A Phase I, Open-Label Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 Vaccine in Healthy Adult Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- United Biomedical Inc., Asia
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- GMT of neutralizing antibody against SARS-CoV-2
- Status
- Completed
- Last Updated
- 3 years ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
GMT of neutralizing antibody against SARS-CoV-2
Time Frame: Day 85
Evaluation of Immunogenicity
Geometric mean fold increase of neutralizing antibody against SARS-CoV-2
Time Frame: Day 85
Evaluation of Immunogenicity
Occurrence of adverse reactions and the percentage of subjects with ≥ Grade 3 adverse events
Time Frame: Within 7 days after vaccination
Evaluation of Safety
Secondary Outcomes
- Correlation between the immune response detected by ELISA and live virus neutralization test(During the study period)
- Occurrence of SAEs, AESIs, MAAEs and SAEs(During the study period)
- GMT of antigen-specific antibody (Anti-S1-RBD)(Day 85)
- Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)(Day 85)