NCT04673149

GLS-5310 Vaccine for the Prevention of SARS-CoV-2 (COVID-19)

Multicenter, Randomized, Combined Phase I Dose-escalation and Phase IIa Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Immunogenicity of GLS-5310 DNA Vaccine, Administered Intradermally Against SARS-CoV-2 in Healthy Adults

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: GeneOne Life Science, Inc. · Industry
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This clinical trial will evaluate the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2(COVID-19) in healthy volunteers.

Detailed description

This Phase I / IIa study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine. The Phase I portion of this study is an open-label, dose escalation study to assess two dose levels of GLS-5310 DNA vaccine (0.6 and 1.2 mg) as part of two vaccination regimens (0-8 weeks and 0-12 weeks). The Phase IIa portion of this study is designed as a randomized, double-blind, placebo-controlled study with only a single active study drug arm. Subjects will be randomized to receive either placebo or GLS-5310 vaccine in a 1:2 ratio.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	GLS-5310	GLS-5310 DNA plasmid vaccine
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2020-12-31
• Primary completion: 2021-03-03
• Completion: 2023-05-10
• First posted: 2020-12-17
• Last updated: 2025-09-03
• Results posted: 2025-09-03

Locations

1 site across 1 country: South Korea