GLS-5310 Vaccine for the Prevention of SARS-CoV-2 (COVID-19)
- Registration Number
- NCT04673149
- Lead Sponsor
- GeneOne Life Science, Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 183
Inclusion Criteria
- Age 19 to 65 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
Exclusion Criteria
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GLS-5310 1.2mg [Group 1b] GLS-5310 1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8. Placebo [Group 2a] Placebo Placebo will be intradermally administered on Day 0 and Week 8 (or Week 12). GLS-5310 0.6mg [Group 1a] GLS-5310 0.6mg of GLS-5310 will be intradermally administered on Day 0 and Week 8. GLS-5310 1.2mg [Group 1c] GLS-5310 1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 12. GLS-5310 1.2mg [Group 2b] GLS-5310 1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8 (or Week 12).
- Primary Outcome Measures
Name Time Method Incidence of adverse events Through 48 weeks post vaccination solicited/unsolicited local and systemic AEs after vaccination
Geometric mean titer (GMT) of antigen-specific binding antibody titers Through 48 weeks post vaccination Endpoint titer of binding antibody in serum
- Secondary Outcome Measures
Name Time Method Geometric mean titer (GMT) of neutralizing antibody titers Through 48 weeks post vaccination Plaque-reduction neutralizing titer(PRNT) in serum at each timepoint
Evaluation of positive response rate of T cell responses induced by GLS-5310 DNA vaccine Through 48 weeks post vaccination T-cell response of antigen-specific interferon - gamma (IFN-γ) secretion in PBMC at each timepoint
Trial Locations
- Locations (1)
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of