drugset / Trial / NCT06265012

Study to Evaluate the Recombinant VSV (rVSV)-Marburg Virus Vaccine Candidate (PHV01) in Healthy Adult Subjects

NCT06265012 ↗

RandomizedSequentialQuadruple-blindPrevention

Summary

This is a Phase 1 randomized, single-blind, placebo-controlled, ascending dose study to evaluate the safety and immunogenicity of rVSV∆G-MARV-GP \[Angola\] (PHV01, Marburg Virus glycoprotein \[MARV GP\] Vaccine) in healthy adults. PHV01 is a live, attenuated rVSV vaccine expressing the MARV GP. The main questions it aims to answer are: * Which dose of PHV01 is safe to administer to, and well-tolerated by healthy adult subjects? * What is the immunologic response (Marburg-specific Immunoglobulin G (IgG) ELISA antibody and neutralizing antibodies) to each dose level? Participants will receive 1 intramuscular injection of PHV01 or placebo on Day 1 and will be followed for 181 days.

Timeline

Start
2024-02-05
Primary completion
2024-09-23
Completion
2024-09-23

Drugs

EvaluationDrugModalityDoseRoute
Subject PHV01 Vaccine 100000 unknown Intramuscular
Subject PHV01 Vaccine 1e+06 unknown Intramuscular
Subject PHV01 Vaccine 1e+07 unknown Intramuscular