A Phase 1, Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-SUDV-GP Vaccine in Adults in Good General Health
International AIDS Vaccine Initiative
Summary
A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUDV) Vaccine for the Prevention of SUDV Disease in Adults in Good General Health.
Description
This is a Phase 1, Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSVΔG-SUDV-GP Vaccine in Adults in Good General Health. Participants will be screened up to 28 days before Investigational Product (IP) administration and will be followed for 6 months after IP administration. The study will evaluate 4 different dose levels (2 X106 1X107, 2 X 107, 5 X 107) in 4 different participant groups for which enrollment will initiate sequentially. Starting with the lowest dose group, four sentinel participants will be enrolled i…
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria 1. Adults in good general health 2. Participants who are 18 to 50 years of age 3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study 4. In the opinion of the PI, participant understands risks and written informed consent will be obtained before any study-related procedures are performed 5. Willing to undergo HIV testing, risk reduction counseling, and receive HIV test results 6. All sexually active participants must consistently use male or female condoms with all sexual partners for 3 months following I…
Interventions
- BiologicalrVSVΔG-SUDV-GP
rVSVΔG-SUDV-GP
- OtherPlacebo
Placebo
Locations (3)
- George Washington UniversityWashington D.C., District of Columbia
- Johnson County Clin-TrialsLenexa, Kansas
- Brigham and Women's HospitalBoston, Massachusetts