This is a phase I, open-label, dose-escalation clinical study to evaluate the safety, tolerability and immunogenicity of 3 ascending doses of UB-612 COVID-19 vaccine in healthy adults, aged from 20 to 55 years old.
This is a phase I, open-label, dose-escalation clinical study to evaluate the safety, tolerability and immunogenicity of 3 ascending doses of UB-612 COVID-19 vaccine in healthy adults. Up to 60 subjects (20 subjects per group) will be enrolled into this study. Subjects in each group will be enrolled to receive two doses of UB-612 vaccine at 28-day interval (Day 0 and Day 28).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
UB-612 is a proprietary high-precision designer S1-RBD-protein based vaccine incorporating a Th/CTL epitope peptide pool which could bind to human MHC-I and MHC-II to activate T cells.
China Medical University Hospital
Taichung, Taiwan
Safety of UB-612 vaccine
1. Occurrence of adverse reactions within 7 days after vaccination 2. Percentage of subjects with ≥ Grade 3 adverse events within 7 days after vaccination
Time frame: 7 days following vaccination
Safety
1. Occurrence of adverse events (AEs) till Day 56 2. Occurrence of serious adverse events (SAEs) till Day 56
Time frame: Day 0 to Day 56
Safety
Occurrence of serious adverse events during the whole follow-up period
Time frame: Day 29 to Day 196
Safety
Occurrence of adverse events of special interest during the study period
Time frame: Day 0 to Day 196
Immunogenicity
Geometric mean titer (GMT) of antigen-specific antibody (Anti-S1-RBD)
Time frame: Day 14, 28, 42, 56, 112, and 196
Immunogenicity
Seroconversion rate (SCR) of antigen-specific antibody (Anti-S1-RBD)
Time frame: Day 14, 28, 42, 56, 112, and 196
Immunogenicity
Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)
Time frame: Day 14, 28, 42, 56, 112, and 196
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