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Completed

NCT Number: NCT06265012

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

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.

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Key information

Conditions

Marburg Virus Disease Animal Diseases Filoviridae Infections Hemorrhagic Fevers, Viral Infections Monkey Diseases Mononegavirales Infections Primate Diseases RNA Virus Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CenExel RCA

Hollywood, Florida, 33024, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 illicit drug abuse within past 5 years
  • Pregnant or lactating female
  • Administration of blood or IgG within 60 days preceding study
  • Administration of systemic chronic immunosuppressants (defined as more than 14 days) or other immune modifying drugs within 6 months of study entry
  • History of blood donation within 60 days of study
  • Unwilling to undergo diagnostic evaluation of rash (skin biopsy, if indicated) or joint symptoms (arthrocentesis if indicated by joint effusion), in both cases if acceptable to subject
  • Elective surgery planned during the study period

Treatment and study plan

PHV01

Biological

Marburg virus vaccine

Placebo

Biological

Lactated Ringer's Solution

Primary outcomes

  1. Solicited Adverse Events (AEs)

    Time frame: Study Days 1-15

    Incidence and severity of solicited injection site [(arm pain, local tenderness, erythema (redness), and induration (swelling/firmness)] and systemic AEs

  2. Unsolicited AEs

    Time frame: Study Days 1-29

    Incidence and severity of unsolicited AEs

  3. Other AEs

    Time frame: Study Days 1-181

    Incidence and severity of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)

  4. Immunogenicity, Antibodies (Ab)

    Time frame: Injection through 28 days

    Geometric mean titers (GMT) of Marburg GP protein-specific IgG antibody as measured by enzyme-linked immunosorbent assay (ELISA) on days 1 and 29

  5. Immunogenicity, Neutralizing antibodies (NEUT)

    Time frame: Injection through 28 days

    PsVNT50 and PsVNT80 MARV GP-specific neutralizing antibodies titers

Sponsors and collaborators

Lead sponsor

Public Health Vaccines LLC

Industry

Collaborators

  • Biomedical Advanced Research and Development Authority

Registry information

Official study title

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

Acronym: PHV01

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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