COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2024-02-05
Study Completion:2024-09-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06265012

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.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy, adult, male or non-pregnant, non-lactating females, age 18-60 years
  2. * Given written informed consent
  3. * No clinically significant health problems
  4. * Negative test for SARS-CoV-2
  5. * Agree to avoid conception through Day 29
  6. * Agree to minimize blood and body fluid exposures to others after vaccination through Day 29
  7. * Agree to avoid exposure to immunocompromised persons after vaccination through Day 29
  1. * Prior infection with Marburg virus, related filovirus, or Ebola virus
  2. * Prior infection with vesicular stomatitis virus (VSV)
  3. * Received any VSV-vectored vaccine
  4. * BMI of ≥ 35
  5. * Household contact who is immunodeficient, or on immunosuppressive medication
  6. * 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
  7. * History of severe reactions to any vaccine or history of severe allergies
  8. * Receipt of investigational product up to 30 days prior to randomization
  9. * Receipt of licensed or authorized non-live vaccines within 14 days of planned study immunization (30 days for live vaccines).
  10. * Known allergy to components of PHV01
  11. * Injection sites obscured by tattoos or physical condition
  12. * Significant psychiatric or medical condition or laboratory abnormality on screening
  13. * History of Guillain Barre Syndrome or any chronic or acute neurological disorder
  14. * Alcohol or illicit drug abuse within past 5 years
  15. * Pregnant or lactating female
  16. * Administration of blood or IgG within 60 days preceding study
  17. * Administration of systemic chronic immunosuppressants (defined as more than 14 days) or other immune modifying drugs within 6 months of study entry
  18. * History of blood donation within 60 days of study
  19. * 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
  20. * Elective surgery planned during the study period

Contacts and Locations

Principal Investigator

Joan Fusco, PhD
STUDY_CHAIR
Public Health Vaccines
Richard Kenney, MD
STUDY_DIRECTOR
Public Health Vaccines

Study Locations (Sites)

CenExel RCA
Hollywood, Florida, 33024
United States

Collaborators and Investigators

Sponsor: Public Health Vaccines LLC

  • Joan Fusco, PhD, STUDY_CHAIR, Public Health Vaccines
  • Richard Kenney, MD, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2024-02-05
Study Completion Date2024-09-23

Study Record Updates

Study Start Date2024-02-05
Study Completion Date2024-09-23

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Marburg Virus Disease