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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05085639
Recruitment Status : Not yet recruiting
First Posted : October 20, 2021
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
GeneOne Life Science, Inc.

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
Covid19 Healthy 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : December 2022

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




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Through 56 weeks post vaccination ]
    solicited/unsolicited local and systemic AEs

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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):

  29. History of chronic rhinosinusitis
  30. History of nasal septal defect or deviated nasal septum
  31. History of cleft palate
  32. History of nasal polyps
  33. History of other disorders that, in the opinion of the investigator, may adversely affect administration of intranasal vaccine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085639


Contacts
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Contact: Medical Monitor 610-707-5671 jmaslow@genels.us
Contact: Project Manager 914-606-1199 dkane@genels.us

Locations
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Puerto Rico
Clinical Research Puerto Rico
San Juan, Puerto Rico, 00909
Principal Investigator: Javier Morales, MD         
University of Puerto Rico
San Juan, Puerto Rico, 00963
Contact: Ileana Boneta    787-767-9192      
Principal Investigator: Jorge Santana, MD         
Sponsors and Collaborators
GeneOne Life Science, Inc.
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Responsible Party: GeneOne Life Science, Inc.
ClinicalTrials.gov Identifier: NCT05085639    
Other Study ID Numbers: CoV2-002
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021

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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:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases