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

Phase 1

• Conditions: Healthy; Covid19
• Interventions: Biological: GLS-5130; Biological: Placebo

• Registration Number: NCT05085639
• Lead Sponsor: GeneOne Life Science, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2020-12-23
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-18
• Last Update Submitted: 2021-10-18
• Study First Posted: 2021-10-20
• Last Update Posted: 2021-10-20
• Study Start: 2021-11
• Primary Completion: 2022-04
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GLS-5310 1.2 mg (Group 1)	GLS-5130	GLS-5310 1.2 mg (ID + Gene-Derm) at Day 0 and Week 8
GLS-5310 2.4 mg (Group 2)	GLS-5130	GLS-5310 1.2 mg (ID + Gene-Derm) + 1.2 mg (IN) at Day 0 and Week 8
GLS-5310 1.2 mg (Group 3)	GLS-5130	GLS-5310 1.2 mg ID at Day 0 and Week 8
Placebo (Group 4)	Placebo	Placebo (ID + Gene-Derm) at Day 0 and Week 8

Primary Outcome Measures

Name	Time	Method
Geometric mean titer (GMT) of antigen specific antibody titers	Through 56 weeks post vaccination	Endpoint titer of binding antibody in serum
Incidence of adverse events	Through 56 weeks post vaccination	solicited/unsolicited local and systemic AEs

Secondary Outcome Measures

Name	Time	Method
Evaluation of positive response rate of T cell responses induced by GLS-5310	Through 56 weeks post vaccination	T-cell response of antigen-specific interferon - gamma (IFN-γ) secretion in PBMC at each timepoint
Geometric mean titer (GMT) of neutralizing antibody titers	Through 56 weeks post vaccination	Plaque-reduction neutralizing titer(PRNT) in serum at each timepoint

Trial Locations

Locations (2)

University of Puerto Rico; 🇵🇷 San Juan, Puerto Rico

Clinical Research Puerto Rico; 🇵🇷 San Juan, Puerto Rico