GLS-5310 Vaccine in Healthy Volunteers as a Booster for SARS-CoV-2 (COVID-19)

Healthy Clinical Trial

Official title:

Safety, Tolerability and Immunogenicity of GLS-5310 DNA Vaccine Given as a Booster to Those Previously Vaccinated Against SARS-CoV-2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05182567
• Other study ID #: CoV2-008
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 23, 2022
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: GeneOne Life Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase I study to assess the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine given as a booster to those previously vaccinated against SARS-CoV-2

Description:

This Phase I, randomized, placebo-controlled study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine administered intradermally (ID) with or without concomitant intranasal (IN) administration given as a heterologous booster dose to those previously vaccinated against SARS-CoV-2.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 69
• Est. completion date: December 2023
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 and agree to refrain from obtaining a booster vaccination with a non-study vaccine through to the 1 month post-boost vaccination visit

4. For women of childbearing potential, able and willing to use an approved form of pregnancy prevention for at least 4 weeks from study drug administration

5. Completion of a prior vaccination series with either the BNT162b2, mRNA-1273, or Ad26.CoV.S vaccines, with or without subsequent booster vaccination, with most recent vaccination at least 6 months prior to study entry

Exclusion Criteria:

1. Persons with symptoms in the past 2 weeks consistent with possible acute SARS-CoV-2 infection (https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html)

2. Persons with a diagnosis of type 2 diabetes mellitus

3. Persons with a diagnosis of chronic kidney disease

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

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

6. Sickle cell disease

7. Current or planned pregnancy during the study

8. Currently breastfeeding

9. Administration of an investigational agent within 90 days of the GLS-5310 booster dose

10. Administration of a vaccine within 2 weeks prior to the GLS-5310 booster dose

11. Administration of immune globulin within 6 months of enrollment

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

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

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

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

16. 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)

17. History of malignancy

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

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

20. 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 and who have a CD4 count > 200 cells/µL on two measures at least 3 months apart

21. Not willing to allow storage and future use of samples for coronavirus-related research and/or vaccine development

22. Prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness

23. 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

24. History of chronic rhinosinusitis

25. History of nasal septal defect or deviated nasal septum

26. History of cleft palate

27. History of nasal polyps

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

Related Conditions & MeSH terms

• COVID-19
• Healthy

Intervention

Drug:
• GLS-5310 (Group 1)
GLS-5310 DNA plasmid vaccine
• GLS-5310 (Group 2)
GLS-5310 DNA plasmid vaccine
• GLS-5310 (Group 3)
GLS-5310 DNA plasmid vaccine
• GLS-5310 (Group 4)
GLS-5310 DNA plasmid vaccine

Locations

Country	Name	City	State
Puerto Rico	Clinical Research Puerto Rico	San Juan
United States	Meridian Clinical Research	Lincoln	Nebraska
United States	Meridian Clinical Research	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
GeneOne Life Science, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	Solicited/unsolicited local and systemic AEs after vaccination	Through 48 weeks post vaccination
Primary	Determine antibody responses after a single dose of vaccine	The fold change of SARS-CoV-2 Spike binding antibodies 1-month post-booster	Through 48 weeks post vaccination
Secondary	Evaluation of positive response rate of T cell responses induced by GLS-5310 DNA vaccine		Through 48 weeks post vaccination
Secondary	Evaluation of neutralizing antibody response induced by GLS-5310 relative to treatment arm		Through 48 weeks post vaccination