NCT05085639

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

Phase I Study of the Safety, Tolerability and Immunogenicity of GLS-5310 DNA Vaccine Against SARS-CoV-2

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: GeneOne Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Phase I study of the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2 (COVID-19)

Detailed description

This Phase I, randomized, placebo-controlled, dose-ranging, single-blind study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine administered intradermally (ID) with or without concomitant intranasal (IN) administration of GLS-5310. Vaccine delivered ID will either be performed by Mantoux injection and followed by suction applied to the skin surface using the Gene-Derm device or Mantous injection alone without applied suction. Vaccine delivered IN will be administered using the MAD300 atomizer.

Conditions

• Covid19
• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	GLS-5130	GLS-5310 DNA plasmid vaccine
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-04-01
• Completion: 2022-12-01
• First posted: 2021-10-20
• Last updated: 2021-10-20

Locations

2 sites across 1 country: Puerto Rico

Regulatory

• FDA-regulated drug study