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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-31

Study Completion Date

2023-05-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Phase III

NCT05096845

COVID-19 Pandemic

UNKNOWN PHASE3

Recombinant New Coronavirus Vaccine (CHO Cells) to Prevent SARS-CoV-2（COVID-19） Phase I Clinical Trial (3~17 Years Old)

NCT04961359

Coronavirus

COMPLETED PHASE1

A Clinical Trial to Evaluate the Recombinant SARS-CoV-2 Vaccine (CHO Cell) for COVID-19

NCT04869592

COVID-19

COMPLETED PHASE1/PHASE2

A Global Multi-center Clinical Study of SARS-CoV-2 mRNA Vaccine for the Prevention of COVID-19

NCT05682638

SARS-CoV-2

RECRUITING PHASE3

Safety and Immunogenicity of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19

NCT05313022

COVID-19

UNKNOWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV-2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Intervention Type BIOLOGICAL

GLS-5310 DNA plasmid vaccine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GLS-5310

GLS-5310 DNA plasmid vaccine

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes