GLS-5310 Vaccine for the Prevention of SARS-CoV-2 (COVID-19)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GLS-5310 0.6mg [Group 1a] 0.6mg of GLS-5310 will be intradermally administered on Day 0 and Week 8. |
Biological: GLS-5310
GLS-5310 DNA plasmid vaccine
|
| Experimental: GLS-5310 1.2mg [Group 1b] 1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8. |
Biological: GLS-5310
GLS-5310 DNA plasmid vaccine
|
| Experimental: GLS-5310 1.2mg [Group 1c] 1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 12. |
Biological: GLS-5310
GLS-5310 DNA plasmid vaccine
|
| Placebo Comparator: Placebo [Group 2a] Placebo will be intradermally administered on Day 0 and Week 8 (or Week 12). |
Biological: Placebo
Placebo
|
| Experimental: GLS-5310 1.2mg [Group 2b] 1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8 (or Week 12). |
Biological: GLS-5310
GLS-5310 DNA plasmid vaccine
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Geometric mean titer (GMT) of neutralizing antibody titers [Through 48 weeks post vaccination]
Plaque-reduction neutralizing titer(PRNT) in serum at each timepoint
Other Outcome Measures
- Determine IgG antibody responses after a single dose of vaccine related to treatment arm [Through 1 year post vaccination]
Endpoint titer of binding antibody in serum at each timepoint
- Measure survival rate of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2. [Through 1 year post vaccination]
Survival rate
- Persistence of immune responses following vaccination with GLS-5310 [Through 1 year post vaccination]
Endpoint titer of binding antibody in serum at each timepoint Plaque-reduction neutralizing titer in serum at each timepoint T-cell response of antigen-specific interferon - gamma (IFN-γ) secretion in PBMC at each timepoint
- Determine the extent of immune boosting for participants who are seropositive at baseline following vaccination with GLS-5310 [Through 1 year post vaccination]
Change from baseline in binding antibody titers Change from baseline in T-cell response of antigen-specific interferon - gamma (IFN-γ) Change from baseline in plaque-reduction neutralizing titer(PRNT) in serum
- Measure viral load in organs, including blood, of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2. [Through 1 year post vaccination]
viral load measurement of blood and major organs
- Perform histologic examination of organs of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2. [Through 1 year post vaccination]
pathological examination of organs
Eligibility Criteria
Criteria
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
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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
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Respiratory disease (ex. Asthma, Chronic obstructive lung disease)
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Cardiovascular disease (ex. myocardial ischemia, congestive heart failure, cardiomyopathy, clinically significant arrhythmia)
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Hypertension (Systolic pressure >150mmHg or Diastolic pressure >95mmHg)
-
Confirmed Diabetes
-
Severe allergic reaction or anaphylactic reaction after vaccination in the past
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Immunosuppresion including immunodeficiency disease or family history
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Positive of serum test at screening (Hepatitis B, Hepatitis A, HIV, Hepatitis C)
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Baseline screening lab(s) with Non Clinical Significant abnormality
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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
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History of PCR-confirmed infection with SARS-CoV-2 at screening
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Korea University Guro Hospital | Seoul | Korea, Republic of | 08308 |
Sponsors and Collaborators
- GeneOne Life Science, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CoV2-001