Phase I/II Study of COVID-19 DNA Vaccine (AG0302-COVID19 High-dose)
NCT04993586 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 422
Last updated 2022-11-09
Summary
This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy volunteers.
Conditions
- COVID-19 Lower Respiratory Infection
Interventions
- BIOLOGICAL
-
AG0302-COVID19 for Intramuscular Injection
Vaccination 2 mg of AG0302-COVID19 three times at 2-week intervals
- BIOLOGICAL
-
AG0302-COVID19 for Intramuscular Injection
Vaccination 4 mg of AG0302-COVID19 twice at 4-week intervals
- BIOLOGICAL
-
AG0302-COVID19 for Intramuscular Injection
Vaccination 8 mg of AG0302-COVID19 twice at 4-week intervals
- BIOLOGICAL
-
AG0302-COVID19 for Intradermal Injection
Vaccination 1 mg of AG0302-COVID19 three times at 2-week intervals
- BIOLOGICAL
-
AG0302-COVID19 for Intradermal Injection
Vaccination 1 mg of AG0302-COVID19 twice at 4-week intervals
Sponsors & Collaborators
-
Japan Agency for Medical Research and Development
collaborator OTHER_GOV -
AnGes, Inc.
lead INDUSTRY
Principal Investigators
-
Clinical Development · AnGes, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-07-29
- Primary Completion
- 2021-12-10
- Completion
- 2022-09-23
Countries
- Japan
Study Locations
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