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

Sponsor
GeneOne Life Science, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05085639
Collaborator
(none)
30
Enrollment
2
Locations
4
Arms
13
Anticipated Duration (Months)
15
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase I study of the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2 (COVID-19)

Condition or Disease Intervention/Treatment Phase
  • Biological: GLS-5130
  • Biological: Placebo
 Phase 1

Detailed Description

This Phase I, randomized, placebo-controlled, dose-ranging, single-blind study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine administered intradermally (ID) with or without concomitant intranasal (IN) administration of GLS-5310. Vaccine delivered ID will either be performed by Mantoux injection and followed by suction applied to the skin surface using the Gene-Derm device or Mantous injection alone without applied suction. Vaccine delivered IN will be administered using the MAD300 atomizer.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Phase I Study of the Safety, Tolerability and Immunogenicity of GLS-5310 DNA Vaccine Against SARS-CoV-2
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: GLS-5310 1.2 mg (Group 1)

GLS-5310 1.2 mg (ID + Gene-Derm) at Day 0 and Week 8

Biological: GLS-5130
GLS-5310 DNA plasmid vaccine
Experimental: GLS-5310 2.4 mg (Group 2)

GLS-5310 1.2 mg (ID + Gene-Derm) + 1.2 mg (IN) at Day 0 and Week 8

Biological: GLS-5130
GLS-5310 DNA plasmid vaccine
Experimental: GLS-5310 1.2 mg (Group 3)

GLS-5310 1.2 mg ID at Day 0 and Week 8

Biological: GLS-5130
GLS-5310 DNA plasmid vaccine
Placebo Comparator: Placebo (Group 4)

Placebo (ID + Gene-Derm) at Day 0 and Week 8

Biological: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events [Through 56 weeks post vaccination]

    solicited/unsolicited local and systemic AEs

  2. Geometric mean titer (GMT) of antigen specific antibody titers [Through 56 weeks post vaccination]

    Endpoint titer of binding antibody in serum

Secondary Outcome Measures

  1. Evaluation of positive response rate of T cell responses induced by GLS-5310 [Through 56 weeks post vaccination]

    T-cell response of antigen-specific interferon - gamma (IFN-γ) secretion in PBMC at each timepoint

  2. Geometric mean titer (GMT) of neutralizing antibody titers [Through 56 weeks post vaccination]

    Plaque-reduction neutralizing titer(PRNT) in serum at each timepoint

Other Outcome Measures

  1. Determine IgG antibody responses after a single dose of GLS-5310 related to treatment arm [Through 56 weeks post vaccination]

    Endpoint titer of binding antibody in serum at each timepoint

  2. Determine IgA antibody responses following vaccination of GLS-5310 related to treatment arm [Through 56 weeks post vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion criteria:

  1. Age 18 to 65 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 during the study

  5. Negative test result for the presence of SARS-CoV-2 IgM and IgG antibodies, which indicate recent or prior infection

Exclusion criteria:

  1. Persons involved in the care of patients with COVID-19 and health care workers considered, in the opinion of the investigator, to be at increased risk of infection from SARS-CoV-2

  2. Persons with symptoms in the past 2 weeks consistent with possible acute SARS-CoV-2 infection to include fever, loss of smell or taste

  3. Persons diagnosis of type 2 diabetes mellitus

  4. Persons with a diagnosis of chronic kidney disease

  5. Persons with a diagnosis of chronic obstructive pulmonary disease (COPD)

  6. Persons with a diagnosis of heart conditions to include heart failure, coronary artery disease, prior heart attack, cardiomyopathy

  7. Obesity (BMI of 30 kg/m2 or greater)

  8. Sickle cell disease

  9. Current or former smoker

  10. Current or planned pregnancy during the study

  11. Currently breastfeeding

  12. Current or past participation in a coronavirus (MERS-CoV, SARS-CoV-2) vaccine study, or receipt of a SARS-CoV-2 vaccine that has been approved by the FDA, including vaccines that have received Emergency Use Authorization (EUA)

  13. Administration of an investigational agent within 90 days of the 1st dose

  14. Administration of a vaccine within 2 weeks prior to the 1st dose

  15. Administration of immune globulin within 6 months of enrollment

  16. Administration of an anti-TNFα inhibitor such as infliximab, adalimumab, etanercept, or anti-CD20 monoclonal antibody rituximab within 6 months from enrollment

  17. Current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater; or the equivalent dose of other systemic corticosteroids

  18. Treatment within the four weeks prior to enrollment with any drug intended for the prophylaxis or treatment of COVID-19

  19. Any prior treatment with an anti-SARS-CoV-2 monoclonal antibody or immune serum

  20. Prior treatment with an anti-IL-6 inhibitor, anti-IL-1 inhibitor, anti-TNF monoclonal antibody, or anti-JAK inhibitor (see Appendix B exclusionary period for specific drugs)

  21. History of malignancy

  22. History of transplantation (any organ or bone marrow)

  23. Current or planned chemotherapy treatment for hematologic or solid tumor during study period

  24. History of other congenital or acquired immunodeficiency, excluding those with HIV infection who are taking highly active antiretroviral therapy and who have documentation of undetectable serum viral load

  25. History of PCR-confirmed infection with SARS-CoV-2

  26. Not willing to allow storage and future use of samples for SARS-CoV-2 related research and who have a CD4 count > 200 cells/µL on two measures at least 3 months apart

  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

Exclusion criteria (ID + IN only):

  1. History of chronic rhinosinusitis

  2. History of nasal septal defect or deviated nasal septum

  3. History of cleft palate

  4. History of nasal polyps

  5. History of other disorders that, in the opinion of the investigator, may adversely affect administration of intranasal vaccine

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Research Puerto Rico San Juan Puerto Rico 00909
2 University of Puerto Rico San Juan Puerto Rico 00963

Sponsors and Collaborators

  • GeneOne Life Science, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GeneOne Life Science, Inc.
ClinicalTrials.gov Identifier:
NCT05085639
Other Study ID Numbers:
  • CoV2-002
First Posted:
Oct 20, 2021
Last Update Posted:
Oct 20, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GeneOne Life Science, Inc.
Vaccine
DNA
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Oct 20, 2021