GLS-5310 Vaccine in Healthy Volunteers as a Booster for SARS-CoV-2 (COVID-19)
Safety, Tolerability and Immunogenicity of GLS-5310 DNA Vaccine Given as a Booster to Those Previously Vaccinated Against SARS-CoV-2
1 other identifier
interventional
69
2 countries
3
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 covid19
Started May 2022
Longer than P75 for phase_1 covid19
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2022
CompletedFirst Posted
Study publicly available on registry
January 10, 2022
CompletedStudy Start
First participant enrolled
May 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedSeptember 13, 2023
February 1, 2023
8 months
January 5, 2022
September 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of adverse events
Solicited/unsolicited local and systemic AEs after vaccination
Through 48 weeks post vaccination
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 Outcomes (2)
Evaluation of positive response rate of T cell responses induced by GLS-5310 DNA vaccine
Through 48 weeks post vaccination
Evaluation of neutralizing antibody response induced by GLS-5310 relative to treatment arm
Through 48 weeks post vaccination
Study Arms (4)
GLS-5310 ID + GeneDerm 65 kPa, 30 seconds
EXPERIMENTALGLS-5310 ID + GeneDerm administered at Visit 1
GLS-5310 ID + GeneDerm 65 kPa, 30 seconds + GLS-5310 IN
EXPERIMENTALGLS-5310 ID + GeneDerm + GLS-5310 IN administered at Visit 1
GLS-5310 ID + GeneDerm 65 kPa, 15 seconds
EXPERIMENTALGLS-5310 ID + GeneDerm administered at Visit 1
GLS-5310 ID + GeneDerm 80 kPa, 30 seconds
EXPERIMENTALGLS-5310 ID + GeneDerm administered at Visit 1
Interventions
GLS-5310 DNA plasmid vaccine
Eligibility Criteria
You may qualify if:
- Age 18 to 65 years of age
- Able to provide informed consent
- 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
- 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
- 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
You may not qualify if:
- 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)
- Persons with a diagnosis of type 2 diabetes mellitus
- Persons with a diagnosis of chronic kidney disease
- Persons with a diagnosis of chronic obstructive pulmonary disease (COPD)
- Persons with a diagnosis of heart conditions to include heart failure, coronary artery disease, prior heart attack, cardiomyopathy
- Sickle cell disease
- Current or planned pregnancy during the study
- Currently breastfeeding
- Administration of an investigational agent within 90 days of the GLS-5310 booster dose
- Administration of a vaccine within 2 weeks prior to the GLS-5310 booster dose
- Administration of immune globulin within 6 months of enrollment
- Administration of an anti-TNFα inhibitor such as infliximab, adalimumab, etanercept, or anti-CD20 monoclonal antibody rituximab within 6 months from enrollment
- Current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater; or the equivalent dose of other systemic corticosteroids
- Treatment within the four weeks prior to enrollment with any drug intended for the prophylaxis or treatment of COVID-19
- Any prior treatment with an anti-SARS-CoV-2 monoclonal antibody or immune serum
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Meridian Clinical Research
Rockville, Maryland, 20854, United States
Meridian Clinical Research
Lincoln, Nebraska, 68510, United States
Clinical Research Puerto Rico
San Juan, PR, 00909, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2022
First Posted
January 10, 2022
Study Start
May 23, 2022
Primary Completion
January 10, 2023
Study Completion
December 1, 2023
Last Updated
September 13, 2023
Record last verified: 2023-02