This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy volunteers.
This is a Phase I/II, multi-center, randomized, open-label, uncontrolled trial. Approximately 400 healthy volunteers, male or female, aged 18 years or older, will be randomized to one of the following five groups: \[IM Groups\] Group A: Vaccination 2 mg, three times at 2-week intervals (n = 80) Group B: Vaccination 4 mg, twice at 4-week intervals (n = 80) Group C: Vaccination 8 mg, twice at 4-week intervals(n = 80) \[ID Groups\] Group D: Vaccination 1 mg, three times at 2-week intervals (n = 80) Group E: Vaccination 1 mg, twice at 4-week intervals (n = 80)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
422
Vaccination 2 mg of AG0302-COVID19 three times at 2-week intervals
Vaccination 4 mg of AG0302-COVID19 twice at 4-week intervals
Vaccination 8 mg of AG0302-COVID19 twice at 4-week intervals
IUHW Narita Hospital
Narita, Chiba, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita, Osaka, Japan
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, Japan
Medical Corporation Shinanokai Shinanozaka 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 12 weeks after first vaccination
Time frame: Week 1 through Week 13
Immunogenicity
Change in the neutralizing activity against pseudovirus of SARS-CoV-2 \[ID50\]
Time frame: Week 13
Immunogenicity
Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
Time frame: Week 13
Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
Time frame: Weeks 5, 7, 9, 13, 17, 21, 25, 37, 53
Change in the neutralizing activity against pseudovirus of SARS-CoV-2
Time frame: Weeks 5, 7, 9, 13, 17, 21, 25, 37, 53
Seroconversion rate from baseline (defined as a 4-fold or greater increase) in the neutralizing activity against pseudovirus of SARS-CoV-2 [ID50]
Time frame: Weeks 5, 7, 9, 13, 17, 21, 25, 37, 53
Change in IFN-gamma production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells
Time frame: Weeks 5, 7, 9, 13
IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Time frame: Weeks 1, 9, 13
Adverse events
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Vaccination 1 mg of AG0302-COVID19 three times at 2-week intervals
Vaccination 1 mg of AG0302-COVID19 twice at 4-week intervals
Sekino Clinical Pharmacology Clinic
Toshima-ku, Tokyo, Japan
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Japan
Time frame: Week 13 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
Rate of swelling and leakage of the drug to the vaccination site during intradermal vaccination
Time frame: Weeks 1, 3, 5
Number of defects in preparation and vaccination during intradermal vaccination
Time frame: Week 1 through Week 5