, the following order is recommended: (1) vital signs 
measurements; (2) antibody titer and cellular immunity blood sampling; (3) clinical laboratory tests sampling; (4) physical examination and height and 
body weight measurements. Vital signs may be conducted up to 10 minutes, prior to the nominal time to minimize the potential autonomic effects of blood 
draws on these measurements and remaining assessments (eg, clinical laboratory tests sampling, physical examination, and height and body weight 
measurements) may be performed after the nominal time point. 
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TABLE OF CONTENTS 
1 
SYNOPSIS .................................................................................................................. 2 
1.1 
Schedule of Assessments and Procedures ............................................................ 12 
TABLE OF CONTENTS .......................................................................................................... 16 
LIST OF TABLES .................................................................................................................... 18 
LIST OF FIGURES .................................................................................................................. 18 
LIST OF ABBREVIATIONS ................................................................................................... 19 
STUDY ADMINISTRATIVE STRUCTURE ......................................................................... 21 
2 
INTRODUCTION AND BACKGROUND ............................................................. 22 
2.1 
Introduction ......................................................................................................... 22 
2.2 
Study Vaccine Background ................................................................................. 22 
2.2.1 
Receptor Binding Domain Vaccine Strategy ....................................................... 22 
2.2.2 
TAP-COVID-19 Vaccine – A Novel Vaccine for COVID-19 Disease 
Prevention ........................................................................................................... 22 
2.2.3 
CpG Adjuvant ..................................................................................................... 23 
2.2.4 
Data Supporting Development of TAP-COVID-19 Vaccine ............................... 23 
2.3 
Summary of Findings to Date .............................................................................. 24 
2.4 
Study Rationale ................................................................................................... 25 
2.5 
Dose Rationale .................................................................................................... 25 
3 
OBJECTIVES AND ENDPOINTS ......................................................................... 26 
3.1 
Objectives ............................................................................................................ 26 
3.1.1 
Primary Objective ................................................................................................ 26 
3.1.2 
Secondary Objectives .......................................................................................... 26 
3.1.3 
Exploratory Objectives ........................................................................................ 26 
3.2 
Endpoints ............................................................................................................. 26 
3.2.1 
Primary Endpoints ............................................................................................... 26 
3.2.2 
Secondary Endpoints ........................................................................................... 27 
3.2.3 
Exploratory Endpoints ......................................................................................... 27 
4 
STUDY DESIGN ...................................................................................................... 28 
4.1 
Study Design and Overview ................................................................................ 28 
4.1.1 
Duration of Study ................................................................................................ 32 
4.1.2 
Interim Safety Data Review ................................................................................. 32 
4.1.3 
Definition of Study Completion .......................................................................... 33 
4.1.4 
End of Study ........................................................................................................ 33 
5 
SELECTION AND WITHDRAWAL OF SUBJECTS .......................................... 34 
5.1 
Inclusion Criteria ................................................................................................. 34 
5.2 
Exclusion Criteria ................................................................................................ 35 
5.3 
Screen Failures .................................................................................................... 38 
5.4 
Decision to Administer Second Vaccination ....................................................... 38 
5.5 
Individual Discontinuation Criteria ..................................................................... 39 
5.6 
Subject Withdrawal ............................................................................................. 39 
5.7 
Independent Safety Review Committee, Study Stopping Rules, and Study 
Termination ......................................................................................................... 40 
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5.7.1 
Independent Safety Review Committee ............................................................... 40 
5.7.2 
Study Halting Rules ............................................................................................. 41 
5.7.3 
Study Termination ............................................................................................... 42 
6 
TREATMENT OF SUBJECTS ............................................................................... 44 
6.1 
Identity of Study Vaccines................................................................................... 44 
6.2 
Treatments Administered .................................................................................... 44 
6.3 
Method of Assigning Subjects to Treatment Groups ........................................... 45 
6.4 
Measurements of Treatment Compliance ............................................................ 45 
6.5 
Study Vaccine Storage, Accountability, and Retention ....................................... 45 
6.5.1 
Storage Conditions .............................................................................................. 45 
6.5.2 
Drug Accountability and Retention ..................................................................... 45 
6.6 
Packaging and Labeling ....................................................................................... 45 
6.6.1 
Study Vaccine ..................................................................................................... 45 
6.6.2 
Blinding of Treatment Assignment ...................................................................... 46 
6.6.3 
Unblinding of Treatment Assignment.................................................................. 46 
6.7 
Concomitant Medications and Procedures and Other Restrictions....................... 47 
6.7.1 
Concomitant Medications and Procedures ........................................................... 47 
6.7.2 
Other Restrictions ................................................................................................ 47 
7 
STUDY ASSESSMENTS AND PROCEDURES .................................................... 48 
7.1 
Pandemic Safety Procedures ................................................................................ 48 
7.2 
Medical and Surgical History .............................................................................. 48 
7.3 
Demographic Characteristics ............................................................................... 48 
7.4 
Physical Measurements ....................................................................................... 48 
7.5 
Immunogenicity ................................................................................................... 48 
7.6 
SARS-CoV-2 Exposure and Asymptomatic Monitoring ..................................... 49 
7.7 
Safety Assessments ............................................................................................. 49 
7.7.1 
Adverse Events .................................................................................................... 49 
7.7.2 
Reactogenicity Assessments ................................................................................ 50 
7.7.3 
Laboratory Tests .................................................................................................. 50 
7.7.4 
Vital Signs ........................................................................................................... 51 
7.7.5 
Physical Examination .......................................................................................... 52 
7.7.6 
Appropriateness of Safety Assessments .............................................................. 52 
8 
ADVERSE EVENTS ................................................................................................ 53 
8.1 
Recording Adverse Events .................................................................................. 53 
8.2 
Assessment of Adverse Events ............................................................................ 54 
8.2.1 
Serious Adverse Events, Medically Attended Adverse Events, New Onset 
Chronic Medical Conditions, Adverse Events of Special Interest, and Potential 
Immune-mediated Conditions.............................................................................. 54 
8.2.2 
Adverse Events of Special Interest ...................................................................... 54 
8.2.3 
Intensity ............................................................................................................... 55 
8.2.4 
Relationship to Study Vaccine ............................................................................. 55 
8.3 
Discontinuation Due to Adverse Events .............................................................. 56 
8.4 
Reporting Serious Adverse Events and Adverse Events of Special Interest ........ 56 
8.5 
Pregnancy ............................................................................................................ 56 
8.6 
Drug-induced Liver Injury ................................................................................... 57 
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9 
STATISTICAL CONSIDERATIONS .................................................................... 58 
9.1 
Sample Size Calculation ...................................................................................... 58 
9.2 
Analysis Populations ........................................................................................... 58 
9.3 
Randomization .................................................................................................... 59 
9.4 
Endpoints ............................................................................................................. 60 
9.5 
Interim Analyses .................................................................................................. 60 
9.6 
Immunogenicity Analysis .................................................................................... 60 
9.7 
Cellular Analysis ................................................................................................. 61 
9.8 
Safety Analysis .................................................................................................... 61 
10 
ACCESS TO SOURCE DATA/DOCUMENTS ..................................................... 62 
11 
QUALITY CONTROL AND QUALITY ASSURANCE ....................................... 63 
11.1 
Conduct of Study ................................................................................................. 63 
11.1.1 
Protocol Deviations ............................................................................................. 63 
11.2 
Protocol Amendments ......................................................................................... 63 
11.3 
Monitoring of Study ............................................................................................ 63 
12 
ETHICS ..................................................................................................................... 65 
12.1 
Institutional Review Board Approval .................................................................. 65 
12.1.1 
Ethics Review Prior to Study ............................................................................... 65 
12.1.2 
Ethics Review of Other Documents ..................................................................... 65 
12.2 
Written Informed Consent ................................................................................... 65 
13 
DATA HANDLING AND RECORD KEEPING ................................................... 66 
13.1 
Data Reporting and Case Report Forms .............................................................. 66 
13.1.1 
Case Report Forms .............................................................................................. 66 
13.1.2 
Laboratory Data ................................................................................................... 66 
13.1.3 
Retention of Source Documents .......................................................................... 66 
13.2 
Retention of Essential Documents ....................................................................... 66 
14 
ADMINISTRATIVE INFORMATION .................................................................. 67 
14.1 
Financing and Insurance ...................................................................................... 67 
14.2 
Publication Policy ................................................................................................ 67 
15 
REFERENCES ......................................................................................................... 68 
16 
SIGNATURES .......................................................................................................... 70 
APPENDIX A 
DIARY CARD EXAMPLE ......................................................................... 72 
APPENDIX B 
POTENTIAL IMMUNE-MEDIATED MEDICAL CONDITIONS ......... 74 
APPENDIX C 
ADDITIONAL ELISA DETAILS ............................................................... 77 
 
List of Tables 
Table 1-1 
Schedule of Assessments and Procedures ............................................................ 12 
Table 6-1 
Study Vaccines .................................................................................................... 44 
Table 7-1 
Clinical Safety Laboratory and Screening Tests .................................................. 51 
Table 8-1 
DAIDS Adverse Events Intensity Assessment ..................................................... 55 
 
List of Figures 
Figure 4-1 
Study Schematic for Parts A and B ...................................................................... 29 
  
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LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
ACE-2 
angiotensin converting enzyme 2 
ADE 
antibody-mediated disease enhancement 
AE 
adverse event 
AESI 
adverse event of special interest 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
API 
active pharmaceutical ingredient 
AST 
aspartate aminotransferase 
BMI 
body mass index 
CBER 
Center for Biologics Evaluation and Research 
CDC 
Centers for Disease Control and Prevention 
CD4+ 
white blood cell T helper cell subtype 
CD8+ 
white blood cell T cytotoxic cell subtype 
CFR 
Code of Federal Regulations 
cGMP 
current Good Manufacturing Practice 
CI 
confidence interval 
CoV 
coronavirus 
CpG 
Cytosine PhosphoGuanine 
CPMP 
Committee for Proprietary Medicinal Products 
CRA 
clinical research associate 
CRU 
clinical research unit 
CRO 
contract research organization 
CSR 
clinical study report 
CV% 
coefficient of variation (percentage) 
DAIDS 
Division of AIDS 
DILI 
drug-induced liver injury 
DNA 
deoxyribonucleic acid 
ECG 
electrocardiogram 
ECMO 
extracorporeal membrane oxygenation 
eCRF 
electronic case report form 
ELISA 
enzyme-linked immunosorbent assay 
EOS 
end-of-study 
FcRII 
Fc gamma region II of IgG 
FDA 
Food and Drug Administration 
FIH 
first-in-human 
FiO2 
fraction of inspired oxygen 
FSH 
follicle-stimulating hormone 
GeoCV% 
geometric coefficient of variation (percentage) 
GGT 
gamma-glutamyl transferase 
GMFR 
geometric mean fold rise 
GMI 
geometric mean increase 
GMT 
geometric mean titer 
H1N1 
influenza A virus subtype H1N1 
H3N2 
influenza A virus subtype H3N2 

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Abbreviation 
Definition 
HBsAg 
hepatitis B surface antigen 
HCV 
hepatitis C virus 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HIV 
human immunodeficiency virus 
ICD 
International Classification of Diseases 
ICF 
informed consent form 
ICU 
intensive care unit 
Ig 
immunoglobulin 
IL 
interleukin 
IM 
intramuscular 
IRB 
institutional review board 
IFN- 
interferon gamma 
iSRC 
independent safety review committee 
KBP 
Kentucky BioProcessing, Inc. 
MAAE 
medically attended adverse event 
MedDRA 
Medical Dictionary for Regulatory Activities 
MERS-CoV 
Middle East Respiratory Syndrome coronavirus 
mITT 
Modified Intent-to-Treat Population 
NOCD 
new onset chronic disease 
PaO2 
partial pressure of oxygen 
PBMC 
peripheral blood mononuclear cell 
PE 
physical examination 
PP 
Per Protocol  
RBD 
receptor binding domain 
RBD-Fc 
fusion protein containing RBD fused to the Fc domain of a human IgG1 
RT-PCR 
reverse transcription polymerase chain reaction 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
SOP 
standard operating procedure 
SpO2 
oxygen saturation 
SRM 
study reference manual 
SSP 
study-specific procedure 
TAP 
Tobacco Mosaic Virus Antigen Presentation 
TAP-COVID-19 Tobacco Mosaic Virus Antigen Presentation SARS-CoV-2 virus Receptor Binding Domain 
fused to Fc Domain 
TEAE 
treatment-emergent adverse event 
TLR9 
Toll-like Receptor 9 
TMV 
Tobacco Mosaic Virus 
ULN 
upper limit of normal 
US or USA 
United States of America 
VS 
vital signs 
WHO 
World Health Organization 
WOCBP 
Women of childbearing potential 

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STUDY ADMINISTRATIVE STRUCTURE 
Sponsor: 
Kentucky BioProcessing, Inc.  
3700 Airpark Drive 
Owensboro, KY 42301 USA 
Telephone: 270-689-257 
Sponsor’s Contact: 
Oscar (Tony) A. Guzman, MD, CP 
Clinical Project Lead 
Kentucky BioProcessing, Inc. 
ICON Medical Monitor: 
Bart Chapman, MD 
ICON Clinical Research, LLC 
820 West Diamond Avenue, Suite 100 
Gaithersburg, MD 20878 USA 
ELISA (IgM & IgG) Antibody Titer and 
Cell Mediated Immunity Laboratories: 
VisMederi srl 
Strada del Petriccio e Belriguardo, 35, 
53100 Siena, Italia  
ICON Central Laboratory 
123 Smith Street 
Farmingdale, NY 11735 USA 
Neutralizing Antibody Laboratory: 
VisMederi srl 
Strada del Petriccio e Belriguardo, 35, 
53100 Siena, Italia 
Clinical Research Organization:  
ICON Clinical Research, LLC 
820 West Diamond Avenue, Suite 100 
Gaithersburg, MD 20878 USA 
Telephone: 301-944-6800 
Multiple clinical sites may be utilized for Parts A and B. Multiple sites are also planned for 
Part C. 
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President
Deleted: Laboratory

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2 
INTRODUCTION AND BACKGROUND 
2.1 
Introduction 
To date, seven CoVs capable of human infection have been identified, including SARS-CoV, 
MERS-CoV, and a newly identified CoV (SARS-CoV-2). These 3 viruses, when in the human 
population, are significant public health risks showing high fatality rates: SARS-CoV = 10%, 
MERS-CoV = 34.4% and SARS-CoV-2 = 6.1%. The SARS-CoV-2 virus has spread to 
>180 countries since December 2019, infected >5.7 million humans, and been attributed to 
>350,000 deaths worldwide [John Hopkins 2020]. These numbers are growing exponentially, 
creating worldwide health and economic crises. The emergence of this disease and its effects on 
human health and economic security demands urgent response. 
TAP-COVID-19 Vaccine is being developed for the prevention of SARS-CoV-2 infection in 
healthy adults aged 18 and older. For this Phase 1 Study, the TAP-COVID-19 vaccine will be 
evaluated with a CpG adjuvant based on preclinical studies showing it provides a Th1 biased 
immune response against SARS-CoV-2. 
2.2 
Study Vaccine Background 
2.2.1 
Receptor Binding Domain Vaccine Strategy 
Focusing CoV vaccine efforts around the RBD (S1 domain) of the spike glycoprotein have 
produced encouraging outcomes. SARS-CoV RBD has been shown to bind the human receptor 
for ACE-2, contains multiple conformation-dependent epitopes that can elicit high-titer 
neutralizing antibodies [Wang 2020; Kam 2007; Jaume 2012; Quinlan 2020]. Most relevant to the 
KBP vaccine strategy, in vivo studies showed that a fusion protein containing RBD-Fc elicited 
high levels of neutralizing antibodies against SARS-CoV in both immunized rabbits and mice. 
These antibodies blocked spike interaction with the human receptor ACE-2. Most interestingly, 
the RBD-Fc protein induced long lasting, potent neutralizing antibody titers maintained for 
12 months after immunization – even protecting most vaccinated mice from SARS-CoV challenge 
[Du 2007; Du 2009]. Importantly, many different versions of SARS or MERS-RBD vaccines have 
been developed and tested, alone and with adjuvant, produced in mammalian cells, and insect cells 
and plants. All have shown protection from infection through virus neutralization without 
accompanying immunopathology associated with full-length or trimerized S protein vaccines 
[Wang 2020; Kam 2007; Jaume 2012; Quinlan 2020]. 
2.2.2 
TAP-COVID-19 Vaccine – A Novel Vaccine for COVID-19 Disease 
Prevention 
Based on the prior experience with Coronavirus family viruses described above, KBP has 
developed the RBD-Fc antigen linked to its novel TAP platform to accelerate development of an 
effective and scalable vaccination strategy. The KBP platform combines the well-established 
speed and robustness of its transient Nicotiana benthamiana gene expression system with the 
immune stimulation effects of antigen-association with the inactivated TMV virus structure. Using 
standardized gene expression and downstream processing strategies, while maintaining a warm 

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base of naïve plants, the TAP platform has the potential to rapidly deliver vaccines with significant 
production potential of millions of doses of vaccine API per month.  
Historical preclinical data illustrates the ability of TAP vaccines to provide balanced humoral and 
cellular responses in mammals allowing efficacious responses to be generated against a wide range 
of pathogens with different immune correlates of protection [McCormick 2006a; McCormick 
2006b; Banik 2015; Arnaboldi 2016; Mallajosyula 2016; Mallajosyula 2014].  
The TAP vaccine system offers key advantages of:  
 Speed: <10 weeks from sequence to cGMP vaccine  
 Balanced immune response: effective stimulation of both Th1 and Th2 arms of the immune 
system 
 Stability: showing room temperature shelf life past 6-months at room temperature with no 
loss of potency  
 Scalability: potential to deliver millions of doses of vaccine API per month 
 Robustness: showing safety in murine, ferret, and rabbit preclinical models and efficacy 
against challenge with seven viruses and three bacterial pathogens, including human 
influenza virus, Yersinia pestis, Francisella tularensis, and Mycobacterium tuberculosis 
2.2.3 
CpG Adjuvant 
The TAP-COVID-19 Vaccine will be combined with CpG 7909 adjuvant. CpG 7909 is a short 
(24 nucleotide) synthetic form of DNA that mimics bacterial and viral genetic material that, when 
included into a vaccine, increases the body’s immune response through engagement of TLR9 
within antigen presenting dendritic cells and B cells. TLR9-engaging adjuvants are known to 
generate Th1 cell- and cytokine-mediated immune responses (IFN- and IL-2) generated by Th1 
cells and IgG2a isotype antibodies and to vaccine antigens and pathogens. Generation of a 
Th1-biased humoral response may reduce risk associated with antibody-mediated disease 
enhancement based on FcRII receptor affinity for Th1 antibodies versus Th2 antibodies [de Alwis 
2020; Fierz 2020]. 
2.2.4 
Data Supporting Development of TAP-COVID-19 Vaccine 
2.2.4.1 
Binding to CR3022 Monoclonal Antibodies 
Preliminary data indicates the RBD-Fc intact antigen binds to the human ACE-2 receptor and a 
SARS-CoV-2 RBD-specific, human neutralizing monoclonal antibody, CR3022. The data shows 
strong, dose-dependent binding of CR3022 to RBD-Fc antigen and RBD-Fc TAP vaccine. The 
RBD-Fc candidate antigens show >5X reactivity to CR3022 compared with commercially sourced 
control SARS spike and RBD reagents. These data suggest that the purified SARS-CoV-2 RBD-Fc 
antigen maintains essential conformational epitopes in a manner superior to commercially 
purchased reagents. 

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2.2.4.2 
Binding to ACE-2 Receptor 
Recombinant ACE-2 complexes containing RBD-Fc can be immunoprecipitated by ACE-2 
specific antisera in vitro. However, this does not provide a quantitative measure of binding. 
Quantitative and functional ACE-2 binding was performed using confocal microscopy and 
analysis by co-localization and competitive binding methods on Vero e6 cells in collaboration with 
scientists at the University of Louisville, Center for Predictive Medicine and Department of 
Microbiology & Immunology. The ability of the native agonist, angiotensin II, was compared with 
the RBD-Fc fusion or concentration dependent ability to block binding of an ACE-2 specific 
antibody to the receptor on living cells. Influenza H7 hemagglutinin was used as a control. 
FAM-angiotensin II bound to Vero e6 cells, with an average of a 2.79-fold increase over the 
non-specific H7 control. 
Binding of the RBD-Fc antigen to Vero e6 cells occurred in a concentration-dependent manner 
with an increase of 2.58-fold increase over the H7 control. Binding of H7 did not impact detection 
of ACE-2 by monoclonal antibody at any concentration. 
SARS-CoV-2 RBD-Fc fusion antigen shows functional conformation and activity through the 
binding by CR3022 and ACE-2. Binding to ACE-2 shows similar affinity and specificity as 
angiotensin II suggesting that the conformation of the spike protein RBD in the antigen-antibody 
complex is comparable to that observed with native SARS-CoV-2 spike protein. The data suggests 
that both antigen-antibody complexes display the correct structure necessary to elicit neutralizing 
antibodies to the RBD of SARS-CoV-2 spike protein. 
2.3 
Summary of Findings to Date 
KBP is also actively developing a quadrivalent seasonal influenza vaccine, TAP-V001, using the 
TAP platform. Nonclinical studies performed to support TAP-V001 are relevant and supportive of 
the TAP-COVID-19 program based on the quantities of the vaccine components. In particular, 
IND-enabling pharmacokinetic/biodistribution and GLP repeat dose toxicology studies have been 
completed using two different formulations of TAP-V001 vaccine that demonstrated: 
 No observed treatment-related or toxicologically significant clinical findings or inoculation 
site reactogenicity  
 No observed treatment-related or toxicologically significant effects for body weights, body 
weight changes, food consumption, body temperatures, ophthalmology, clinical chemistry, 
hematology, organ weights, and gross and microscopic pathology 
 Dose dependent TMV-specific RT-PCR signal measured at site of injection with rapid 
clearance from all non-target organs 
 Maintenance of TMV-specific RT-PCR signal in immune-processing organs, including 
lymph nodes and spleen 
 Efficacy in two ferret challenge studies, revealing statistically improved H1N1 clearance 
and statistically equivalent H3N2 clearance compared with Fluzone® control. 
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The same platform manufacturing process for production of TAP-V001 is used in the production 
of TAP-COVID-19, with the exception of the affinity chromatography resin, and a similar drug 
product formulation is employed. 
2.4 
Study Rationale 
Multiple vaccines have been approved for emergency use for the prevention of SARS-CoV-2, with 
other vaccines close to being available either through emergency use or licensed vaccines. 
Although work continues on antiviral treatments for SARS-CoV-2, given the crisis of COVID-19 
infections in the world, the fast expansion to the US and other parts of the world, and the global 
push to vaccinate everyone, additional sources of effective vaccine will be needed. 
2.5 
Dose Rationale 
As SARS-CoV-2 is a newly emergent respiratory viral disease, naïve subjects are expected to 
require a two dose (prime-boost) immunization regimen to generate a suitable immune response 
to offer protection from infection. The TAP-COVID-19 vaccine dose levels to be evaluated have 
been established using a prime-boost dosing strategy in mice as a model species to characterize 
the vaccine’s immunogenicity. Two doses of TAP-COVID-19 have demonstrated a robust and 
dose-dependent increase in the humoral antibody response to the vaccine in both total antibody 
and neutralizing antibody titers. This response was seen in separate KBP studies conducted at two 
different academic centers.  
The selected regimen is anticipated to be safe based on nonclinical toxicology studies conducted 
in rabbits which employed a 4-fold higher antigenic dose levels of a quadrivalent influenza vaccine 
candidate. There were no toxicologically relevant findings and it was determined that a property 
of TAP-based vaccines is the trafficking to immune organs (draining lymph nodes and spleen) 
which may serve as a mechanism for driving the immune response.  
Lastly, the proposed rationale for dose level and the dosing regimen is based on historical 
experience with other pandemic respiratory viral diseases including influenza and prior 
coronavirus outbreaks and is also consistent with other ongoing SARS-CoV-2 clinical studies. 

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3 
OBJECTIVES AND ENDPOINTS 
3.1 
Objectives 
3.1.1 
Primary Objective 
To assess the safety and reactogenicity of two doses of TAP-COVID-19 vaccine with CpG 
adjuvant for 7 days post vaccination compared with placebo as determined by solicited local and 
systemic reactogenicity 
3.1.2 
Secondary Objectives 
To compare the frequency of unsolicited AEs of each dose of TAP-COVID-19 vaccine with CpG 
adjuvant through Day 43 and SAEs, MAAEs, NOCDs, and AESIs through Day 365  
Comparisons include: 
 High dose (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG) to placebo 
 Low dose (15 μg TAP-COVID-19 vaccine + 0.5 mg CpG) to placebo 
 High dose (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG) to low dose 
(15 μg TAP-COVID-19 vaccine + 0.5 mg CpG) 
To evaluate the immunogenicity of TAP-COVID-19 vaccine with CpG adjuvant compared with 
placebo in terms of antibody assessed by GMTs of both spike RBD IgG and IgM antibodies and 
neutralizing antibody response, GMFR in neutralizing titer from baseline in all treatment groups 
at Days 8, 22, 29, 43, 90, 181, 273, and 365 relative to baseline 
3.1.3 
Exploratory Objectives 
To assess cellular immunity by measuring the numbers of cytokine producing CD4+ and CD8+ 
T-cells from PBMCs response to vaccine in all treatment groups at Days 8, 22, 29, 43, 90, 181, 
273, and 365 compared to baseline  
To assess the immunogenicity of the RBD and Fc component of the vaccine 
3.2 
Endpoints 
3.2.1 
Primary Endpoints 
Occurrence of Solicited AEs: 
 Solicited administration site reactions (eg, pain, tenderness, erythema/redness, 
induration/swelling) during the 7-day follow-up period after each vaccination (Day 1-8 and 
Day 22-29) 
 Solicited systemic events (eg, fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia) 
during the 7-day follow-up period after each vaccination (Day 1-8 and Day 22-29) 

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3.2.2 
Secondary Endpoints 
Safety: 
 Unsolicited AEs, MAAEs, and AESIs up to Day 43  
 SAEs, MAAEs, NOCDs, and AESIs up to Day 365 (approximately 1 year after first 
vaccination) 
Immunogenicity: 
 Vaccine ELISA of both RBD IgG and IgM antibodies and neutralizing antibody titers for 
each treatment group: 
o GMT at baseline and Days 15, 22, 43, 90, 181, 273, and 365 
o GMT ratio (GMTplacebo/GMTTAP-COVID-19) at baseline and Days 22, 29, 43, 90, 181, 
273, and 365 
o GMFR at Days 8, 22, 29, 43, 90, 181, 273, and 365 relative to baseline 
o Seroconversion rates on Days 8, 15, 22, 29, 43, 90, 181, 273, and 365. Seroconversion 
is defined as the proportion of subjects at the respective time point that have 
detectable antibodies (IgG and IgM) against SARS-CoV-2 Spike Protein RBD 
following challenge with vaccine (and potentially by natural asymptomatic or 
symptomatic infection by the virus in case of a placebo subject). 
o GMI on Days 8, 22, 29, 43, 90, 181, 273, and 365 
3.2.3 
Exploratory Endpoints 
Cellular immunity: 
 The number of cytokine producing CD4+ and CD8+ T-cells from PBMCs responsive to 
vaccine antigens in all treatment groups on Days 8, 22, 29, 43, 90, 181, 273, and 365 
compared to baseline  
Immunogenicity: 
⁃ 
Anti-RBD and anti-Fc antibodies at baseline and Days 8, 15, 22, 29, 43, 90, 181, 273, and 
365 
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4 
STUDY DESIGN 
4.1 
Study Design and Overview 
This is an FIH, observer-blinded, randomized, placebo-controlled, parallel group study to evaluate 
the safety and immunogenicity of TAP-COVID-19 vaccine with CpG adjuvant in healthy adult 
subjects in 2 age groups, Part A (18-49 years) and Part B (50-85 years). A study schematic is 
presented in Figure 4-1. 
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Figure 4-1 
Study Schematic for Parts A and B  
  
 
Abbreviations: High Dose = 45 μg TAP-COVID-19 vaccine + CpG (0.5 mg); iSRC = independent Safety Review Committee;  
Low Dose = 15 μg TAP-COVID-19 vaccine+ CpG (0.5 mg); Mtg = meeting 

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Part A and Part B: 
Subjects will be screened up to 14 days (Day -14 to Day -1) before randomization. Overall, 
approximately 90 eligible healthy adults ages 18-49 years (inclusive) will be enrolled for Part A 
and 90 eligible healthy adults ages 50-85 years will be enrolled for Part B.  
Sentinel dosing will be utilized in this FIH study. Sentinel cohorts will be used for the following 
groups:  
 Part A (18-49 years) low dose (15 μg TAP-COVID-19 vaccine + 0.5 mg CpG)  
 Part B (50-85 years) low dose (15 μg TAP-COVID-19 vaccine + 0.5 mg CpG)  
 Part A (18-49 years) high dose (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG)  
 Part B (50-85 years) high dose (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG)  
Three sentinel subjects from each part will be randomized 2:1 (active:placebo). The iSRC will 
review the safety data for the sentinel subjects through Day 8 prior to enrollment of the remaining 
cohort subjects randomized 2:1 (active:placebo). In the event that iSRC has not met for the post 
Day 8 review because the entire sentinel group (n = 3) has not completed Day 8 before a sentinel 
subject is to receive the second vaccine on Day 22, the iSRC will meet on an ad hoc basis, to 
ensure there are no safety concerns and that none of the Individual Discontinuation Criteria 
(Section 5.5) or Study Halting Rules (Section 5.7.2) have been met, prior to the sentinel subjects 
receiving the second vaccine. 
When all subjects in Part A (18-49 years) low dose have received the first vaccination and have 
all safety data through Day 8, the iSRC (Section 5.7.1) will convene and review the safety data to 
ensure that there are no safety concerns and that none of the Study Halting Rules have been met 
(Section 5.7.2) before recommending that the study enroll Part A high dose and Part B 
(50-85 years) low dose.  
When all subjects in Part B (50-85 years) low dose have received the first vaccination and have all 
safety data through Day 8, the iSRC will convene and review the safety data to ensure that there 
are no safety concerns and that none of the Study Halting Rules have been met before 
recommending that the study enroll Part B high dose. 
The iSRC will convene and review the safety data when a minimum of 23 subjects have completed 
Day 29 after the second vaccination for Part A (low and high dose) and for Part B (low and high 
dose) to ensure that there are no concerns. 
Both Part A (18-49 years) and Part B (50-85 years) will be randomized in a 2:1 ratio 
(active:placebo) for each treatment dose (15 μg and 45 μg TAP-COVID-19 vaccine + 0.5 mg CpG) 
for a total of 90 subjects per Part (30 subjects 15 μg TAP-COVID-19 vaccine + 0.5 mg 
CpG:30 subjects 45 μg TAP-COVID-19 vaccine + 0.5 mg CpG:30 subjects placebo). 
Treatment A: TAP-COVID-19 vaccine (15 μg) + CpG (0.5 mg) IM injection on 
Day 1 and Day 22 (±3 days) 

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Treatment B: TAP-COVID-19 vaccine (45 μg) + CpG (0.5 mg) IM injection on 
Day 1 and Day 22 (±3 days) 
Treatment C: Placebo (buffered saline solution) IM injection on Day 1 and Day 22 
(±3 days) 
Study vaccine will be prepared by an unblinded site pharmacist and administered at the clinical 
research site on Day 1 and Day 22 (±3 days) by unblinded CRU personnel. Subjects will be 
observed for immediate AEs and/or reactogenicity for approximately 60 minutes after 
administration of vaccine. Subjects will be provided with a Diary Card and will be trained to record 
specifically elicited systemic and local symptoms daily as well as any additional AEs during the 
7-day follow-up period after each vaccination. Visits will be conducted at the clinical site on an 
outpatient basis or as a telephone visit per the Schedule of Assessments and Procedures 
(Table 1-1). Subjects will participate in the study for approximately 1 year from the first dose. 
AEs and concomitant medications will be captured through Day 43. Blood and serum samples for 
safety laboratory tests, RBD IgG and IgM antibodies, and neutralizing antibody titers, cell-
mediated immunity, and other future biomedical research will be obtained at baseline and before 
administration of vaccine dose 2 and after each vaccination per the Schedule of Assessments and 
Procedures (Table 1-1). SAEs, MAAEs, NOCDs, and AESIs only will be captured after Day 43 to 
study completion (Day 365 [approximately 1 year after vaccination]). 
Prior to receiving a second dose of vaccine, subjects will have the following assessments 
performed to ensure eligibility: vital signs (including temperature), review of clinical laboratory 
test results to date, nasopharyngeal swab Day 15 to check for SARS-CoV-2 infection (RT-PCR 
result must be received by the CRU and negative prior to the second vaccine administration), 
medical history since last visit including AE assessment for SAEs, Grade 3 AEs, or AESIs that are 
possibly, probably, or definitely related to study vaccine without a plausible alternative 
explanation, targeted physical examination, recheck of eligibility criteria, and pregnancy test (as 
applicable). 
Subjects will be monitored for SARS-CoV-2 exposure for potential asymptomatic infection 
throughout the study.  
 If a subject has a positive or borderline ELISA anti-N IgG result, sites should have the 
subject return for an unscheduled PCR. If the ELISA is positive and the PCR is negative, 
the sites should follow the subjects using the standard of care under Investigator discretion, 
retesting ELISA at the next study visit(s) or sooner (per the Investigator’s decision). 
 If the subject has a positive or borderline ELISA anti-N IgG AND a positive PCR test, the 
clinical sites should bring the subjects back for repeat PCR testing as described below. 
 The clinical sites should continue to collect PCR tests if a subject is experiencing possible 
COVID-19 symptoms, or had possible exposure to SARS-CoV-2 (ie, close contact tests 
positive for SARS-CoV-2). Testing will occur every 2 weeks for a total of 4 weeks (if 
2 consecutive negative tests) or until negative (x2) after a positive result. Positive results 
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will be reported as an AESI (Section 8.2.2) and subjects followed for disease severity, 
duration, and outcome. 
Subjects who are seropositive for SARS-CoV-2 and asymptomatic will be allowed to enroll into 
Parts A and B of the study as long as the subject is RT-PCR negative. 
Additional details for the ELISA test results are presented in Appendix C. 
Part C Expansion (Optional): 
The Part C Expansion may be conducted to confirm the safety and immunogenicity of a selected 
dose across the broad target age span using a larger sample size. The proposed sample size was 
selected based on WHO guidelines on clinical evaluation of vaccines: regulatory expectations 
Annex I (2001), which states that approximately 300 subjects are needed to identify common local 
reactogenicity events. A larger sample size will assist in a better characterization of kinetics and 
range of immunity (neutralizing antibody titers) and provide a more reliable output of 
seropositivity and seroconversion to TAP-COVID-19 immunization. With the limited clinical 
experience with SARS-CoV-2 vaccines and the current lack of a biomarker correlate of protection, 
the generation of this larger data set is relevant to inform the design and implementation of a Phase 
3 program. After review of safety and immunogenicity data from Parts A and B through Day 43, 
a dose for the Phase II expansion study will be recommended by the iSRC. Progression to Part C 
will only take place after CBER has had the opportunity to review the human clinical plus 
additional nonclinical data and concurs with the plan to proceed with enrollment. Subjects 
≥18 years of age will be enrolled and randomized 1:1 (selected active dose:placebo). Up to 
1000 subjects will be enrolled at the chosen dose to provide expanded dose confirmation, safety, 
and immunogenicity data. Although all subjects in Part C will have safety laboratory tests 
performed at screening, only the first 200 subjects in Part C will have safety laboratory tests 
performed at all post-dose time points. The remaining subjects in Part C will not have safety 
laboratory tests performed at any of the post-dose time points unless the Investigator deems it 
necessary. 
Subjects who are seropositive for SARS-CoV-2 and asymptomatic will be allowed to enroll into 
Part C of the study. 
4.1.1 
Duration of Study 
Each subject will receive two doses of study vaccine or placebo, the first on Day 1 and the second 
on Day 22 (±3 days). The total duration of subject participation is approximately 1 year (including 
screening, treatment, and follow-up periods).  
4.1.2 
Interim Safety Data Review 
For all of the sentinel groups, the iSRC will meet to review the sentinel subjects’ safety and 
tolerability data through Day 8. In the event that iSRC has not met for the post Day 8 review 
because the entire sentinel group (n = 3) has not completed Day 8 before a sentinel subject is to 
receive the second vaccine on Day 22, the iSRC will meet on an ad hoc basis, to ensure there are 
no safety concerns and that none of the Individual Discontinuation Criteria (Section 5.5) or Study 

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Halting Rules (Section 5.7.2) have been met, prior to the sentinel subjects receiving the second 
vaccine. 
When all subjects in Part A (18-49 years) low dose have received the first vaccination and have 
all safety data through Day 8, the iSRC (Section 5.7.1) will convene and review the safety data to 
ensure that there are no safety concerns and that none of the Study Halting Rules have been met 
(Section 5.7.2) before recommending that the study enroll Part A high dose and Part B low dose. 
The same strategy will be used for Part B when going from low to high dose.  
The iSRC will be asked to review unblinded immunogenicity and safety data when the first 
30 subjects vaccinated in the Part A low dose group (including active and placebo subjects) have 
data available from Day 1 through Day 43 for an assessment of the risk-benefit of the trial. For the 
interim analysis, treatment codes will be unblinded and only after the data are deemed ready for 
the analysis and the data has been monitored. The unblinded review will be completed by the iSRC 
only and the other team members (CRO [except for the unblinded team members preparing the 
data for unblinded iSRC review], Investigator, and site personnel) will remain blinded until 
completion of the study. The Sponsor will be unblinded at the interim analysis. 
The iSRC will also meet when a minimum of 23 subjects have completed Day 29 after the second 
vaccination for Part A (low and high dose) and for Part B (low and high dose) to review safety 
data to ensure that there are no concerns. 
The iSRC will also review all data through Day 43 for Part A and for Part B in both dose groups 
to monitor for ongoing safety concerns and immunogenicity analysis. When the Parts A and B 
Day 43 (low and high dose) review is complete, the iSRC will recommend a dose for the Part C 
Expansion (optional). Progression to Part C will only take place after CBER has had the 
opportunity to review the Day 43 data from Parts A and B and concurs with the plan to proceed 
with enrollment. 
4.1.3 
Definition of Study Completion 
End-of-study procedures will be performed as specified in the Schedule of Assessments and 
Procedures (Table 1-1); subjects who withdraw from the study early will have EOS procedures 
performed at the time of discontinuation. If a subject refuses to return for the EOS blood samples, 
the safety follow-up will be completed via telephone. Subjects with ongoing clinically significant 
clinical or laboratory findings will be followed until the finding is resolved or medically stable; 
reasonable attempts will be made to follow-up with subjects. The subject’s participation in the 
study will end once all study assessments and follow-up have been completed. 
4.1.4 
End of Study 
The end of the study is defined as the date when the last subject has completed all study procedures 
up to and including the EOS/early termination visit as specified in the Schedule of Assessments 
and Procedures (Table 1-1). 
Deleted: The remaining study cohorts will have an unblinded 
immunogenicity and safety data review when all subjects in the 
cohort have data available from Day 1 through Day 43. 
Deleted: only 
Deleted:  by treatment group (not by individual subjects)
Deleted: Sponsor, 
Deleted:  
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5 
SELECTION AND WITHDRAWAL OF SUBJECTS 
5.1 
Inclusion Criteria 
Subjects must meet all inclusion criteria to be eligible for study participation. In addition, racial 
and ethnic minorities will be sought to obtain a diverse study population. 
All Subjects 
1. Subject read, understood, and signed the ICF.  
2. Healthy adult males and females 18-49 years of age (Part A) or 50-85 years of age (Part B), 
inclusive, at screening. 
3. RT-PCR negative at time of screening.  
4. BMI of ≥ 18 and ≤ 30 kg/m2 (National Heart, Lung, and Blood Institute) at screening. 
BMI = weight (kg)/(height [m])2. 
5. Must be in general good health before study participation with no clinically relevant 
abnormalities that could interfere with study assessments. 
6. WOCBP and men whose sexual partners are WOCBP must be able and willing to use at least 
1 highly effective method of contraception (ie, include hysterectomy, bilateral salpingectomy, 
and bilateral oophorectomy, hormonal oral [in combination with male condoms with 
spermicide], transdermal, implant, or injection, barrier [ie, condom, diaphragm with 
spermicide]; intrauterine device; vasectomized partner [6 months minimum], clinically sterile 
partner; or abstinence) during the study.  
 
A female subject is considered to be a WOCBP after menarche and until she is in a 
postmenopausal state for 12 consecutive months (without an alternative medical cause) or 
otherwise permanently sterile.  
 
Note: Subjects not of childbearing potential are not required to use any other forms of 
contraception during the study. Non-childbearing potential is defined as subject 
confirmed:  
o Surgical sterilization (eg, bilateral oophorectomy, bilateral salpingectomy, bilateral 
occlusion by cautery [Essure System is not acceptable], hysterectomy, or tubal ligation)  
o Postmenopausal (defined as permanent cessation of menstruation for at least 
12 consecutive months prior to screening) with FSH ≥ 30 mIU/mL at screening 
7. WOCBP must have a negative urine pregnancy test before each vaccination. 
8. Must be able to attend all visits, including unscheduled visits if respiratory symptoms 
suggestive of SARS-CoV-2 infection develop during the study, for the duration of the study 
and comply with all study procedures, including daily completion of the Diary Card for 7 days 
after each injection. 

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5.2 
Exclusion Criteria 
Subjects will not be eligible for study participation if they meet any of the exclusion criteria, or 
will be discontinued at the discretion of the Investigator if they develop any of the exclusion criteria 
during the study. 
Parts A and B 
1. History of an acute or chronic medical condition including dementia that, in the opinion of the 
Investigator, would render vaccination unsafe or would interfere with the evaluation of 
responses. Chronic conditions that are NOT included on the CDC’s list of subjects at higher 
risk for severe illness from SARS-CoV-2 (CDC COVID-19 website) are acceptable if the 
condition has been stable for the 3 months prior to vaccine administration (Day 1), with no 
medication changes, and no hospitalization in the past 6 months. 
2. History of any medical conditions that place subjects at higher risk for severe illness due to 
SARS-CoV-2 including but not limited to cancer, chronic kidney disease at any stage, chronic 
lung disease, dementia or other neurological conditions, diabetes (Type 1 or Type 2), Down 
syndrome, heart conditions, HIV infection, immunocompromised state (weakened immune 
system), liver disease, overweight/obesity, pregnancy, sickle cell disease or thalassemia, 
smoker (current or former), transplants (solid organ or blood stem cell), stroke or 
cerebrovascular disease, and substance use disorders. (See the latest updates at the CDC 
COVID-19 website.) 
3. History of ongoing clinical condition or medication or treatments that may adversely affect the 
immune system. 
4. Individuals who are RT-PCR positive for SARS-CoV-2 at screening or prior to second dose 
of TAP-COVID-19 vaccine.  
5. Individuals who are at increased risk of exposure to SARS-CoV-2 (eg, healthcare workers, 
emergency responders).  
6. Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine 
administration.  
7. Living in a group care facility (eg, assisted living or nursing home). 
8. Individuals with any elevated (Grade 1 or higher) laboratory test assessed as clinically 
significant for age by the Investigator at screening (Guidance for Industry: Toxicity Grading 
Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical 
Trials (September 2007), Tables for Laboratory Abnormalities). 
9. Individuals with elevated (Grade 1 or higher) liver function enzyme at screening, may repeat 
testing once to re-assess clinical significance. If the retest comes back within normal range, the 
subject will be eligible for enrollment with Investigator and Medical Monitor approval. See 
below for the criteria for excluding subjects with elevated liver enzymes (once confirmed by 
retest): 
 
ALP, ALT, AST, or GGT >1.5 × ULN 
 
Total bilirubin >1.6 × ULN 

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10. Active neoplastic disease (excluding nonmelanoma skin cancer that was successfully treated) 
or a history of any hematological malignancy. “Active” is defined as having received treatment 
within the past 5 years. 
11. Long-term (greater than 2 weeks) use of oral or parenteral steroids, high-dose inhaled steroids 
(>800 μg/day of beclomethasone dipropionate or equivalent), or immunomodulatory drugs 
within 6 months before screening (nasal and topical steroids are allowed). 
12. History of autoimmune, inflammatory disease, or potential immune-mediated medical 
conditions (Appendix B). 
13. Women currently pregnant, lactating, or planning a pregnancy between enrollment and 
181 days after randomization. 
14. History of Guillain-Barré Syndrome.  
15. History of anaphylactic-type reaction to injected vaccines.  
16. Known or suspected hypersensitivity to 1 or more of the components of the vaccine, including 
thimerosal, tobacco, and CpG adjuvant.  
17. History of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of 
drug abuse or addiction within 12 months of screening. 
Note: In those regions where cannabis use is legal, it will be left to the discretion of the 
Investigator to decide if a subject is an occasional user or an abuser of cannabis. The 
Investigator should discuss user/abuser status on a case-by-case basis with the Medical 
Monitor prior to enrollment. 
18. Acute illness or fever within 3 days before study enrollment (enrollment may be delayed for 
full recovery if acceptable to the Investigator).  
19. Individuals currently participating or planning to participate in a study that involves an 
experimental agent (vaccine, drug, biologic, device, or medication); or who have received an 
experimental agent within 1 month (3 months for immunoglobulins) before enrollment in this 
study; or who expect to receive another experimental agent during participation in this study. 
20. Receipt of immunoglobulin or another blood product within the 3 months before enrollment in 
this study or those who expect to receive immunoglobulin or another blood product during this 
study.  
21. Individuals who intend to donate blood within 6 months after the first vaccination.  
22. Individuals using prescription medications for prophylaxis of SARS-CoV-2.  
23. Individuals who plan to receive another vaccine within the first 3 months of the study except 
influenza vaccine which should not be given within 2 weeks of study vaccine.  
24. Receipt of any other approved SARS-CoV-2 vaccine prior to the first study vaccine or within 
90 days after administration of the first study vaccine.  
25. Receipt of any other experimental coronavirus vaccine at any time prior to or during the study.  
26. Receipt of any investigational vaccine or drug within 1 month of enrollment and through the 
end of the study (1 year after first vaccination). 

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27. Plan to travel outside the subjects’ country of residence from enrollment through Day 43.  
28. History of surgery or major trauma within 12 weeks of screening, or surgery planned during 
the study. 
29. Significant blood loss (>450 mL) or has donated 1 or more units of blood or plasma within 
6 weeks prior to study participation. 
30. Strenuous activity (as assessed by the Investigator) within 48 hours prior to dosing (Days 1 
and 22). 
31. A positive urine drug screen without evidence of corresponding prescribed concomitant 
medication(s) at Screening. Note: A positive drug screen result with a corresponding 
prescribed concomitant medication will be allowed if, in the opinion of the investigator and 
Medical Monitor, the concomitant medication does not make the subject unsuitable to 
participate in the clinical trial. For a positive tetrahydrocannabinol result, refer to Exclusion 
Criteria #17. 
32. Positive alcohol screen. 
33. Positive screen for HIV-1 and HIV-2 antibodies, HBsAg, or HCV antibody. 
34. Involved in the planning or conduct of this study. 
35. Unwilling or unlikely to comply with the requirements of the study. 
36. Subject is an employee, contractor, friend of or relative of any employee of Sponsor, CRO, 
study site or site affiliate. 
Part C 
If the study proceeds to the Part C Expansion study to confirm the safety and immunogenicity of 
the selected dose of vaccine, the following exclusion criteria (Number, from Parts A and B above) 
will be not applicable. 
(5) Individuals who are at increased risk of exposure to SARS-CoV-2 (eg, healthcare workers, 
emergency responders). 
(6) Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine 
administration. 
 
(7) Living in a group care facility (eg, assisted living or nursing home). 
(31) A positive urine drug screen without evidence of corresponding prescribed concomitant 
medication(s) at Screening. Note: A positive drug screen result with a corresponding 
prescribed concomitant medication will be allowed if, in the opinion of the investigator and 
Medical Monitor, the concomitant medication does not make the subject unsuitable to 
participate in the clinical trial. 
(32) Positive alcohol screen. 
(33) Positive screen for HIV-1 and HIV-2 antibodies, HBsAg, or HCV antibody (Parts A and B). 
For Part C, subjects known to be HIV positive or have active Hepatitis B or C infection will 
be excluded. 

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5.3 
Screen Failures 
Subjects who are discontinued from the study prior to study vaccine administration will be 
considered screen failures and may be re-screened as long as the subject was not discontinued from 
the study due to noncompliance with the protocol (eg, positive urine drugs of abuse screen, etc.). 
If the subject is re-screened, the subject must be re-consented and have all of the screening 
procedures re-performed. 
Screen failure data will not be recorded in the eCRF. 
5.4 
Decision to Administer Second Vaccination 
Prior to administering the second vaccination, subjects will have the following 
procedures/assessments performed: 
 Inclusion/exclusion criteria recheck (including absence of acute illness or new medical 
condition) 
 Oral temperature 
 Targeted physical examination  
 Vital signs 
 Review of clinical safety laboratory test results to date 
 Urine pregnancy test, as applicable 
 Nasopharyngeal swab on Day 15 to check for SARS-CoV-2 infection (result must be 
received by the CRU and negative prior to the second vaccine administration). 
 Medical history since last visit including AE assessment for SAEs, Grade 3 AEs or AESIs 
that are possibly, probably, or definitely related to study vaccine without a plausible 
alternative explanation 
 Check of Study Halting Rules (Section 5.7.2) 
All assessments must be normal or be in agreement with inclusion/exclusion criteria in order for a 
subject to receive the second vaccination dose.  
For all of the sentinel groups, the iSRC will meet to review the sentinel subjects’ safety and 
tolerability data through Day 8. In the event that iSRC has not met for the post Day 8 review 
because the entire sentinel group (n = 3) has not completed Day 8 before a sentinel subject is to 
receive the second vaccine on Day 22, the iSRC will meet on an ad hoc basis, to ensure there are 
no safety concerns and that none of the Individual Discontinuation Criteria (Section 5.5) or Study 
Halting Rules (Section 5.7.2) have been met, prior to the sentinel subjects receiving the second 
vaccine. 

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5.5 
Individual Discontinuation Criteria 
The occurrence of the following findings in an individual subject may result in discontinuation 
from the study vaccine. Subjects will be asked to participate in the scheduled Follow-up Visits, 
including at a minimum Day 365, to check safety and immunogenicity. 
 Subjects experiences an SAE assessed as possibly related, probably related, or related to 
study vaccine without a plausible alternative explanation. 
 Subject has generalized urticaria during the 7-day post vaccination period. 
 Subject develops a Grade 4 local reaction for which there is no alternative plausible 
explanation.  
 Subject experiences laryngospasm, bronchospasm, or anaphylaxis after vaccine 
administration considered related to the vaccine.  
 Subject develops a fever >40°C/104°F during the 7 days post vaccination period that is 
assessed as possibly related, probably related, or related to study vaccine without a 
plausible alternative explanation. 
 Single Grade 3 AEs or AESIs that are possibly, probably, or definitely related to study 
vaccine without a plausible alternative explanation. 
 Subject experiences any Grade 3 or higher abnormality in the same laboratory parameter 
determined by the Investigator or medical monitor as clinically significant and that are 
assessed as possibly related, probably related, or related to study vaccine without a 
plausible alternative explanation.  
5.6 
Subject Withdrawal 
Subjects are free to withdraw from the study at any time, for any reason, and without prejudice to 
further treatment. The Investigator may withdraw a subject if, in the Investigator’s judgment, 
continued participation would pose unacceptable risk to the subject or to the integrity of the study 
data. All procedures for early withdrawal must be completed. Reasons for withdrawal may include: 
 AE 
 SAE that is possibly related, probably related, or related, without a plausible alternative 
explanation 
 Lost to follow-up 
 Physician decision 
 Pregnancy 
 Protocol deviation 
 Study terminated by Sponsor 
 Withdrawal by subject 
 Death 
 Other 

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Subjects who are withdrawn for reasons other than AEs may be replaced. 
In the event of a subject’s withdrawal from study vaccine, the Investigator will promptly notify 
the Sponsor and will make every effort to complete the EOS assessments, unless the subject 
withdraws consent. All withdrawn subjects with ongoing clinically significant clinical or 
laboratory findings will be followed until the finding is resolved or medically stable; reasonable 
attempts will be made to follow-up with subjects. The subject will also be asked to participate in 
a Follow-up Visit at approximately Day 365 to check safety and immunogenicity.  
Subjects may be withdrawn from receiving the second dose of the study vaccine if they meet 
specific Study Halting Rules (see Section 5.7.2) or Individual Discontinuation Criteria 
(Section 5.5). If a subject is withdrawn due to meeting a Study Halting Rule or Individual 
Discontinuation Criteria, they will be asked to participate in the scheduled Follow-up Visits, 
including at a minimum Day 365, to check safety and immunogenicity.  
5.7 
Independent Safety Review Committee, Study Stopping Rules, and Study 
Termination 
5.7.1 
Independent Safety Review Committee 
A safety review will be performed by the iSRC according to details established at the start of the 
study and provided in the iSRC charter. The Investigator will provide a brief summary to the iSRC 
of any pertinent safety events prior to the iSRC meeting. The three member iSRC will consist of, 
at a minimum, two physicians with experience in vaccines and one statistician.  
The iSRC will review the safety and tolerability data through Day 8 for each of the sentinel subject 
groups prior to the enrollment of the remaining cohort subjects. In the event that iSRC has not met 
for the post Day 8 review because the entire sentinel group (n = 3) has not completed Day 8 before 
a sentinel subject is to receive the second vaccine on Day 22, the iSRC will meet on an ad hoc 
basis, to ensure there are no safety concerns and that none of the Individual Discontinuation 
Criteria (Section 5.5) or Study Halting Rules (Section 5.7.2) have been met, prior to the sentinel 
subjects receiving the second vaccine. 
The iSRC will be convened to review all available safety data including solicited AEs, unsolicited 
AEs, SAEs, MAAEs, NOCDs, AESIs, vitals, safety laboratory, and physical exams results of 
Part A low dose when all subjects have received the first vaccination and have all safety data 
through Day 8. If there are no safety concerns after the iSRC meeting, study enrollment will 
continue to Part A high dose and Part B low dose. The same strategy will be used to move from 
Part B low dose to Part B high dose.  
The iSRC will also meet when a minimum of 23 subjects have completed Day 29 after the second 
vaccination for Part A (high and low dose) and for Part B (high and low dose) to review safety 
data to ensure that there are no concerns. 
The iSRC will be asked to review unblinded immunogenicity and safety data when the first 
30 subjects vaccinated in the Part A low dose group (including active and placebo subjects) have 
data available from Day 1 through Day 43 for an assessment of the risk-benefit of the trial. For the 
Deleted: The remaining study cohorts will have an unblinded 
immunogenicity and safety data review when all subjects in the 
cohort have data available from Day 1 through Day 43. 

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interim analysis, treatment codes will only be unblinded by treatment group (not by individual 
subjects) and only after the data are deemed ready for the analysis and the data has been monitored. 
The unblinded review will be completed by the iSRC only and the other team members (CRO 
[except for the unblinded team members preparing the data for unblinded iSRC review], 
Investigator, and site personnel) will remain blinded. The Sponsor will be unblinded at the interim 
analysis (Day 43). The iSRC/Sponsor will communicate immunogenicity data to the study team 
in a blinded manner so that clinical development decisions for additional studies can be made by 
the Sponsor.  
Cohort dose continuation/escalation will only occur if the iSRC determines that the current dose 
was safe and well tolerated. If justified by cumulative safety and tolerability data, the iSRC can 
dose escalate per protocol, select an intermediate dose (lower or higher), or repeat a dose. The 
decision to allow dose continuation/escalation into the next cohort will be documented and this 
decision, along with the safety information, will be communicated to the site. 
The iSRC will also meet on an ad hoc basis if any of the Study Halting Rules are met 
(Section 5.7.2). If a Study Halting Rule is met, the iSRC will proceed with an unblinded review of 
available safety data. After the meeting, the iSRC will make 1 or more of the following 
recommendations: 
 All vaccinations should resume 
 Specific treatment groups should be discontinued while other treatment groups should 
resume vaccinations 
 No vaccinations should resume  
 Modifications to study conduct (eg, additional safety or laboratory assessments) 
The blinded medical monitor will also assess cumulative safety information for this study per the 
Medical Monitoring Plan and advise the Sponsor of any of the safety findings (Section 5.7.2) have 
occurred.  
The iSRC will review unblinded safety data for any subject who dies, requires ICU admission due 
to SARS-CoV-2 infection, develops an AESI (Section 8.2.2) of autoimmune disease or potential 
immune-medicated medical condition (Appendix B), or experiences vaccine-associated enhanced 
respiratory disease. If the subject had received TAP-COVID-19, the iSRC may decide whether a 
study halt for vaccine-enhanced disease is required based on a review of all available clinical and 
preclinical safety and immunogenicity data. 
5.7.2 
Study Halting Rules 
The occurrence and confirmation of 1 or more of the following findings will result in suspension 
of further enrollment and study vaccine administration pending urgent review (within 1 week) of 
the safety data by the iSRC. Subjects who are withdrawn from study vaccine (if applicable) will 
continue to be monitored (Section 5.6) for safety and immunogenicity. 
1. One or more subjects experience an SAE assessed as possibly related, probably related, or 
related to study vaccine without a plausible alternative explanation. 
Deleted: Sponsor, 

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2. One or more subjects have generalized urticaria during the 7-day post vaccination period. 
3. One or more subjects develop a Grade 4 local reaction for which there is no alternative 
plausible explanation.  
4. One or more subjects experiences laryngospasm, bronchospasm, or anaphylaxis after 
vaccine administration considered related to the vaccine.  
5. One or more subjects develop a fever >40°C/104°F during the 7 days post vaccination 
period that is assessed as possibly related, probably related, or related to study vaccine 
without a plausible alternative explanation. 
6. Two or more subjects within an individual treatment group, or 2 or more subjects across 
treatment groups, experience any Grade 3 or higher abnormality in the same laboratory 
parameter determined by the Investigator or medical monitor as clinically significant and 
that are assessed as possibly related, probably related, or related to study vaccine without 
a plausible alternative explanation.  
Note: An unblinded statistician or designee will assist with determining whether stopping 
rule #6 is met. 
7. Two or more subjects across treatment groups experience a Grade 3 or higher AE, MAAE, 
or AESI of the same or similar preferred terms (as categorized by MedDRA) assessed as 
possibly related, probably related, or related to study vaccine without a plausible alternative 
explanation. 
8. Any subject with severe SARS-CoV-2 infection will be assessed for the possibility of 
vaccine-associated enhanced respiratory disease. Severe SARS-CoV-2 infection is defined 
as individuals who have virologically confirmed SARS-CoV-2 infection with any of the 
following: 
 Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30 breaths 
per minute, heart rate ≥ 125 bpm, SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 
< 300 mmHg) 
 Respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, 
mechanical ventilation or ECMO) 
 Evidence of shock (systolic blood pressure < 90 mmHg, diastolic blood pressure 
< 60 mmHg, or requiring vasopressors) 
 Significant acute renal, hepatic, or neurologic dysfunction 
 Admission to an ICU 
 Death due to SARS-CoV-2 infection 
5.7.3 
Study Termination 
The study may be terminated at any time by the Sponsor if serious side effects occur, if potential 
risks to study participants are identified, if the Investigator does not adhere to the protocol, or if, 
in the Sponsor’s judgment, there are no further benefits to be achieved from the study. In the event 

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that the clinical development of the study vaccine is discontinued, the Sponsor shall inform all 
Investigators/institutions and regulatory authorities. 

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6 
TREATMENT OF SUBJECTS 
6.1 
Identity of Study Vaccines 
The TAP-COVID-19 vaccine is comprised of a purified recombinant SARS-CoV-2 RBD-Fc 
conjugated to a TMV NtK carrier. The TAP-COVID-19 vaccine will be combined with CpG 7909 
adjuvant prior to administration. 
The product will be formulated and shipped as multi-dose vials. The vaccine doses will be diluted 
as appropriate by the site pharmacist to 15 μg or 45 μg doses of antigen along with 0.5 mg CpG 
adjuvant to be delivered in a single 0.5 mL IM injection. A detailed description for vaccine 
preparation is provided in the pharmacy manual. 
Buffered saline solution (with thimerosal) will be used as placebo. 
A description of the study vaccines is presented in Table 6-1. 
Table 6-1 
Study Vaccines 
Study Vaccine 
Dosage Form  
(Volume, Route) 
TAP-COVID-19 
Dose 
Manufacturer 
TAP-COVID-19 + CpG (0.5 mg) 
Injectable solution, (0.5 mL, 
intramuscular injection) 
15 μg 
Kentucky 
BioProcessing, Inc. 
TAP-COVID-19 + CpG (0.5 mg) 
Injectable solution, (0.5 mL, 
intramuscular injection) 
45 μg 
Kentucky 
BioProcessing, Inc. 
Placebo (buffered saline solution) 
Injectable solution, (0.5 mL, 
intramuscular injection) 
Not  
applicable 
Kentucky 
BioProcessing, Inc. 
TAP-COVID-19, CpG adjuvant, and the placebo (buffered saline solution) will be sourced by KBP.  
6.2 
Treatments Administered 
Both Part A (18-49 years) and Part B (50-85 years) will be randomized in a 2:1 ratio 
(active:placebo) for each treatment dose (15 μg and 45 μg TAP-COVID-19 vaccine + 0.5 mg CpG) 
for a total of 90 subjects per Part (30 subjects 15 μg TAP-COVID-19 vaccine + 0.5 mg CpG:30 
subjects 45 μg TAP-COVID-19 vaccine + 0.5 mg CpG:30 subjects placebo). 
Treatment A: TAP-COVID-19 vaccine (15 μg) + CpG (0.5 mg) IM injection on 
Day 1 and Day 22 (±3 days) 
Treatment B: TAP-COVID-19 vaccine (45 μg) + CpG (0.5 mg) IM injection on 
Day 1 and Day 22 (±3 days) 
Treatment C: Placebo (buffered saline solution) IM injection on Day 1 and Day 22 
(±3 days) 
The IM dose for Part C Expansion (optional) will be determined after reviewing the safety and 
immunogenicity data through Day 43 from Parts A and B (low and high dose).  
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6.3 
Method of Assigning Subjects to Treatment Groups 
ICON will prepare the randomization scheme in accordance with its SOPs and the randomization 
plan, which reflect GCP standards. Refer to Section 9.3 for a description of randomization 
methods. Eligible subjects will be assigned to a treatment group according to the list of subject 
randomization assignments. 
6.4 
Measurements of Treatment Compliance 
All study vaccine doses will be prepared and administered by delegated and trained staff at the 
clinical site(s). Details regarding dosing, including the dose administered and the date and time of 
dosing, will be recorded. 
6.5 
Study Vaccine Storage, Accountability, and Retention 
6.5.1 
Storage Conditions 
The Investigator will ensure that all the study vaccines are stored per the instructions 
accompanying the study vaccine. In addition, the Investigator will ensure that study vaccines are 
handled in accordance with the FDA regulations concerning the storage and administration of 
investigational products. 
Refer to the SRM for additional study vaccine storage instructions. 
6.5.2 
Drug Accountability and Retention 
The Investigator must ensure that all study vaccine supplies are kept in a secure locked area with 
access limited to those authorized by the Investigator. The Investigator must maintain accurate 
records of the receipt of all study vaccine shipped by KBP or their representative, including but 
not limited to the date received, lot number, expiration date, amount received, and the disposition 
of all study vaccine. Current dispensing records will also be maintained including the date and 
amount of study vaccine dispensed and the subject receiving the drug. All remaining study vaccine 
not required by regulations to be held by the clinical site(s) must be returned to KBP or their 
representative immediately after the study is completed. 
6.6 
Packaging and Labeling 
6.6.1 
Study Vaccine 
Study vaccine will be supplied as a concentrated injectable solution packaged in 10-mL multi-dose 
vials with preservative (thimerosal). CpG sterile solution will be supplied as a concentrated 
solution with preservative (thimerosal). Placebo will be buffered saline solution with preservative 
(thimerosal) provided by KBP.  

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6.6.2 
Blinding of Treatment Assignment 
ICON will maintain the randomization code in a secure location with controls to prevent 
unauthorized access, including the computer program written to generate the randomization, 
randomization codes, program log, seed number used by the program, copy of the randomization 
plan along with approval documentation as appropriate, and the write-protected electronic storage 
medium. 
The site and CRO will name an unblinded statistician to provide the randomization code. The 
pharmacists will be unblinded. Since the placebo and vaccine will not be identical in appearance, 
the staff member administering the doses will be unblinded and will not participate in any 
additional study activities. In order to preserve the blind, study vaccine will be prepared and 
administered in a manner that masks the content for both the subject and any observers. 
Investigators, site staff, subjects, CRO [except for the unblinded team members preparing the data 
for unblinded iSRC review] will remain blinded until the completion of the study. The Sponsor 
will remain blinded to individual subjects’ treatment assignment from the beginning of the study 
through Day 43. When the data is unblinded for the interim analysis after all subjects complete 
Day 43, the Sponsor will be unblinded   
6.6.3 
Unblinding of Treatment Assignment 
6.6.3.1 
Unblinding for Adverse Event/Safety Reasons 
Should an SAE or other circumstance require that the blind be broken to ensure subject safety, the 
Investigator must immediately notify the medical monitor and/or Sponsor. ICON/designee will 
notify the Sponsor as soon as possible and will release the treatment assignment of the subject to 
the appropriate personnel in accordance with the applicable SSP. 
If the treatment assignment is unblinded by the site pharmacist or any party other than ICON, the 
Investigator must notify ICON in writing and document the course of events in the source records. 
Any subject for whom the treatment code is prematurely released will be withdrawn from the 
study. 
6.6.3.2 
Unblinding for Interim Analyses 
An unblinded interim analysis will be performed on the safety and immunogenicity data collected 
for each of the 4 dose groups (Part A low dose, Part A high dose, Part B low dose, and Part B high 
dose). Unblinded interim analysis will occur for the Part A low dose group (including active and 
placebo subjects) when the first 30 subjects vaccinated have data available from Day 1 through 
Day 43. The remaining cohorts will have an unblinded interim analysis performed when all 
subjects in the cohort have data from Day 1 through Day 43. For the interim analysis, treatment 
codes will be unblinded after the data are deemed ready for the analysis and the data has been 
monitored The CRO [except for the unblinded team members preparing the data for unblinded 
iSRC review], Investigator, and clinical staff will not have access to the unblinded treatment group 
interim analyses and will remain blinded until completion of the study. The Sponsor will be 
unblinded at the interim analysis. The iSRC will communicate immunogenicity data to the study 
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authorized.
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team in a blinded manner so that clinical development decisions for additional studies can be made 
by the Sponsor. 
6.7 
Concomitant Medications and Procedures and Other Restrictions 
6.7.1 
Concomitant Medications and Procedures 
Any medication taken by a subject from 30 days prior to the screening visit through the first 
43 days of the study and the reason for its use will be documented. 
Previous prescription medication for mild chronic health disorders (eg, hypertension or 
hypercholesterolemia) or maintenance (eg, contraception) will be allowed at the discretion of the 
Investigator as long as the subject has been on a stable dose for at least 3 months. Subjects should 
continue their regular maintenance medications throughout study participation unless instructed to 
discontinue or change by the Investigator or their personal physician. If concomitant medications 
are discontinued by a subject during study conduct the subject should notify the Investigator. 
Subjects should refrain from starting new medications, modifying current concomitant 
medications, or receiving vaccinations during study participation unless prescribed by the 
Investigator for treatment of specific clinical events. 
Subjects should not receive any vaccine within 1 month before screening. 
Subjects should not be using prescription medications for the prophylaxis of SARS-CoV-2. 
Subjects should not participate or plan to participate in a study that involves an experimental agent 
(vaccine, drug, biologic, device, or medication); or should not have received an experimental agent 
within 1 month before enrollment in this study; or who expect to receive another experimental 
agent during participation in this study. 
A positive drug screen result with a corresponding prescribed concomitant medication will be 
allowed if, in the opinion of the investigator and Medical Monitor, the concomitant medication 
does not make the subject unsuitable to participate in the clinical trial. 
6.7.2 
Other Restrictions 
Subjects will be instructed to adhere to the following restrictions: 
 Strenuous activity (as assessed by the Investigator) is prohibited from 48 hours prior to the 
days safety laboratory blood will be collected 
 Subjects are not permitted to consume alcohol for 3 days prior to vaccination and should 
refrain from consumption of alcohol until 7 days post vaccination. 
 Subjects should refrain from blood donation for 6 months post vaccination. 
 Subjects should not participate or plan to participate in a study that involves an 
experimental agent (vaccine, drug, biologic, device, or medication); or should not have 
received an experimental agent within 1 month before enrollment in this study; or who 
expect to receive another experimental agent during participation in this study. 

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7 
STUDY ASSESSMENTS AND PROCEDURES 
Subjects will undergo study procedures and assessments at time points specified in the Schedule 
of Assessments and Procedures (Table 1-1). 
7.1 
Pandemic Safety Procedures 
Appropriate measures will be taken to ensure the safety of both study staff and study subjects 
including social distancing and appropriate personal protective equipment. 
7.2 
Medical and Surgical History 
The Investigator or designee will collect a complete medical and surgical history at screening. 
Medical and surgical history will be collected at CRU visits to determine if any changes have 
occurred since screening. 
7.3 
Demographic Characteristics 
Demographic characteristics including sex, age, race, and ethnicity will be recorded. Tobacco use 
and history will also be documented. 
7.4 
Physical Measurements 
Height (cm) and body weight (kg) without shoes will be recorded. BMI will be calculated using 
the height obtained at screening. 
7.5 
Immunogenicity 
Blood samples for antibody titers will be collected per Table 1-1 to assess: 
 Vaccine (ELISA for IgM and IgG, total antibody) and neutralizing antibody titers (virus 
microneutralization) for each treatment group: 
o GMT ratio (GMTplacebo/GMTTAP-COVID-19)  
o Seroconversion rate is defined as the proportion of subjects at the respective time 
point that have detectable antibodies (IgG and IgM) against SARS-CoV-2 Spike 
Protein RBD following challenge with vaccine (and potentially by natural 
asymptomatic or symptomatic infection by the virus in case of a placebo subject).  
 Anti-RBD and anti-Fc antibodies 
Blood samples for cellular immunity (PBMCs) will be collected per Table 1-1. The numbers of 
cytokine producing CD4+ and CD8+ T-cells from PBMCs responsive to vaccine antigens will be 
analyzed using a validated procedure. 
PBMC and serum samples for future research will also be collected (5-7 aliquots [1 mL]) at the 
time points outlined in Table 1-1. 
Immunogenicity sample collection, processing, and shipping details will be outlined in a separate 
SRM. 
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7.6 
SARS-CoV-2 Exposure and Asymptomatic Monitoring  
Subjects will be monitored for SARS-CoV-2 exposure for potential asymptomatic infection 
throughout the study. CRU staff will interview subjects about any potential exposure to the virus. 
If a subject has had potential exposure, the CRU will perform an unscheduled nasopharyngeal 
swab. Subjects will not be discontinued from the study due to positive SARS-CoV-2 test results. 
 If a subject has a positive or borderline ELISA anti-N IgG result, sites should have the 
subject return for an unscheduled PCR. If the ELISA is positive and the PCR is negative, 
the sites should follow the subjects using the standard of care under Investigator discretion, 
retesting ELISA at the next study visit(s) or sooner (per the Investigator’s decision). 
 If the subject has a positive or borderline ELISA anti-N IgG AND a positive PCR test, the 
clinical sites should bring the subjects back for repeat PCR testing as described below. 
 The clinical sites should continue to collect PCR tests if a subject is experiencing possible 
COVID-19 symptoms, or had possible exposure to SARS-CoV-2 (ie, close contact tests 
positive for SARS-CoV-2). Testing will occur every 2 weeks for a total of 4 weeks (if 
2 consecutive negative tests) or until negative (x2) after a positive result. Positive results 
will be reported as an AESI (Section 8.2.2) and subjects followed for disease severity, 
duration, and outcome. 
Telephone visits will be conducted to augment the in person visits through 6 months post-
vaccination (Table 1-1). CRU staff will interview the subjects about any potential exposure to the 
virus. If a subject has had potential exposure, the CRU will ask the subject to come in for an 
unscheduled visit that will include a nasopharyngeal swab.  
Subjects will be reminded at onsite visits and during telephone visits to contact the clinical site 
any time there is potential exposure to SARS-CoV-2 or they are experiencing any respiratory 
disease/symptoms suggestive of SARS-CoV-2 infection.  
7.7 
Safety Assessments 
7.7.1 
Adverse Events 
Subjects will be monitored for AEs according to Section 8. 
If a subject experiences respiratory symptoms suggestive of SARS-CoV-2 infection, the subject 
should notify the clinical site for a visit to collect nasopharyngeal swabs for RT-PCR virus 
detection. 
Subjects with positive ELISA anti-N IgG results without COVID-19 symptoms may indicate 
asymptomatic SARS-CoV-2 infection and will be followed with the appropriate standard of care. 
Subjects with a positive ELISA anti-N IgG result should have a PCR test and be followed until 
both are negative as in the protocol instructions (Section 7.6). 
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7.7.2 
Reactogenicity Assessments 
Subjects will keep a Diary Card to track reactogenicity assessments for 7 days after each 
vaccination. Reactogenicity assessments include generalized symptoms such as headache, fatigue, 
muscle pain, joint pain, nausea, chills, fever, and rash (not at injection site), and localized reactions 
including pain, erythema, induration, and swelling. If an AE continues after 7 days, the AE will be 
captured as ongoing/continuing (not noted as a new AE).  
7.7.3 
Laboratory Tests 
A certified laboratory will be utilized to process and provide results for the clinical safety 
laboratory tests listed in Table 7-1. The baseline laboratory test results for clinical assessment for 
a particular test will be defined as the last measurement prior to the first dose of study vaccine. 
Subjects will fast a minimum of 8 hours prior to clinical laboratory sample collection at screening. 
During the screening period, if a subject has an out-of-range value for a clinical safety laboratory 
parameter that the Investigator believes is not clinically significant or the Investigator does not 
believe is correct (eg, lab or specimen processing error), but the Investigator wants to confirm with 
a repeat laboratory test, a single repeat is allowed to confirm the initial result. 
If Part C Expansion (optional) is performed, all Part C subjects will have safety laboratory tests 
performed at screening only in order to satisfy the inclusion/exclusion criteria. In addition, the first 
200 subject in Part C will have safety laboratory tests performed at all time points. The remaining 
subjects in Part C will not have safety laboratory tests performed at any of the post-dose time 
points unless the Investigator deems it necessary.  
Additional safety laboratory tests may be conducted as needed by the Investigator to evaluate 
subject safety. 
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Table 7-1 
Clinical Safety Laboratory and Screening Tests 
Hematology 
Chemistry 
Urinalysis 
Hematocrit 
Hemoglobin 
Red blood cell count 
White blood cell count 
Neutrophils (absolute) 
Lymphocytes (absolute) 
Monocytes (absolute) 
Basophils (absolute) 
Eosinophils (absolute) 
Platelet count (estimate 
not acceptable) 
Albumin 
Alkaline phosphatase 
Alanine 
aminotransferase 
Aspartate 
aminotransferase 
Gamma glutamyl 
transferase 
Direct bilirubin 
Total bilirubin 
Lactate dehydrogenase 
Total protein 
Blood urea nitrogen 
Creatinine 
Calcium 
Phosphate 
Sodium 
Potassium 
Carbon dioxide 
Chloride 
Glucose a 
Total cholesterol 
Triglycerides a 
Specific gravity 
Ketones 
pH 
Protein 
Blood 
Glucose 
Leukocyte esterase 
Microscopic analysis (performed if 
blood, leukocytes, or protein are 
present) 
Urine Drugs of 
Abuseb,c 
Serology d 
Other 
 
Barbiturates 
Cocaine 
Tetrahydrocannabinol 
Amphetamines 
Opiates 
Phencyclidine 
HIV-1 
HIV-2 
HBsAg 
HCV antibody 
Prothrombin 
Pregnancy test 
Follicle-stimulating 
hormone e 
Alcohol screenc 
 
a. 
Fasting required at screening only 
b. At a minimum, these tests must be included 
c. 
During the screening period, urine drugs of abuse and alcohol screens may not be repeated for eligibility 
d. Includes any confirmatory tests performed at the discretion of the Investigator 
e. 
As needed to confirm postmenopausal status 
For any laboratory test value outside the reference range that the Investigator considers clinically 
significant during the on-study period (ie, following dose administration), the Investigator will: 
 Repeat the test to verify the out-of-range value and clinical significance. 
 Follow the out-of-range value until the value returns to normal or baseline, or until the value 
is deemed stable and not clinically significant by the Investigator. 
 Record as an AE any laboratory test value that is confirmed by repeat and the Investigator 
considers clinically significant, requires a subject to be discontinued from the study, requires 
a subject to receive treatment, or requires a change or discontinuation of the study vaccine 
(if applicable). 
7.7.4 
Vital Signs 
Vital signs assessments will include systolic and diastolic blood pressure (mmHg), heart rate 
(bpm), respiratory rate (breaths per minute), and oral temperature (C°). In addition, oral 
temperature will be performed prior to each vaccination. Vital signs will be measured after the 
subject has been resting quietly in a seated position for at least 5 minutes. Any clinically significant 
abnormal vital sign assessment requires at least one repeat measurement. 

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A vital signs abnormality that is considered clinically significant initially and on confirmation, 
requires a subject to be discontinued from the study, requires a subject to receive treatment, or 
requires discontinuation from the study vaccine (if applicable) will be recorded as an AE. 
7.7.5 
Physical Examination 
Comprehensive physical examinations (excluding genital, rectal, and breast examinations [unless 
indicated]) will be performed, and abnormal findings will be documented in the subject’s eCRF. 
Targeted physical examinations will focus on any AEs ongoing at the time of the examination 
(Table 1-1). 
An abnormal physical examination finding that is considered clinically significant and requires the 
subject to be discontinued from the study, requires the subject to receive treatment, or requires 
discontinuation of the study vaccine (if applicable) will be recorded as an AE. 
7.7.6 
Appropriateness of Safety Assessments 
Safety evaluations selected for this study are typical of those for this subject population and utilize 
widely accepted measures. 
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8 
ADVERSE EVENTS 
An AE is defined as any untoward medical occurrence in a subject administered a pharmaceutical 
product during the course of a clinical investigation. An AE can therefore be any unfavorable and 
unintended sign, symptom, or disease temporally associated with the use of a study vaccine, 
whether or not thought to be related to the study vaccine. A TEAE is any AE that occurs after the 
first dose of study drug, regardless of relationship to the study drug. 
MAAEs are AEs for which the subject has received medical attention by medical personnel, or in 
an emergency room, or which led to hospitalization. For each reported AE, the Investigator will 
ask the subject if such medical attention has been received. In addition, the Investigator will assess 
each MAAE if it constitutes a NOCD, defined as a MAAE that was:  
 absent at baseline,  
 not resolved at EOS  
 required continuous medical care or attention. 
Subjects will be monitored throughout the study for AEs, from the first dose of study vaccine 
through Day 43 of the study and for SAEs, MAAEs, NOCDs, and AESIs from the first dose 
through the end of the study (Day 365 ±14 days). Adverse events that are identified at the last 
assessment visit (or the early termination visit) as specified in the protocol must be recorded on 
the AE eCRF with the status of the AE noted. All events that are ongoing at this time will be 
recorded as ongoing on the eCRF. All (both serious and nonserious) AEs must be followed until 
they are resolved or medically stable, or until reasonable attempts to determine resolution of the 
event are exhausted. The Investigator should use his/her discretion in ordering additional tests as 
necessary to monitor the resolution of such events. 
The procedures specified in Section 8.4 are to be followed for reporting SAEs. 
8.1 
Recording Adverse Events 
Adverse events are to be recorded on the AE page of the eCRF. The following information will be 
recorded:  
 Assessment of whether or not the AE is an SAE, MAAE, NOCD, or AESI (Section 8.2.1) 
 Assessment of AE intensity (Section 8.2.2) 
 Assessment of AE relationship to study vaccine (Section 8.2.4) 
 Action taken - dose not changed, vaccine dose 2 not given, not applicable, or unknown, 
as applicable 
 Outcome - recorded as fatal, not recovered/not resolved, recovered/resolved, 
recovered/resolved with sequelae, recovering/resolving, or unknown, as applicable 

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8.2 
Assessment of Adverse Events 
The Investigator will assess each AE for seriousness, intensity, and relationship to study vaccine. 
8.2.1 
Serious Adverse Events, Medically Attended Adverse Events, New Onset 
Chronic Medical Conditions, Adverse Events of Special Interest, and 
Potential Immune-mediated Conditions 
The Investigator is responsible for determining whether an AE meets the definition of an SAE, 
MAAE, NOCDs, or AESIs including potential immune-mediated medical condition from the first 
dose of the study vaccine through the end of the study (Day 365 ±14 days).  
An SAE is any AE that results in any of the following outcomes: 
 Death 
 A life-threatening adverse drug experience 
 Inpatient hospitalization or prolongation of existing hospitalization 
 A persistent or significant disability/incapacity 
 A congenital anomaly/birth defect 
Important medical events that may not result in death, be life threatening, or require hospitalization 
may be considered an SAE when, based upon appropriate medical judgment, they may jeopardize 
the subject and may require medical or surgical intervention to prevent any of the outcomes listed 
in this definition. Examples of such medical events include allergic bronchospasm requiring 
intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not 
result in inpatient hospitalization, or the development of drug dependency or drug abuse. 
MAAEs are defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit 
to or from medical personnel for any reason. 
NOCDs are defined as any new ICD diagnosis (per current International Statistical Classification 
of Diseases and Related Health Problems) that is applied to the subject during the course of the 
study, after receipt of the study agent, that is expected to continue for at least 3 months and requires 
continued health care intervention. 
AESIs are defined in Section 8.2.2 and a list of potential immune-mediated medical conditions is 
provided in Appendix B. 
Note: SAEs, MAAEs, NOCDs, and AESIs including potential immune-mediated medical 
conditions require immediate reporting to the medical monitor and/or Sponsor. Refer to 
Section 8.4 for details. 
8.2.2 
Adverse Events of Special Interest 
An AESI is any AE that a regulatory authority has mandated be reported on an expedited basis 
(including to the iSRC), regardless of the seriousness, expectedness, or relatedness of the AE to 

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the administration of investigational product. To date, no AESIs have been identified specifically 
for the TAP-COVID-19 vaccine + CpG adjuvant. However, subjects who test positive for 
COVID-19, present with autoimmune disease, or are diagnosed with a potential immune-mediated 
medical condition (Appendix B) should be reported as AESI.  
AESIs will be followed as per the procedures in the study protocol, SRM, and/or SAE SSP for 
SAEs and pregnancy reporting, regardless of the seriousness, expectedness, or relatedness of the 
AESI to the administration of study vaccine. AESIs will be reported by the site directly to the 
Sponsor, medical monitor, and SAE hotline at ICON (ICON Pharmacovigilance) (Section 8.4). 
Subjects positive for SARS-CoV-2 will not be discontinued. Positive SARS-CoV-2 cases will be 
followed and include referral to a primary care physician, collection of all medical records, 
assessment of severity, and review by the site investigator and medical monitor. All positive 
SARS-CoV-2 cases will also be shared with the iSRC on an ongoing basis. 
8.2.3 
Intensity 
The intensity of an AE will be graded according to Guidance for Industry: Toxicity Grading Scale 
for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials 
(September 2007). The grading scale is comprised of 4 levels: mild (Grade 1), moderate (Grade 2), 
severe (Grade 3), and potentially life-threatening (Grade 4). For those AEs that are not covered in 
the Guidance for Industry (above) the rating scale from DAIDS (Table for Grading the Severity of 
Adult and Pediatric Adverse Events, Version 2.1) will be used (Table 8-1). 
Table 8-1 
DAIDS Adverse Events Intensity Assessment 
Grade 
Intensity 
Definition 
Grade 1 
Mild 
Symptoms causing no or minimal interference with usual social and 
functional activities with intervention not indicated. 
Grade 2 
Moderate 
Symptoms causing greater than minimal interference with usual social 
and functional activities with intervention indicated. 
Grade 3 
Severe 
Symptoms causing inability to perform usual social and functional 
activities with intervention or hospitalization indicated. 
Grade 4 
Potentially  
Life-Threatening 
Symptoms causing inability to perform basic self-care functions with 
intervention indicated to prevent permanent impairment, persistent 
disability, or death. 
Grade 5 
 
Any AE where the outcome is death 
8.2.4 
Relationship to Study Vaccine 
The relationship of an AE to the study vaccine should be determined by the Investigator according 
to the following criteria: 
 Not related: The event is most likely produced by other factors such as the subject’s clinical 
condition, intercurrent illness, or concomitant drugs, and does not follow a known response 
pattern to the study vaccine, or the temporal relationship of the event to study vaccine 
administration makes a causal relationship unlikely 
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 Related: The event follows a reasonable temporal sequence from the time of drug 
administration, and/or follows a known response pattern to the study vaccine, and cannot 
be reasonably explained by other factors such as the subject's clinical condition, 
intercurrent illness, or concomitant drugs 
8.3 
Discontinuation Due to Adverse Events 
Any subject who experiences an AE may be withdrawn at any time from the study at the discretion 
of the Investigator. Subjects withdrawn from the study due to an AE, whether serious or 
nonserious, may be followed by the Investigator until the clinical outcome of the AE is determined. 
The subject will also be asked to participate in a Follow-up Visit at approximately Day 365 to 
check safety and immunogenicity. The AE(s) should be noted on the appropriate eCRFs, the 
subject’s progress should be followed until the AE is resolved or medically stable as determined 
by the Investigator, and the Sponsor notified.  
8.4 
Reporting Serious Adverse Events and Adverse Events of Special Interest 
In the event of any SAE or AESI reported or observed during the study, whether or not attributable 
to the study vaccine, site personnel will report it immediately by telephone to the Sponsor, medical 
monitor, AND SAE hotline at ICON (ICON Pharmacovigilance) in accordance with procedures 
described in the SRM and/or SAE SSP. Site personnel will follow up with a written report on the 
next working day. 
Report Forms will be provided to the CRU to assist in collecting, organizing, and reporting SAEs 
or AESIs and follow-up information. 
All SAEs and AESIs should be followed to their resolution, with documentation provided to the 
Sponsor/ICON on a follow-up Report Form. 
8.5 
Pregnancy 
Pregnancies will be captured if they occur in female subjects from the time the subject is first 
exposed to the study vaccine until EOS. Pregnancies in the sexual partners of male subjects will 
be captured from the time the subject is first exposed to the study vaccine until 90 days after last 
exposure to the study vaccine. 
Female subjects must be instructed to inform the study Investigator immediately if they become 
pregnant during the study. 
The Investigator must report any pregnancy to the medical monitor, Sponsor, and ICON 
Pharmacovigilance within 1 business day of becoming aware of the pregnancy per pregnancy 
reporting procedures described in the SRM. The subject must be immediately discontinued from 
further treatment with study vaccine. An uncomplicated pregnancy will not be considered an AE 
or SAE; however, all pregnancies will be followed through birth and 3 months postdelivery. 
Any congenital abnormalities in the offspring of a subject who received study vaccine will be 
reported as an SAE. The outcome of any pregnancy and the presence or absence of any congenital 

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abnormality will be recorded in the source documentation and reported to the Sponsor and ICON 
Pharmacovigilance. 
8.6 
Drug-induced Liver Injury 
Subjects will be monitored for signs of DILI. Study vaccine (dose 2) will be withheld in the event 
of potential DILI. 
Potential events of DILI will be defined as meeting all of the following criteria (as specified in the 
FDA Guidance for Industry Drug-induced Liver Injury: Premarketing Clinical Evaluation, 2009): 
 ALT or AST >3 × ULN 
 Total bilirubin >2 × ULN without initial findings of cholestasis (elevated serum ALP) 
 No other reason can be found to explain the combination of laboratory value increases 
(eg, acute viral hepatitis; alcoholic and autoimmune hepatitis; hepatobiliary disorders; 
nonalcoholic steatohepatitis; cardiovascular causes; concomitant treatments) 
Potential events of DILI will be reported as SAEs (Section 8.4). All subjects with potential DILI 
will be closely followed until abnormalities return to normal or baseline or until reasonable 
attempts to determine resolution of the event are exhausted. 
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9 
STATISTICAL CONSIDERATIONS 
The statistical analysis will be conducted following the principles as specified in ICH Topic E9 
(CPMP/ICH/363/96). 
All statistical analyses will be described in a separate SAP. 
The statistical evaluation will be performed using SAS® software version 9.4 or higher (SAS 
Institute, Cary, NC). All data will be listed, and summary tables will be provided. No formal 
significance testing will be performed. Summary statistics will be presented by treatment group 
and include subset analysis (eg, all subjects, seronegative subjects [ie, neutralizing antibody titer 
< 10 at screening], seropositive subjects, and subjects that received an FDA Emergency Use 
Authorization/licensed COVID vaccine). For continuous variables, data will be summarized with 
the number of subjects, mean, standard deviation, median, minimum, maximum, geometric mean, 
CV%, GeoCV%, and 95% CI by treatment group. For categorical variables, data will be tabulated 
with the number and proportion of subjects for each category by treatment group.  
The database will be locked and unblinded after the data have been monitored for all subjects 
through Day 43. Details of the unblinded interim analysis are presented in Section 9.5. 
The final analysis of the safety and immunogenicity data collected from Day 43 through 
Day 365/approximately 1 year after first vaccination will be performed after the study is 
completed. An addendum to the initial CSR will be prepared with data from final analysis. Details 
of the statistical analyses, methods, and data conventions will be described in the SAP.  
9.1 
Sample Size Calculation 
No formal sample size calculation was performed.  
A total of 180 subjects will be enrolled in Parts A and B. Approximately 90 eligible subjects (aged 
18-49 years), with 30 subjects per treatment group for Part A and 90 eligible subjects (aged 
50-85 years), with 30 subjects per treatment group for Part B, will be enrolled in the study.  
An optional Part C Expansion may be conducted to confirm the safety and immunogenicity of the 
selected dose of vaccine in up to 1000 adult subjects randomized 1:1 (single dose level of study 
vaccine:placebo). The proposed sample size was selected based on WHO guidelines on clinical 
evaluation of vaccines: regulatory expectations Annex I (2001), which states that approximately 
300 subjects are needed to identify common local reactogenicity events. A larger sample size will 
assist in a better characterization of kinetics and range of immunity (neutralizing antibody titers) 
and provide a more reliable output of seropositivity and seroconversion to TAP-COVID-19 
immunization. With the limited clinical experience with SARS-CoV-2 vaccines and the current 
lack of a biomarker correlate of protection, the generation of this larger data set is relevant to 
inform the design and implementation of a Phase 3 program. 
9.2 
Analysis Populations 
Enrolled Population: All subjects who signed the ICF. 
Deleted: statistical analysis plan
Deleted: .
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Deleted: statistical analysis plan. 
Deleted: An iSRC will be established by the Sponsor to monitor 
overall study conduct and to review accumulating safety data 
including immunogenicity at Day 43 for Part A and for Part B in 
both dose groups and throughout the study. The iSRC will also 
convene to monitor any Study Halting Rules or safety issues. ¶
Deleted: were screened and enrolled to
Deleted: study. The Enrolled Population will include all screen 
failures and all subjects who are discontinued from the study prior to 
study vaccine administration and will be used for disposition 
summaries

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Safety Population: All subjects who provide consent, are randomized, and receive any amount of 
study vaccine/placebo. The Safety Population will be used for the demographic, baseline 
characteristic, safety data summaries, and the analysis of primary endpoints such as occurrence of 
solicited local and systemic reactogenicity. 
Per Protocol (PP) Population: Includes all subjects in the Safety Population who receive the 
assigned doses of the study vaccine/placebo according to protocol, have serology results, and have 
no major protocol deviations affecting the primary immunogenicity outcomes, as determined by 
the Sponsor before database lock and unblinding. Subjects that are immunized with an approved 
vaccine will be captured as a subset analysis of the PP Population at Days 90, 181, 273, and 365 
based on the date of receiving an approved COVID-19 vaccine. 
Modified Intent-to-Treat (mITT) Population: Includes all subjects in the Safety Population who 
provide any serology data. The mITT Population will be used for the immunogenicity analysis.  
9.3 
Randomization 
The overall randomization for the study will be 2:1 (active:placebo). Each Part (A and B) and 
treatment (low and high) will be randomized individually 2:1 (active to placebo).  
The study will start with Part A (18-49 years) low dose, randomized in a 2:1 ratio (30 subjects 
active:15 subjects placebo) for Treatment A (15 μg TAP-COVID-19 vaccine + 0.5 mg CpG). 
Part A (18-49 years) high dose will be randomized in a 2:1 ratio (30 subjects active:15 subjects 
placebo) for Treatment B (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG) after Part A low dose 
has completed enrollment and the iSRC has reviewed safety and tolerability data through Day 8. 
Part B (50-85 years) low dose will be randomized in a 2:1 ratio (30 subjects active:15 subjects 
placebo) for Treatment A (15 μg TAP-COVID-19 vaccine + 0.5 mg CpG) after Part A low dose 
has completed enrollment and received the first vaccination and the iSRC has reviewed safety data 
through Day 8. 
Part B (50-85 years) high dose will be randomized in a 2:1 ratio (30 subjects active:15 subjects 
placebo) for Treatment B (45 μg TAP-COVID-19 vaccine + 0.5 mg CpG) after Part B low dose 
has completed enrollment and received the first vaccination and the iSRC has reviewed safety data 
through Day 8. 
A total of 90 subjects will be randomized in Part A (18-49 years); 30 subjects low dose (Treatment 
A, 15 μg TAP-COVID-19 vaccine + 0.5 mg CpG), 30 subjects high dose (Treatment B, 45 μg 
TAP-COVID-19 vaccine + 0.5 mg CpG), and 30 subjects placebo (Treatment C). 
A total of 90 subjects will be randomized in Part B (50-85 years); 30 subjects low dose (Treatment 
A, 15 μg TAP-COVID-19 vaccine + 0.5 mg CpG), 30 subjects high dose (Treatment B, 45 μg 
TAP-COVID-19 vaccine + 0.5 mg CpG), and 30 subjects placebo (Treatment C). 
Treatment A: TAP-COVID-19 vaccine (15 μg) + CpG (0.5 mg) IM injection on 
Day 1 and Day 22 (±3 days) 
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Treatment B: TAP-COVID-19 vaccine (45 μg) + CpG (0.5 mg) IM injection on 
Day 1 and Day 22 (±3 days) 
Treatment C: Placebo (buffered saline solution) IM injection on Day 1 and Day 22 
(±3 days) 
A computer-generated randomization schedule for each part (Part A, Part B, and Part C Expansion) 
will be generated prior to study start by an ICON biostatistician. 
For sentinel dosing, 3 subjects from each part will be randomized 2:1 (active:placebo). The 
remainder of each cohort will also be randomized 2:1 (active:placebo).  
9.4 
Endpoints 
Endpoints are presented in Section 3.2. 
9.5 
Interim Analyses 
An unblinded interim analysis will be performed on the safety and immunogenicity data 
collected for each of the 4 dose groups (Part A low dose, Part A high dose, Part B low dose, and 
Part B high dose). Unblinded interim analysis will occur for the Part A low dose group 
(including active and placebo subjects) when the first 30 subjects vaccinated have data available 
from Day 1 through Day 43. The remaining cohorts will have an unblinded interim analysis 
performed when all subjects in the cohort have data from Day 1 through Day 43. For the interim 
analysis, treatment codes will be unblinded after the data are deemed ready for the analysis and 
the data has been monitored. The CRO [except for the unblinded team members preparing the 
data for unblinded iSRC review], Investigator, and clinical staff will not have access to the 
unblinded treatment group interim analyses and will remain blinded until completion of the 
study. The Sponsor will be unblinded at the interim analysis. Safety and immunogenicity 
analyses from this unblinded interim analysis will be presented in a CSR. This CSR may be 
submitted to regulatory authorities as needed.  
9.6 
Immunogenicity Analysis 
The mITT Population will be used for all listings and summary statistics corresponding to 
immunogenicity analysis.  
The individual sampling and blood collection for ELISA analysis to determine IgG and IgM 
antibody titers to the spike RBD and neutralizing antibody titers for parent (Wuhan) and any 
variant SARS-CoV-2 strains, will be listed and summarized by time points for each part by 
treatment.  
All derived immunogenicity secondary endpoint parameters: GMT, GMT ratio, GMFR, GMI, and 
seroconversion rates will be listed and summarized by scheduled time point using descriptive 
statistics (n, mean, SD, minimum, median, maximum, geometric mean, CV%, GeoCV%, and 95% 
CI) for each part by treatment. 
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PBMC and serum sample data for future research results at each scheduled visit will also be 
provided separately in a listing and summary table, if applicable. 
Subgroup analysis for safety and efficacy will be performed for those subjects who were 
seropositive when enrolled. 
Graphical display of the summary results or at individual time points will be provided as needed 
(eg, scatter plots of subject titer values to visually display individual data points). 
Additional details for analysis of immunogenicity are presented in the SAP. 
9.7 
Cellular Analysis 
The number of IFN- and IL-5 producing T-cells (CD4+ and CD8+) from PBMCs responsive to 
vaccine antigens will be listed and summarized by time point using appropriate descriptive 
statistics for each part by treatment. 
Additional details for cellular analysis are presented in the SAP. 
9.8 
Safety Analysis 
Safety Population will be used for all safety variables specified.  
All safety data will be summarized by part and treatment. No statistical tests will be performed. 
Subjects who are seropositive and seronegative at screening will also be summarized and safety 
and efficacy subgroup analysis will be performed for these groups of subjects. 
Additional details for safety analysis are presented in the SAP. 
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10 
ACCESS TO SOURCE DATA/DOCUMENTS 
The Investigator will provide direct access to source data and documents for individuals 
conducting study-related monitoring, audits, IRB review, and regulatory review. The Investigator 
must inform the study subject that his/her study-related records may be reviewed by the above 
individuals without violating the subject’s privacy of personal health information in compliance 
with HIPAA regulations. 
Attention is drawn to the regulations promulgated by the FDA under the Freedom of Information 
Act providing, in part, that information furnished to clinical Investigators and IRBs will be kept 
confidential by the FDA only if maintained in confidence by the clinical Investigator and IRB. By 
signing this protocol, the Investigator affirms to the Sponsor that the Investigator will maintain, in 
confidence, information furnished to him or her by the Sponsor and will divulge such information 
to the IRB under an appropriate understanding of confidentiality with such board. 

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11 
QUALITY CONTROL AND QUALITY ASSURANCE 
Sponsor/ICON will implement and maintain quality control and quality assurance procedures with 
written SOPs to ensure the study is conducted and data are generated, documented, and reported 
in compliance with the protocol, GCP, and applicable regulatory requirements. 
11.1 
Conduct of Study 
This study will be conducted in accordance with the provisions of the Declaration of Helsinki and 
all revisions thereof (Tokyo 2004), and in accordance with FDA CFR (§312.50 and §312.56) and 
the ICH E6 Guidelines on GCP (CPMP/ICH/135/95). Specifically, this study is based on 
adequately performed laboratory and animal experimentation; the study will be conducted under 
a protocol reviewed by an IRB; the study will be conducted by scientifically and medically 
qualified persons; the benefits of the study are in proportion to the risks; the rights and welfare of 
the subjects will be respected; the physicians conducting the study do not find the hazards to 
outweigh the potential benefits; and each subject will give his or her written, informed consent 
before any protocol-driven tests or evaluations are performed. 
The Investigator may not deviate from the protocol without a formal protocol amendment having 
been established and approved by an appropriate IRB, except when necessary to eliminate 
immediate hazards to the subject or when the change(s) involve only logistical or administrative 
aspects of the study and are approved by the Sponsor. Any deviation may result in the subject 
having to be withdrawn from the study, and may render that subject nonevaluable. 
11.1.1 
Protocol Deviations 
A protocol deviation is defined as any intentional or unintentional change to, or noncompliance 
with, the approved protocol procedures or requirements. Deviations may result from the action or 
inaction of the subject, Investigator, or site staff. 
At the outset of the study, a process for defining and handling protocol deviations will be 
established. This will include determining which violations will be designated “key,” requiring 
immediate notification to the medical monitor and/or Sponsor. The Investigator is responsible for 
seeing that any known protocol deviations are recorded and handled as agreed. 
11.2 
Protocol Amendments 
Only the Sponsor may modify the protocol. Amendments to the protocol will be made only after 
consultation and agreement between the Sponsor and the Investigator. All amendments that have 
an impact on subject risk or the study objectives, or require revision of the ICF, must receive 
approval from the IRB prior to their implementation.  
11.3 
Monitoring of Study 
The Investigator will permit the CRA to review study data as frequently as is deemed necessary to 
ensure data are being recorded in an adequate manner and protocol adherence is satisfactory. 

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The Investigator will provide access to medical records for the monitor to verify eCRF entries. 
The Investigator is expected to cooperate with the Sponsor or a designee in ensuring the study 
adheres to GCP requirements. 
The Investigator may not recruit subjects into the study until the Sponsor or a designee has 
conducted a site initiation visit (in-person or via teleconference) to review the protocol and eCRF 
in detail. 

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12 
ETHICS 
12.1 
Institutional Review Board Approval 
12.1.1 
Ethics Review Prior to Study 
The Investigator will ensure that the protocol and ICF are reviewed and approved by the 
appropriate IRB prior to the start of any study procedures. The IRB will be appropriately 
constituted and will perform its functions in accordance with FDA regulations, ICH GCP 
guidelines, and local requirements as applicable. 
12.1.2 
Ethics Review of Other Documents 
The IRB will approve all protocol amendments (except for Sponsor-approved logistical or 
administrative changes), written informed consent documents and document updates, subject 
recruitment procedures, written information to be provided to the subjects, available safety 
information, information about payment and compensation available to subjects, the Investigator’s 
curriculum vitae and/or other evidence of qualifications, and any other documents requested by 
the IRB and regulatory authority as applicable. 
12.2 
Written Informed Consent 
The nature and purpose of the study will be fully explained to each subject. The subjects must be 
given ample time and opportunity to inquire about details of the study, to have questions answered 
to their satisfaction, and to decide whether to participate. Written informed consent must be 
obtained from each subject prior to any study procedures being performed. 

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13 
DATA HANDLING AND RECORD KEEPING 
13.1 
Data Reporting and Case Report Forms 
13.1.1 
Case Report Forms 
The Investigator will be provided with eCRFs, and will ensure all data from subject visits are 
promptly entered into the eCRFs in accordance with the specific instructions given. The 
Investigator must sign the eCRFs to verify the integrity of the data recorded. 
13.1.2 
Laboratory Data 
A list of the normal ranges for all laboratory tests to be undertaken forms part of the documentation 
to be collated prior to study start. If a central laboratory has been selected to conduct any or all 
tests, it is essential all samples be analyzed at that laboratory. The Investigator must maintain 
source documents such as laboratory reports and complete history and physical examination 
reports. 
13.1.3 
Retention of Source Documents 
The Investigator must maintain source documents such as laboratory reports, x-rays, ECGs, 
consultation reports, and complete history and physical examination reports. 
13.2 
Retention of Essential Documents 
The study essential documents must be maintained as specified in the ICH guidelines for GCP and 
the applicable regulatory requirements. The Investigator/institution should take measures to 
prevent accidental or premature destruction of these documents. 
Essential documents should be retained until at least 2 years after the last approval of a marketing 
application in an ICH region and until there are no pending or contemplated marketing applications 
in an ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical 
development of the study vaccine. These documents should be retained for a longer period; 
however, if required by the applicable regulatory requirements or by an agreement with the 
Sponsor. It is the responsibility of the Sponsor to inform the Investigator/institution as to when 
these documents no longer need to be retained. 

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14 
ADMINISTRATIVE INFORMATION 
14.1 
Financing and Insurance 
Financing and insurance will be addressed in a separate agreement between the Sponsor and the 
Investigator. 
14.2 
Publication Policy 
The Sponsor will retain ownership of all data. All proposed publications based on this study will 
be subject to Sponsor’s approval requirements. 

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15 
REFERENCES 
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Banik S, Mansour AA, Suresh RV, et al. Development of a multivalent subunit vaccine against 
tularemia using tobacco mosaic virus (TMV) based delivery system. PLoS One. 2015; 10(6): 
e0130858. 
Centers for Disease Control and Prevention. Coronavirus Disease 2019 (COVID-19). 
https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-
conditions.html. Last accessed 09 April 2021. 
de Alwis R, Chen S, Gan ES, et al. Impact of immune enhancement on Covid-19 polyclonal 
hyperimmune globulin therapy and vaccine development. EBioMedicine. 2020 May; 55: 102768. 
Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, 
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2020. 
Du L, Zhao G, He Y, et al. Receptor-binding domain of SARS-CoV spike protein induces long-
term protective immunity in an animal model. Vaccine. 2007 Apr 12;25(15):2832-8. 
Du L, Zhao G, Chan C, et al. Recombinant receptor-binding domain of SARS-CoV spike protein 
expressed in mammalian, insect and E. coli cells elicits potent neutralizing antibody and protective 
immunity. Virology. 2009 Oct 10; 393(1): 144–150. 
Fierz W and Walz B. Antibody Dependent Enhancement Due to Original Antigenic Sin and the 
Development of SARS. Front Immunol. 2020; 11: 1120. 
Guidance for Industry: Drug-Induced Liver Injury: Premarketing Clinical Evaluation (July 2009). 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-induced-liver-
injury-premarketing-clinical-evaluation. Last accessed 15 May 2020. 
Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers 
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information/search-fda-guidance-documents/toxicity-grading-scale-healthy-adult-and-
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Jaume M, Yip MS, Kam YW, et al. SARS CoV subunit vaccine: Antibody mediated neutralisation 
and enhancement. Hong Kong Med J. 2012 Feb;18 Suppl 2:31-6. 
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Kam YW, Kien F, Roberts A, et al. Antibodies against trimeric S glycoprotein protect hamsters 
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in vitro. Vaccine. 2007 Jan 8;25(4):729-40.  
Mallajosyula JK, Jeevan T, Chikwamba R, et al. A single dose TMV-HA vaccine protects mice 
from H5N1 influenza challenge. Int. J. Vaccines Res. 2016 1(2):6. 

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Mallajosyula JK, Hiatt E, Hume S, et al. Single-dose monomeric HA subunit vaccine generates 
full protection from influenza challenge. Hum Vaccin Immunother. 2014;10(3):586-95. 
McCormick AA, Corbo TA, Wykoff-Clary S, et al. Chemical conjugate TMV - Peptide bivalent 
fusion vaccines improve cellular immunity and tumor protection. Bioconjug Chem. Sep-Oct 
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McCormick AA, Corbo TA, Wykoff-Clary S, et al. TMV-peptide fusion vaccines induce cell-
mediated immune responses and tumor protection in two murine models. Vaccine. 2006b Sep 
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https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmi-m.htm. Last accessed 15 May 
2020. 
Quinlan BD, Mou H, Zhang L, et al. The SARS-CoV-2 receptor-binding domain elicits a potent 
neutralizing response without antibody-dependent enhancement. bioRxiv. 2020.04.10.036418. 
Wang N, Shang J, Jiang S, et al. Subunit Vaccines Against Emerging Pathogenic Human 
Coronaviruses. Front Microbiol. 2020; 11: 298. 
World Health Organization. Guidelines on clinical evaluation of vaccines: regulatory expectations 
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at: 
https://www.who.int/biologicals/publications/clinical_guidelines_ecbs_2001.pdf?ua=1. 
Last 
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16 
SIGNATURES 
Protocol Number: KBP-201 
Protocol 
Title: 
A 
Phase 
I/II, 
First-in-human, 
Observer-blinded, 
Randomized, 
Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of 
TAP-COVID-19 SARS-CoV-2 Vaccine with CpG Adjuvant in Healthy Adults Aged 18-49 
and 50-85 
Kentucky BioProcessing, Inc. Signatures 
This clinical study protocol has been reviewed and approved by Kentucky BioProcessing, Inc. 
 
 
 
 
 
 
 
Oscar (Tony) A. Guzman, MD, CP 
Clinical Project Lead 
 
Date 
 
Deleted: Hugh Haydon¶
President

Kentucky BioProcessing, Inc. 
Protocol Number: KBP-201 
Protocol Version 9.0 
 
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Protocol Number: KBP-201 
 
Protocol 
Title: 
A 
Phase 
I/II, 
First-in-human, 
Observer-blinded, 
Randomized, 
Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of 
TAP-COVID-19 SARS-CoV-2 Vaccine with CpG Adjuvant in Healthy Adults Aged 18-49 
and 50-85 
 
Investigator Signature 
I agree to conduct the aforementioned study according to the terms and conditions of the protocol, 
GCP guidelines, and all other applicable local and regulatory requirements. All information 
pertaining to the study will be treated in a confidential manner. 
 
 
 
Site Name 
 
 
 
Print Name 
 
 
 
 
 
Signature 
 
Date 
 

Kentucky BioProcessing, Inc. 
Protocol Number: KBP-201 
Protocol Version 9.0 
 
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APPENDIX A  
DIARY CARD EXAMPLE 
Example Diary Card may be adjusted to add additional subject collection information or CRU 
and/or subject contact information. 
 

Kentucky BioProcessing, Inc. 
Protocol Number: KBP-201 
Protocol Version 9.0 
 
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Kentucky BioProcessing, Inc. 
Protocol Number: KBP-201 
Protocol Version 9.0 
 
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APPENDIX B  
POTENTIAL IMMUNE-MEDIATED MEDICAL CONDITIONS 
Gastrointestinal Disorders 
 Autoimmune pancreatitis 
 Celiac disease 
 Crohn’s disease 
 Microscopic colitis 
 Ulcerative colitis 
 Ulcerative proctitis 
Liver Disorders 
 Autoimmune cholangitis 
 Autoimmune hepatitis 
 Primary biliary cirrhosis 
 Primary sclerosing cholangitis 
Metabolic Diseases 
 Addison’s disease 
 Autoimmune hypophysitis 
 Autoimmune thyroiditis (including Hashimoto thyroiditis) 
 Diabetes mellitus type I  
 Grave’s or Basedow’s disease 
Musculoskeletal Disorders 
 Antisynthetase syndrome 
 Dermatomyositis 
 Juvenile chronic arthritis (including Still’s disease) 
 Mixed connective tissue disorder 
 Polymyalgia rheumatic 
 Polymyositis 
 Psoriatic arthropathy 
 Relapsing polychondritis 
 Rheumatoid arthritis 
 Scleroderma, including diffuse systemic form and CREST (alcinosis, Raynaud’s 
phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia) syndrome 
 Spondyloarthritis, including ankylosing spondylitis, reactive arthritis (Reiter’s 
Syndrome), and undifferentiated spondyloarthritis 
 Systemic lupus erythematosus 
 Systemic sclerosis 
Neuroinflammatory Disorders 
 Acute disseminated encephalomyelitis, including site-specific variants (eg, noninfectious 
encephalitis, encephalomyelitis, myelitis, radiculomyelitis) 

Kentucky BioProcessing, Inc. 
Protocol Number: KBP-201 
Protocol Version 9.0 
 
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 Cranial nerve disorders, including paralyses/paresis (eg, Bell’s palsy) 
 Guillain-Barré syndrome, including Miller Fisher syndrome and other variants  
 Immune-mediated peripheral neuropathies and plexopathies, including chronic 
inflammatory demyelinating polyneuropathy, multifocal motor neuropathy and 
polyneuropathies associated with monoclonal gammopathy 
 Multiple sclerosis 
 Narcolepsy  
 Optic neuritis 
 Transverse myelitis 
 Myasthenia gravis, including Eaton-Lambert syndrome 
Skin Disorders 
 Alopecia areata 
 Autoimmune bullous skin diseases, including pemphigus, pemphigoid and dermatitis 
herpetiformis 
 Cutaneous lupus erythematosus 
 Erythema nodosum 
 Morphoea 
 Lichen planus 
 Psoriasis 
 Sweet’s syndrome 
 Vitiligo 
Vasculitides 
 Large vessels vasculitis including: giant cell arteritis such as Takayasu's arteritis and 
temporal arteritis 
 Medium sized and/or small vessels vasculitis including the following:  
o Polyarteritis nodosa 
o Kawasaki’s disease  
o Microscopic polyangiitis 
o Wegener’ granulomatosis 
o Behcet’s syndrome 
o Leukocytoclastic vasculitis 
o Henoch-Schonlein purpura 
o Necrotizing vasculitis and antineutrophil cytoplasmic antibody (ANCA) positive 
vasculitis (type unspecified) 
o Churg-Strauss syndrome (allergic granulomatous angiitis) 
o Buerger’s disease thromboangiitis obliterans 
Others 
 Antiphospholipid syndrome 
 Autoimmune hemolytic anemia  

Kentucky BioProcessing, Inc. 
Protocol Number: KBP-201 
Protocol Version 9.0 
 
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 Autoimmune glomerulonephritis (including IgA nephropathy, glomerulonephritis rapidly 
progressive, membranous glomerulonephritis, membranoproliferative glomerulonephritis, 
and mesangioproliferative glomerulonephritis) 
 Autoimmune myocarditis/cardiomyopathy 
 Autoimmune neutropenia 
 Autoimmune pancytopenia 
 Autoimmune thrombocytopenia 
 Goodpasture syndrome 
 Idiopathic pulmonary fibrosis 
 Pernicious anemia 
 Polyglandular autoimmune syndrome 
 Raynaud’s phenomenon 
 Sarcoidosis 
 Sjögren’s syndrome 
 Stevens-Johnson syndrome 
 Uveitis 

Kentucky BioProcessing, Inc. 
Protocol Number: KBP-201 
Protocol Version 9.0 
 
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APPENDIX C  
ADDITIONAL ELISA DETAILS 
2) 
 
Name That 
Appears on 
Laboratory Report 
Vendor 
SARs-CoV-2 
Antigen 
Reporting 
Status 
Intended Use 
Anti-SARS-CoV-2 
IgG Qual 
Euroimmun 
Spike (S) 
Blinded 
starting at the 
Day 1 Visit 
It is intended for use as an aid in 
identifying individuals with an adaptive 
immune response to SARS-CoV-2, 
indicating recent or prior infection. At 
this time, it is unknown for how long 
antibodies persist following infection and 
if the presence of antibodies confers 
protective immunity. This test should not 
be used to diagnose acute SARS-CoV-2 
infection. 
SARS-CoV-2  
IgG Qual 
Abbott 
Architect 
Nucleocapsid 
(N) 
Unblinded 
throughout 
the duration 
of the study 
This assay is designed to detect 
immunoglobulin class G (IgG) antibodies 
to the nucleocapsid protein of 
SARS-CoV-2 in serum and plasma from 
individuals who are suspected to have 
had COVID-19 or in serum and plasma 
of subject that may have been infected by 
SARS-CoV-2. 
COVID-19 IgM 
Epitope 
Diagnostics 
Nucleocapsid 
(N) 
Unblinded 
throughout 
the duration 
of the study 
This test is used as an aid for the 
detection of novel COVID-19. 
 

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