NCT04527081

Study of COVID-19 DNA Vaccine (AG0302-COVID19)

A Randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Twice or Three Times Dosing of Intramuscular AG0302-COVID19 (2mg) in Healthy Adults

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AnGes, Inc. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy adult volunteers.

Detailed description

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)

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	AG0302-COVID19	2.0 mg of AG0302-COVID19 twice at 2-week intervals
BIOLOGICAL	AG0302-COVID19	2.0 mg of AG0302-COVID19 twice at 4-week intervals
BIOLOGICAL	AG0302-COVID19	2.0 mg of AG0302-COVID19 three times at 2-week intervals

Timeline

• Start date: 2020-08-31
• Primary completion: 2020-11-09
• Completion: 2021-09-24
• First posted: 2020-08-26
• Last updated: 2021-10-04

Locations

1 site across 1 country: Japan