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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
| |
| Group C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG0302-COVID19 | Biological | 2.0 mg of AG0302-COVID19 twice at 2-week intervals |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 1 through Week 9 |
| Immunogenicity | Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody | Weeks 3, 5, 7, 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody | Weeks 13, 25, 53 | |
| Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody | Weeks 3, 5, 7, 9, 13, 25, 53 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AnGes, Inc. Clinical Development | AnGes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka University Hospital | Osaka | Japan |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| AG0302-COVID19 |
| Biological |
2.0 mg of AG0302-COVID19 twice at 4-week intervals |
|
| AG0302-COVID19 | Biological | 2.0 mg of AG0302-COVID19 three times at 2-week intervals |
|
| Change in GMT of anti-SARS-CoV-2 B cell epitope antibody | Week 9 |
| Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody | Weeks 3, 5, 7, 9, 13, 25, 53 |
| Change in the neutralizing activity against pseudovirus of SARS-CoV-2 | Weeks 3, 5, 7, 9, 13, 25, 53 |
| Change in binding inhibition of SARS-CoV-2 spike (S) glycoprotein and ACE2 | 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 | Weeks 3, 5, 7, 9, 13, 25, 53 |
| Adverse events | Week 9 through Week 53 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |