SARS-CoV-2Phase 1/2NCT04673149
GLS-5310 Vaccine for the Prevention of SARS-CoV-2 (COVID-19)
A Phase 1/2 study testing GLS-5310 in people with SARS-CoV-2, run by GeneOne Life Science, Inc. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- GLS-5310
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Dec 2020to 10 May 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
- Severe allergic reaction or anaphylactic reaction after vaccination in the past
- Immunosuppresion including immunodeficiency disease or family history
- Positive of serum test at screening (Hepatitis B, Hepatitis A, HIV, Hepatitis C)
- Baseline screening lab(s) with Non Clinical Significant abnormality
- 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
- History of hypersensitivity to vaccination such as Guillain-Barre syndrome
- History of PCR-confirmed infection with SARS-CoV-2 at screening
- 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
- 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
- Healthcare workers participating in the medical examination of patients infected with COVID-19
- Not willing to allow storage and future use of samples for SARS-CoV-2 related research
- Prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- SARS-CoV-2
- Being tested
- GLS-5310, Placebo
- Keywords
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLS-5310Biological
GLS-5310 DNA plasmid vaccine
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| GLS-5310 0.6mg [Group 1a] | Experimental | 0.6mg of GLS-5310 will be intradermally administered on Day 0 and Week 8. Receives: 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. Receives: 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. Receives: Biological: GLS-5310 |
| Placebo [Group 2a] | Placebo comparator | Placebo will be intradermally administered on Day 0 and Week 8 (or Week 12). Receives: 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). Receives: Biological: GLS-5310 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Serious Adverse Events
Measured: Through 48 weeks post vaccination
Secondary outcomes (2)
Number of Participants With Positive T Cell Responses Induced by GLS-5310
Measured: 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
Measured: Post vaccination Visit 4 (4 weeks after week 8 or week 12 vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start31 Dec 2020
- Primary completion3 Mar 2021
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- GeneOne Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673149
- Sponsor's protocol ID
- CoV2-001
- Status last verified
- Aug 2025
- First submitted
- 11 Dec 2020
- Last updated
- 3 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04673149
- Acronym / sponsor ID
- CoV2-001
- Conditions
- SARS-CoV-2
- Keywords
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- GeneOne Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Posted 3 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial will evaluate the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2(COVID-19) in healthy volunteers.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GLS-5310 0.6mg [Group 1a] | Experimental | Biological: GLS-53100.6mg of GLS-5310 will be intradermally administered on Day 0 and Week 8. |
| GLS-5310 1.2mg [Group 1b] | Experimental | Biological: GLS-53101.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8. |
| GLS-5310 1.2mg [Group 1c] | Experimental | Biological: GLS-53101.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 12. |
| Placebo [Group 2a] | Placebo comparator | Biological: PlaceboPlacebo will be intradermally administered on Day 0 and Week 8 (or Week 12). |
| GLS-5310 1.2mg [Group 2b] | Experimental | Biological: GLS-53101.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8 (or Week 12). |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLS-5310GLS-5310 DNA plasmid vaccine | Biological | GLS-5310 0.6mg [Group 1a], GLS-5310 1.2mg [Group 1b], GLS-5310 1.2mg [Group 1c], GLS-5310 1.2mg [Group 2b] |
| PlaceboPlacebo | Biological | Placebo [Group 2a] |
Primary outcome
Number of Serious Adverse Events
Time frame: Through 48 weeks post vaccination
2 secondary outcomes
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GLS-5310 in people with SARS-CoV-2, run by GeneOne Life Science, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Serious Adverse Events (time frame: Through 48 weeks post vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.