NCT07425821

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed 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 IAVI C104 study will look at the safety, tolerability and immunogenicity of the rVSV Marburg virus vaccine.

Conditions

• Marburg Virus Disease

Interventions

Type	Name	Description
BIOLOGICAL	rVSV∆G-MARV-GP	rVSV∆G-MARV-GP
OTHER	Placebo	Placebo

Timeline

• Start date: 2026-03-27
• Primary completion: 2027-11-01
• Completion: 2028-07-01
• First posted: 2026-02-23
• Last updated: 2026-04-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study