A Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine

Study Overview
=================
Brief Summary
-----------------
This is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612 vaccine 10, 30, and 100 μg in V-122 study.

Detailed Description
-----------------
This is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612 vaccine 10, 30, and 100 μg in V-122 study. 60 subjects will receive one booster dose of UB-612 vaccines 100 μg with the same dose which was offered in Phase II study, at least 6 months after first vaccination. In this study, there will be 3 clinical visits. Subjects will come to the clinics at Day 1, Day 15, and Day 85.

Official Title
-----------------
A Phase I, Open-Label Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 Vaccine in Healthy Adult Volunteers

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Biological: UB-612


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Male or non-pregnant female who previously participated in and completed two vaccinations in the V-122 Study. Women of childbearing potential and men must agree to practice medically effective contraception during study period. Able to understand the content and possible risks of informed consent and willing to sign the Informed Consent Form (ICF). Able to understand and agrees to comply with all study procedures and be available for all study visits. Ear temperature ≤ 38.0°C. At screening visit, at least 6 months after first vaccination in the V-122 study. Exclusion Criteria Female who is pregnant or positive in pregnancy test at screening visit. Female who is breast-feeding or plans to breastfeed within 90 days after booster vaccination. Any acute illness, as determined by the study investigator 3 days before booster vaccination. Prior administration of attenuated, nucleic acid (mRNA or DNA) or vectored vaccines in last 1 month before booster vaccination or expectation of such vaccines in the month after booster vaccination. Prior administration of subunit vaccine or inactivated vaccine in last 14 days before booster vaccination or expectation of receipt of such vaccines in the 14 days after booster vaccination. Any medical disease or condition that, in the opinion of the study investigator, may confound the results of the study or pose an additional risk to the subjects by their participation in the study. Previous exposure to SARS-CoV-2 or receipt of an investigational or EUA vaccine product for the prevention of COVID-19, MERS or SARS except UB-612. Subjects who take part in another clinical study, other than V-122 study, within 12 weeks prior to the day of informed consent. Prior administration of immunoglobulins and/or any blood products in last 4 months before booster vaccination. Prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before first vaccination.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A group: 1 booster dose of UB-612 vaccine 100 μg<br>1 booster dose for subjects at UB-612 vaccine 10 μg in V-122 study. | Biological: UB-612<br>* UB-612 includes a designer S1-RBD-sFc fusion protein formulated with designer Th and CTL epitope peptides selected from immunodominant M, S2 and N regions known to bind to human MHC I and II.<br>|
| Experimental: B group: 1 booster dose of UB-612 vaccine 100 μg<br>1 booster dose for subjects at UB-612 vaccine 30 μg in V-122 study. | Biological: UB-612<br>* UB-612 includes a designer S1-RBD-sFc fusion protein formulated with designer Th and CTL epitope peptides selected from immunodominant M, S2 and N regions known to bind to human MHC I and II.<br>|
| Experimental: C group: 1 booster dose of UB-612 vaccine 100 μg<br>1 booster dose for subjects at UB-612 vaccine 100 μg in V-122 study. | Biological: UB-612<br>* UB-612 includes a designer S1-RBD-sFc fusion protein formulated with designer Th and CTL epitope peptides selected from immunodominant M, S2 and N regions known to bind to human MHC I and II.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMT of neutralizing antibody against SARS-CoV-2 | Evaluation of Immunogenicity | Day 1 | 
| GMT of neutralizing antibody against SARS-CoV-2 | Evaluation of Immunogenicity | Day 15 | 
| GMT of neutralizing antibody against SARS-CoV-2 | Evaluation of Immunogenicity | Day 85 | 
| Geometric mean fold increase of neutralizing antibody against SARS-CoV-2 | Evaluation of Immunogenicity | Day 15 | 
| Geometric mean fold increase of neutralizing antibody against SARS-CoV-2 | Evaluation of Immunogenicity | Day 85 | 
| Occurrence of adverse reactions and the percentage of subjects with ≥ Grade 3 adverse events | Evaluation of Safety | Within 7 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMT of antigen-specific antibody (Anti-S1-RBD) | Evaluation of Immunogenicity | Day 1 | 
| GMT of antigen-specific antibody (Anti-S1-RBD) | Evaluation of Immunogenicity | Day 15 | 
| GMT of antigen-specific antibody (Anti-S1-RBD) | Evaluation of Immunogenicity | Day 85 | 
| Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD) | Evaluation of Immunogenicity | Day 15 | 
| Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD) | Evaluation of Immunogenicity | Day 85 | 
| Correlation between the immune response detected by ELISA and live virus neutralization test | Evaluation of Immunogenicity | During the study period | 
| Occurrence of SAEs, AESIs, MAAEs and SAEs | Evaluation of Safety | During the study period |