CompletedPhase 1

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

United States36 participantsStarted 2024-02-05

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy, adult, male or non-pregnant, non-lactating females, age 18-60 years * Given written informed consent * No clinically significant health problems * Negative test for SARS-CoV-2 * Agree to avoid conception through Day 29 * Agree to minimize blood and body fluid exposures to others after vaccination through Day 29 * Agree to avoid exposure to immunocompromised persons after vaccination through Day 29 Exclusion Criteria: * Prior infection with Marburg virus, related filovirus, or Ebola virus * Prior infection with vesicular stomatitis virus (VSV) * Received any VSV-vectored vaccine * BMI of ≥ 35 * Household contact who is immunodeficient, or on immunosuppressive medication * Hepatitis B, hepatitis C, HIV-1, HIV-2, history of long COVID, diabetes, atopic dermatitis (eczema), chronic inflammatory disease, autoimmune or autoinflammatory disorder, malignancy, chronic or active neurologic disorder * History of severe reactions to any vaccine or history of severe allergies * Receipt of investigational product up to 30 days prior to randomization * Receipt of licensed or authorized non-live vaccines within 14 days of planned study immunization (30 days for live vaccines). * Known allergy to components of PHV01 * Injection sites obscured by tattoos or physical condition * Significant psychiatric or medical condition or laboratory abnormality on screening * History of Guillain Barre Syndrome or any chronic or acute neurological disorder * Alcohol or illic…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Solicited Adverse Events (AEs)

Timeframe: Study Days 1-15

Unsolicited AEs

Timeframe: Study Days 1-29

Other AEs

Timeframe: Study Days 1-181

Immunogenicity, Antibodies (Ab)

Timeframe: Injection through 28 days

Immunogenicity, Neutralizing antibodies (NEUT)

Timeframe: Injection through 28 days

Trial details

NCT IDNCT06265012

SponsorPublic Health Vaccines LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-23

View on ClinicalTrials.gov More Marburg Virus Disease trials