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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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SARS-CoV-2

Intervention / Treatment
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* Biological: GLS-5310
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLS-5310 0.6mg [Group 1a]<br>0.6mg of GLS-5310 will be intradermally administered on Day 0 and Week 8. | Biological: GLS-5310<br>* GLS-5310 DNA plasmid vaccine<br>|
| Experimental: GLS-5310 1.2mg [Group 1b]<br>1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8. | Biological: GLS-5310<br>* GLS-5310 DNA plasmid vaccine<br>|
| Experimental: GLS-5310 1.2mg [Group 1c]<br>1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 12. | Biological: GLS-5310<br>* GLS-5310 DNA plasmid vaccine<br>|
| Placebo Comparator: Placebo [Group 2a]<br>Placebo will be intradermally administered on Day 0 and Week 8 (or Week 12). | Biological: Placebo<br>* Placebo<br>|
| Experimental: GLS-5310 1.2mg [Group 2b]<br>1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8 (or Week 12). | Biological: GLS-5310<br>* GLS-5310 DNA plasmid vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | solicited/unsolicited local and systemic AEs after vaccination | Through 48 weeks post vaccination | 
| Geometric mean titer (GMT) of antigen-specific binding antibody titers | Endpoint titer of binding antibody in serum | Through 48 weeks post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of positive response rate of T cell responses induced by GLS-5310 DNA vaccine | T-cell response of antigen-specific interferon - gamma (IFN-γ) secretion in PBMC at each timepoint | Through 48 weeks post vaccination | 
| Geometric mean titer (GMT) of neutralizing antibody titers | Plaque-reduction neutralizing titer(PRNT) in serum at each timepoint | Through 48 weeks post vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19