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

August 13, 2025 updated by: GeneOne Life Science, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
171

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea, 08308
        • Korea University Guro Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Current or planned pregnancy through to 4 weeks post-boost vaccination for women of childbearing potential
  2. Currently breastfeeding
  3. Current or past participation in a coronavirus (MERS-CoV, SARS-CoV-2) vaccine study
  4. Administration of an investigational agent within 6 months of the 1st dose
  5. Administration of a vaccine within 4 weeks prior to the 1st dose
  6. Administration of immune globulin within 16 weeks of enrollment
  7. Administration of an anti-TNFα inhibitor such as infliximab, adalimumab, etanercept, or anti-CD20 monoclonal antibody rituximab within 24 weeks prior to enrollment
  8. 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
  9. Administration of any Immunosuppressive Drug or Immunomodulator within 3 months of the first dose
  10. History of bone marrow transplantation
  11. Current or planned chemotherapy treatment for hematologic or solid tumor during study period or treatment during the 5 years prior to enrollment
  12. Respiratory disease (ex. Asthma, Chronic obstructive lung disease)
  13. Cardiovascular disease (ex. myocardial ischemia, congestive heart failure, cardiomyopathy, clinically significant arrhythmia)
  14. Hypertension (Systolic pressure >150mmHg or Diastolic pressure >95mmHg)
  15. Confirmed Diabetes
  16. Severe allergic reaction or anaphylactic reaction after vaccination in the past
  17. Immunosuppresion including immunodeficiency disease or family history
  18. Positive of serum test at screening (Hepatitis B, Hepatitis A, HIV, Hepatitis C)
  19. Baseline screening lab(s) with Non Clinical Significant abnormality
  20. Serious adverse reaction to a drug containing Investigational Product (GLS-5310) or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history
  21. History of hypersensitivity to vaccination such as Guillain-Barre syndrome
  22. History of PCR-confirmed infection with SARS-CoV-2 at screening
  23. Subjects who have been contact with COVID-19 infections in the past prior to administration, have been classified as COVID-19 confirmed patients, medical patients or patients with symptoms or have been identified with SARS and MERS infection history in the past
  24. 37.5 degrees, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration
  25. Healthcare workers participating in the medical examination of patients infected with COVID-19
  26. Not willing to allow storage and future use of samples for SARS-CoV-2 related research
  27. Prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness
  28. Any illness or condition that, in the opinion of the investigator, may affect the safety of the subject or the evaluation of a study endpoint

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GLS-5310 0.6mg [Group 1a]
0.6mg of GLS-5310 will be intradermally administered on Day 0 and Week 8.
Biological: GLS-5310
GLS-5310 DNA plasmid vaccine
Experimental: GLS-5310 1.2mg [Group 1b]
1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8.
Biological: GLS-5310
GLS-5310 DNA plasmid vaccine
Experimental: GLS-5310 1.2mg [Group 1c]
1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 12.
Biological: GLS-5310
GLS-5310 DNA plasmid vaccine
Placebo Comparator: Placebo [Group 2a]
Placebo will be intradermally administered on Day 0 and Week 8 (or Week 12).
Biological: Placebo
Placebo
Experimental: GLS-5310 1.2mg [Group 2b]
1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8 (or Week 12).
Biological: GLS-5310
GLS-5310 DNA plasmid vaccine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Serious Adverse Events
Time Frame: Through 48 weeks post vaccination
Through 48 weeks post vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants With Positive T Cell Responses Induced by GLS-5310
Time Frame: Post vaccination Visit 4 (4 weeks after week 8 or week 12 vaccination)
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
Time Frame: Post vaccination Visit 4 (4 weeks after week 8 or week 12 vaccination)
Post vaccination Visit 4 (4 weeks after week 8 or week 12 vaccination)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determine IgG antibody responses after a single dose of vaccine related to treatment arm
Time Frame: Through 1 year post vaccination
Endpoint titer of binding antibody in serum at each timepoint
Through 1 year post vaccination
Measure survival rate of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2.
Time Frame: Through 1 year post vaccination
Survival rate
Through 1 year post vaccination
Persistence of immune responses following vaccination with GLS-5310
Time Frame: Through 1 year post vaccination

Endpoint titer of binding antibody in serum at each timepoint

  • Plaque-reduction neutralizing titer in serum at each timepoint
  • T-cell response of antigen-specific interferon - gamma (IFN-γ) secretion in PBMC at each timepoint
Through 1 year post vaccination
Determine the extent of immune boosting for participants who are seropositive at baseline following vaccination with GLS-5310
Time Frame: Through 1 year post vaccination

Change from baseline in binding antibody titers

  • Change from baseline in T-cell response of antigen-specific interferon - gamma (IFN-γ)
  • Change from baseline in plaque-reduction neutralizing titer(PRNT) in serum
Through 1 year post vaccination
Measure viral load in organs, including blood, of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2.
Time Frame: Through 1 year post vaccination
viral load measurement of blood and major organs
Through 1 year post vaccination
Perform histologic examination of organs of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2.
Time Frame: Through 1 year post vaccination
pathological examination of organs
Through 1 year post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GeneOne Life Science, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CoV2-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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