NCT06265012

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

A Phase 1 Randomized, Single-Blind, Placebo-Controlled, Ascending Dose Study to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP [Angola] (PHV01, MARV GP Vaccine) in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Public Health Vaccines LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participants will be randomly assigned to vaccine or placebo in four dose cohorts, starting with evaluation of safety using a sentinel group at each dose level, followed by dosing of the rest of the group in the next cohort. That next cohort will also dose the sentinel group with the next higher dose.

Conditions

• Marburg Virus Disease

Interventions

Type	Name	Description
BIOLOGICAL	PHV01	Marburg virus vaccine
BIOLOGICAL	Placebo	Lactated Ringer's Solution

Timeline

• Start date: 2024-02-05
• Primary completion: 2024-09-23
• Completion: 2024-09-23
• First posted: 2024-02-20
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study