DNA vaccine against COVID-19 shows promise in early trial
NCT ID NCT04673149
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a new DNA vaccine called GLS-5310 for COVID-19 in 171 healthy adults aged 19 to 85. The vaccine is given as a shot under the skin and aims to teach the body to fight the virus. Researchers checked for side effects and measured immune responses like T cells and antibodies. The trial is complete, but results are not yet public.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GLS-5310 DNA vaccine
- What this could lead to
- If successful, this could lead to a new DNA-based vaccine option for COVID-19 that is easy to store and administer.
- What could go wrong
- This is an early-phase trial focused on safety and immune response, not yet proven to prevent infection. The vaccine may not generate strong enough immunity or could have unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
171 people
The number who actually took part.
- Started
-
Dec 2020
- Finished
-
May 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Korea University Guro Hospital
Seoul, 08308, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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