NCT04715997

Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults

A Phase 1/2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: Genexine, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of our study is to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive DNA vaccine in healthy volunteers.

Detailed description

This clinical study is phase 1/2a clinical trial to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive vaccine by intramuscularly administration in healthy volunteers. Phase 1 of this study is designed as single arm, open-labeled and a total of 20 subjects will be enrolled. Phase 2a of study is designed as randomized, double-blind, placebo controlled and a total of 150 subjects are planned to be enrolled.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
DRUG	GX-19N	DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen
DRUG	Placebo	Normal saline

Timeline

• Start date: 2020-12-30
• Primary completion: 2022-04-19
• Completion: 2022-04-19
• First posted: 2021-01-20
• Last updated: 2025-08-20

Locations

5 sites across 1 country: South Korea