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

NCT04673149 | Completed Phase 1 Results DMC

• 1 other identifier: CoV2-001
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS-CoV-2

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of Serious Adverse Events

  Through 48 weeks post vaccination

Secondary Outcomes (2)

• Number of Participants With Positive T Cell Responses Induced by GLS-5310

  Post vaccination Visit 4 (4 weeks after week 8 or week 12 vaccination)

• Number of Participants With Positive Neutralizing Antibody Responses Induced by GLS-5310

  Post vaccination Visit 4 (4 weeks after week 8 or week 12 vaccination)

Study Arms (5)

GLS-5310 0.6mg [Group 1a]

EXPERIMENTAL

0.6mg of GLS-5310 will be intradermally administered on Day 0 and Week 8.

Biological: GLS-5310

GLS-5310 1.2mg [Group 1b]

EXPERIMENTAL

1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8.

Biological: GLS-5310

GLS-5310 1.2mg [Group 1c]

EXPERIMENTAL

1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 12.

Biological: GLS-5310

Placebo [Group 2a]

PLACEBO COMPARATOR

Placebo will be intradermally administered on Day 0 and Week 8 (or Week 12).

Biological: Placebo

GLS-5310 1.2mg [Group 2b]

EXPERIMENTAL

1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8 (or Week 12).

Biological: GLS-5310

Interventions

GLS-5310 BIOLOGICAL

GLS-5310 DNA plasmid vaccine

GLS-5310 0.6mg [Group 1a]; GLS-5310 1.2mg [Group 1b]; GLS-5310 1.2mg [Group 1c]; GLS-5310 1.2mg [Group 2b]

Placebo BIOLOGICAL

Placebo

Placebo [Group 2a]

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19 to 85 years of age (Phase I will be restricted to an upper age limit of 50 years of age)
• Able to provide informed consent
• Able and willing to comply with study procedures
• For women of childbearing potential, able and willing to use an approved form of pregnancy prevention through to 4 weeks post boost vaccination

You may not qualify if:

• Current or planned pregnancy through to 4 weeks post-boost vaccination for women of childbearing potential
• Currently breastfeeding
• Current or past participation in a coronavirus (MERS-CoV, SARS-CoV-2) vaccine study
• Administration of an investigational agent within 6 months of the 1st dose
• Administration of a vaccine within 4 weeks prior to the 1st dose
• Administration of immune globulin within 16 weeks of enrollment
• Administration of an anti-TNFα inhibitor such as infliximab, adalimumab, etanercept, or anti-CD20 monoclonal antibody rituximab within 24 weeks prior to enrollment
• Current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater, dexamethasone of 3 mg or greater; or the equivalent dose of other systemic corticosteroids
• Administration of any Immunosuppressive Drug or Immunomodulator within 3 months of the first dose
• History of bone marrow transplantation
• Current or planned chemotherapy treatment for hematologic or solid tumor during study period or treatment during the 5 years prior to enrollment
• Respiratory disease (ex. Asthma, Chronic obstructive lung disease)
• Cardiovascular disease (ex. myocardial ischemia, congestive heart failure, cardiomyopathy, clinically significant arrhythmia)
• Hypertension (Systolic pressure \>150mmHg or Diastolic pressure \>95mmHg)
• Confirmed Diabetes

Sponsors & Collaborators

• GeneOne Life Science, Inc.: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

MeSH Terms

Conditions

COVID-19

Interventions

GLS-5310 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: GeneOne Life Science

dkane@genels.us

6106576351

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: December 31, 2020
• Primary Completion: March 3, 2021
• Study Completion: May 10, 2023
• Last Updated: September 3, 2025
• Results First Posted: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)