GLS-5310 Vaccine for the Prevention of SARS-CoV-2 (COVID-19)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Sars Cov 2
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 19 years and 65 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04673149
- Collaborators
- Not Provided
- Investigators
- Not Provided
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