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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorInternational AIDS Vaccine Initiative

About this trial

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

Eligibility criteria

Qualifiers

Adults in good general health

Participants who are 18 to 50 years of age

Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study

Willing to undergo HIV testing, risk reduction counseling, and receive HIV test results

Disqualifiers

Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the Investigator makes the participant unsuitable for participation in the study

Individuals who are pregnant or breastfeeding

Bleeding disorder that was diagnosed by a physician

Infectious disease: Confirmed HIV-1 or HIV-2 infection, chronic active hepatitis B infection, current hepatitis C infection, active syphilis, or medically diagnosed long COVID 19 Syndrome. Also excluded are participants with active, serious infections requiring parenteral antibiotic, antiviral, or antifungal therapy within 30 days prior to enrollment.

Trial design

Treatments tested in this trial

  • rVSV∆G-MARV-GP
  • Placebo

Treatment groups

112 Participants
are divided into 2 treatment groups

Sponsors and collaborators

International AIDS Vaccine Initiative

Lead sponsor

Biomedical Advanced Research and Development Authority

Collaborator