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

NCT06265012 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PHV01-C-101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Marburg Virus Disease

Keywords

live, attenuated vaccine; Marburg virus; PHV01 (rVSV-MARV GP) vaccine; recombinant vesicular stomatitis virus

Outcome Measures

Primary Outcomes (5)

• Solicited Adverse Events (AEs)

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

  Study Days 1-15

• Unsolicited AEs

  Incidence and severity of unsolicited AEs

  Study Days 1-29

• Other AEs

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

  Study Days 1-181

• Immunogenicity, Antibodies (Ab)

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

  Injection through 28 days

• Immunogenicity, Neutralizing antibodies (NEUT)

  PsVNT50 and PsVNT80 MARV GP-specific neutralizing antibodies titers

  Injection through 28 days

Study Arms (4)

Group A, Low Dose PHV01

EXPERIMENTAL

Group A (10 subjects) PHV01 @ 10\^5 pfu/dose given once

Biological: PHV01

Group B, Medium Dose PHV01

EXPERIMENTAL

Group B (10 subjects) PHV01 @ 10\^6 pfu/dose given once

Biological: PHV01

Group C, Hjigh Dose PHV01

EXPERIMENTAL

Group C (10 subjects) PHV01 @ 10\^7 pfu/dose given once

Biological: PHV01

Group D, Placebo

PLACEBO COMPARATOR

Group D (6 subjects) Placebo given once

Biological: Placebo

Interventions

PHV01 BIOLOGICAL

Marburg virus vaccine

Group A, Low Dose PHV01; Group B, Medium Dose PHV01; Group C, Hjigh Dose PHV01

Placebo BIOLOGICAL

Lactated Ringer's Solution

Group D, Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Public Health Vaccines LLC: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (1)

CenExel RCA

Hollywood, Florida, 33024, United States

Location

MeSH Terms

Conditions

Marburg Virus Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Joan Fusco, PhD

  Public Health Vaccines

  STUDY CHAIR

• Richard Kenney, MD

  Public Health Vaccines

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single-blind
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: February 5, 2024
• Primary Completion: September 23, 2024
• Study Completion: September 23, 2024
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)