This study will assess the safety, immunogenicity and efficacy of AG0302-COVID19 in healthy adult volunteers.
This is a Phase II /III, multi-center, randomized, double-blind, placebo controlled trial. Approximately 500 healthy volunteers, male or female, aged 18 years or older, will be randomized to one of the following two groups: Group A: Vaccination twice at 2-week intervals (n = 250) Group B: Vaccination twice at 4-week intervals (n = 250) Fifty subjects in each group will receive placebos.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
500
2 mg of AG0302-COVID19 twice at 2-week intervals
Placebo twice at 2-week intervals
2 mg of AG0302-COVID19 twice at 4-week intervals
UHW Narita Hospital
Narita, Chiba, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita, Osaka, Japan
Medical Corporation Tsurukamekai Shinjuku Tsurukame C linic
Shibuya-ku, Tokyo, Japan
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, Japan
Incidence of Treatment-Emergent Adverse Events
Frequency and severity of each adverse event solicited local and systemic AEs from the first vaccination to 4 weeks after the second vaccination
Time frame: Group A: 6 weeks Group B: 8 weeks
Immunogenicity
Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
Time frame: Group A: Week 7 Group B: Week 9
Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
Time frame: Group A: Weeks 5, 25, 53 Group B: Weeks 7, 25, 53
Change in the neutralizing activity against pseudovirus of SARS-CoV-2
Time frame: Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53
Change in IFN-gamma production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells
Time frame: Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53
IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Time frame: Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53
Adverse events
Time frame: Group A: Week 7 through Week 53 Group B: Week 9 through Week 53
Rate of SARS-CoV-2 positive and incidence rate of COVID-19 after the first vaccination
Time frame: Week 1 through Week 53
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Placebo twice at 4-week intervals
Medical Corporation Shinanokai Shinanozaka Clinic
Shinjuku-ku, Tokyo, Japan
Sekino Clinical Pharmacology Clinic
Toshima-ku, Tokyo, Japan
NISHI-UMEDA Clinic for Asian Medical Collaboration
Osaka, Japan
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Japan