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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
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.
China Medical University Hospital
Taichung, Taiwan
GMT of neutralizing antibody against SARS-CoV-2
Evaluation of Immunogenicity
Time frame: Day 1
GMT of neutralizing antibody against SARS-CoV-2
Evaluation of Immunogenicity
Time frame: Day 15
GMT of neutralizing antibody against SARS-CoV-2
Evaluation of Immunogenicity
Time frame: Day 85
Geometric mean fold increase of neutralizing antibody against SARS-CoV-2
Evaluation of Immunogenicity
Time frame: Day 15
Geometric mean fold increase of neutralizing antibody against SARS-CoV-2
Evaluation of Immunogenicity
Time frame: Day 85
Occurrence of adverse reactions and the percentage of subjects with ≥ Grade 3 adverse events
Evaluation of Safety
Time frame: Within 7 days after vaccination
GMT of antigen-specific antibody (Anti-S1-RBD)
Evaluation of Immunogenicity
Time frame: Day 1
GMT of antigen-specific antibody (Anti-S1-RBD)
Evaluation of Immunogenicity
Time frame: Day 15
GMT of antigen-specific antibody (Anti-S1-RBD)
Evaluation of Immunogenicity
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Time frame: Day 85
Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)
Evaluation of Immunogenicity
Time frame: Day 15
Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)
Evaluation of Immunogenicity
Time frame: Day 85
Correlation between the immune response detected by ELISA and live virus neutralization test
Evaluation of Immunogenicity
Time frame: During the study period
Occurrence of SAEs, AESIs, MAAEs and SAEs
Evaluation of Safety
Time frame: During the study period