July. 16, 2021 |
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Dec. 02, 2022 |
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jRCT2051210052 |
A Randomized, Open-label, Uncontrolled, phase I / II study to Assess Safety and Immunogenicity of Two or Three Dosing of Intramuscular / Intradermal AG0302-COVID19 |
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Phase I / II Study of COVID-19 DNA Vaccine (AG0302-COVID19 High-dose) |
Daikyoji Yuichi |
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AnGes, Inc. |
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4-13-3 Shiba, Minato-ku, Tokyo |
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+81-3-5730-2488 |
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anges-cr@anges.co.jp |
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Group PR & IR |
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AnGes, Inc. |
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4-13-3 Shiba, Minato-ku, Tokyo |
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+81-3-5730-2641 |
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info@anges.co.jp |
Complete |
July. 29, 2021 |
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July. 29, 2021 | ||
400 | ||
Interventional |
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randomized controlled trial |
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open(masking not used) |
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uncontrolled control |
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parallel assignment |
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prevention purpose |
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(1) Subjects who have obtained written consent voluntarily to participate in this clinical trial |
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(1) Subjects with symptoms of suspected COVID-19 infection (respiratory symptoms, headache, malaise, olfactory disorders, taste disorders, etc.) |
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18age old over | ||
No limit | ||
Both |
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COVID-19 |
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Vaccination 1 to 8 mg of AG0302-COVID19 three times at 2-week intervals or twice at 4-week intervals |
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SARS-CoV-2 |
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1. Incidence of Treatment-Emergent Adverse Events |
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1. Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody |
AnGes, Inc. |
Japan Agency for Medical Reseaech and Development | |
Not applicable |
Medical Corporation Heishinkai OPHAC Hospital IRB | |
4-1-9, Miyahara,Yodogawa-ku,Osaka, Osaka | |
+81-6-6395-9000 |
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sumiko.kawamoto@heishinkai.com | |
Approval | |
No |
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none |