This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy adult volunteers.
This is a Phase 1/2, single-center, randomized, open-label, non-controlled trial. Approximately 30 healthy volunteers, male or female, aged 20-65, will be randomized to one of the following three groups. Group A: Vaccination twice at 2-week intervals (n = 10) Group B: Vaccination twice at 4-week intervals (n = 10) Group C: Vaccination 3 times at 2-week intervals (n = 10)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
2.0 mg of AG0302-COVID19 twice at 2-week intervals
2.0 mg of AG0302-COVID19 twice at 4-week intervals
2.0 mg of AG0302-COVID19 three times at 2-week intervals
Osaka 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: Week 9
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
Change in the neutralizing activity against pseudovirus of SARS-CoV-2
Time frame: Weeks 3, 5, 7, 9, 13, 25, 53
Change in binding inhibition of SARS-CoV-2 spike (S) glycoprotein and ACE2
Time frame: Weeks 3, 5, 7, 9, 13, 25, 53
Change in IFN-γ production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells
Time frame: Weeks 3, 5, 7, 9, 13, 25, 53
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Adverse events
Time frame: Week 9 through Week 53