NCT05182567

GLS-5310 Vaccine in Healthy Volunteers as a Booster for SARS-CoV-2 (COVID-19)

Safety, Tolerability and Immunogenicity of GLS-5310 DNA Vaccine Given as a Booster to Those Previously Vaccinated Against SARS-CoV-2

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: GeneOne Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Phase I study to assess the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine given as a booster to those previously vaccinated against SARS-CoV-2

Detailed description

This Phase I, randomized, placebo-controlled study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine administered intradermally (ID) with or without concomitant intranasal (IN) administration given as a heterologous booster dose to those previously vaccinated against SARS-CoV-2.

Conditions

• COVID-19
• Healthy

Interventions

Type	Name	Description
DRUG	GLS-5310 (Group 1)	GLS-5310 DNA plasmid vaccine
DRUG	GLS-5310 (Group 2)	GLS-5310 DNA plasmid vaccine
DRUG	GLS-5310 (Group 3)	GLS-5310 DNA plasmid vaccine
DRUG	GLS-5310 (Group 4)	GLS-5310 DNA plasmid vaccine

Timeline

• Start date: 2022-05-23
• Primary completion: 2023-01-10
• Completion: 2023-12-01
• First posted: 2022-01-10
• Last updated: 2023-09-13

Locations

3 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study