This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult
volunteers.
Primary Outcomes
Description: Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after each vaccination
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Time: Week 1 through Week 9
Description: Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike glycoprotein-specific antibody
Measure: Immunogenicity
Time: Weeks 3, 5, 7, 9
Secondary Outcomes
Measure: Change in GMT of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody Time: Weeks 13, 25, 53
Measure: Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody Time: Weeks 3, 5, 7, 9, 13, 25, 53
Measure: Change in GMT of anti-SARS-CoV-2 B cell epitope antibody Time: Weeks 3, 5, 7, 9, 13, 25, 53
Measure: Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody Time: Weeks 3, 5, 7, 9, 13, 25, 53
Measure: Adverse events Time: Week 9 through Week 53
This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult
volunteers.
Primary Outcomes
Description: Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after each vaccination
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Time: Week 1 through Week 9
Description: Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike glycoprotein-specific antibody
Measure: Immunogenicity
Time: Weeks 3, 5, 7, 9
Secondary Outcomes
Measure: Change in GMT of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody Time: Weeks 13, 25, 53
Measure: Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody Time: Weeks 3, 5, 7, 9, 13, 25, 53
Measure: Change in GMT of anti-SARS-CoV-2 B cell epitope antibody Time: Weeks 3, 5, 7, 9, 13, 25, 53
Measure: Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody Time: Weeks 3, 5, 7, 9, 13, 25, 53
Measure: Adverse events Time: Week 9 through Week 53