Phase 1 Randomized, Observer-Blind, Placebo-Controlled Dose-Escalation Study to Assess Safety and Immune Response of rVSVG-MARV-GP Vaccine in Healthy Adults Aged 18 to 50

What this Trial Is About

Researchers are studying the safety and immune response of the rVSV6G-MARV-GP vaccine in adults who are in good general health. This Phase 1 clinical trial uses a randomized, observer-blind, placebo-controlled design to evaluate different dose levels of the vaccine. The study focuses on understanding how the vaccine affects the body and its ability to trigger an immune response against Marburg Virus Disease. Participants will receive one of four different dose levels of the rVSV6G-MARV-GP vaccine or a placebo. The dosing starts at the lowest level and gradually increases after safety checks at each stage. About 112 adults will be involved, and the vaccine or placebo will be given following a careful dose-escalation plan to ensure safety at each step. During the study, participants will be monitored closely for safety, including common side effects and serious adverse events up to seven months after vaccination. Their immune response will be measured through blood tests over six months to assess antibody levels and neutralization. The trial includes regular follow-up visits and testing, with a total participation duration extending up to several months to evaluate both short and longer-term effects of the vaccine.

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