This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.
This is a Phase 1/2, single-center, non-randomised, open-label, non-controlled trial. Approximately 30 healthy volunteers, male or female, aged 20-65, will be enrolled in the low dose group for the first 15 and the high dose group for the remaining 15. Low dose group: 1.0 mg AG0301-COVID19 intramuscular (IM) (n = 15) High dose group: 2.0 mg AG0301-COVID19 IM (n = 15)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
1.0 mg of AG0301-COVID19 twice at 2-week intervals
2.0 mg of AG0301-COVID19 twice at 2-week intervals
Osaka City University Hospital
Osaka, Japan
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after first vaccination
Time frame: Week 1 through Week 9
Immunogenicity
Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Time frame: Weeks 3, 5, 7, 9
Change in GMT of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Time frame: Weeks 13, 25, 53
Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody
Time frame: Weeks 3, 5, 7, 9, 13, 25, 53
Change in GMT of anti-SARS-CoV-2 B cell epitope antibody
Time frame: Weeks 3, 5, 7, 9, 13, 25, 53
Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Time frame: Weeks 3, 5, 7, 9, 13, 25, 53
Adverse events
Time frame: Week 9 through Week 53
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