A Phase 1 Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health
International AIDS Vaccine Initiative
Summary
A Phase 1 Randomized, Observer Blind, Placebo-controlled, Dose-escalation and dose expansion Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health
Description
This is a observer-blind, Phase 1 Randomized, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health. The study is a dose escalation study that will administer 4 different dose levels to 4 different groups. The lowest dose level will be given and then a safety assessment will occur before escalation to the next dose level. This gradual dosing followed by a safety assessment will be repeated at each dose level. Approximately 112 participants will be given vaccine (rVSV∆G-MARV-GP) or placebo. This…
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. Willing to undergo HIV testing, risk reduction counseling, and receive HIV test results 5. All sexually active participants must consistently use male or female condoms with all sexual partners for 3 months following IP administration 6. All individuals of childbearing potential engaging in sexual activity that could lead to pregnancy must commit to use an effective meth…
Interventions
- BiologicalrVSV∆G-MARV-GP
rVSV∆G-MARV-GP
- OtherPlacebo
Placebo
Locations (2)
- George Washington UniversityWashington D.C., District of Columbia
- Johnson County Clin-TrialsLenexa, Kansas