NCT04655625

Phase II / III Study of COVID-19 DNA Vaccine (AG0302-COVID19)

A Randomized, Double-blind, Placebo Controlled Phase II / III Study to Assess Safety, Immunogenicity and Efficacy of Twice Dosing of Intramuscular AG0302-COVID19 (2mg) in Healthy Adults

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: AnGes, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This is a Phase II /III, multi-center, randomized, double-blind, placebo controlled trial. Approximately 500 healthy volunteers, male or female, aged 18 years or older, will be randomized to one of the following two groups: Group A: Vaccination twice at 2-week intervals (n = 250) Group B: Vaccination twice at 4-week intervals (n = 250) Fifty subjects in each group will receive placebos.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Group A (AG0302-COVID19)	2 mg of AG0302-COVID19 twice at 2-week intervals
BIOLOGICAL	Group A (Placebo)	Placebo twice at 2-week intervals
BIOLOGICAL	Group B (AG0302-COVID19)	2 mg of AG0302-COVID19 twice at 4-week intervals
BIOLOGICAL	Group B (Placebo)	Placebo twice at 4-week intervals

Timeline

• Start date: 2020-11-23
• Primary completion: 2021-04-02
• Completion: 2022-02-01
• First posted: 2020-12-07
• Last updated: 2022-06-08

Locations

8 sites across 1 country: Japan