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

February 20, 2024 updated by: Public Health Vaccines LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A, Low Dose PHV01
Group A (10 subjects) PHV01 @ 10^5 pfu/dose
Biological: PHV01
Marburg virus vaccine
Experimental: Group B, Medium Dose PHV01
Group B (10 subjects) PHV01 @ 10^6 pfu/dose
Biological: PHV01
Marburg virus vaccine
Experimental: Group C, Hjigh Dose PHV01
Group C (10 subjects) PHV01 @ 10^7 pfu/dose
Biological: PHV01
Marburg virus vaccine
Placebo Comparator: Group D, Placebo
Group D (6 subjects) Placebo
Biological: Placebo
Lactated Ringer's Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unsolicited AEs
Time Frame: Study Days 1-29
Incidence and severity of unsolicited AEs
Study Days 1-29
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
Study Days 1-15
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)
Study Days 1-181
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
Injection through 28 days
Immunogenicity, Neutralizing antibodies (NEUT)
Time Frame: Injection through 28 days
PsVNT50 and PsVNT80 MARV GP-specific neutralizing antibodies titers
Injection through 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Public Health Vaccines LLC

Collaborators

Biomedical Advanced Research and Development Authority

Investigators

  • Study Chair: Joan Fusco, PhD, Public Health Vaccines
  • Study Director: Richard Kenney, MD, Public Health Vaccines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2024

Primary Completion (Estimated)

April 17, 2024

Study Completion (Estimated)

September 16, 2024

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHV01-C-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Marburg Virus Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe