NCT04993586

Phase I/II Study of COVID-19 DNA Vaccine (AG0302-COVID19 High-dose)

A Randomized, Open-label, Uncontrolled, Phase I/II Study to Assess Safety and Immunogenicity of Two or Three Dosing of Intramuscular/Intradermal AG0302-COVID19

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 422 (actual)
• Sponsor: AnGes, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This is a Phase I/II, multi-center, randomized, open-label, uncontrolled trial. Approximately 400 healthy volunteers, male or female, aged 18 years or older, will be randomized to one of the following five groups: \[IM Groups\] Group A: Vaccination 2 mg, three times at 2-week intervals (n = 80) Group B: Vaccination 4 mg, twice at 4-week intervals (n = 80) Group C: Vaccination 8 mg, twice at 4-week intervals(n = 80) \[ID Groups\] Group D: Vaccination 1 mg, three times at 2-week intervals (n = 80) Group E: Vaccination 1 mg, twice at 4-week intervals (n = 80)

Conditions

• COVID-19 Lower Respiratory Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-07-29
• Primary completion: 2021-12-10
• Completion: 2022-09-23
• First posted: 2021-08-06
• Last updated: 2022-11-09

Locations

6 sites across 1 country: Japan