Study to Evaluate the Recombinant VSV (rVSV)-Marburg Virus Vaccine Candidate (PHV01) in Healthy Adult Subjects
Completed · Phase 1 · Has a placebo group
Conditions studied: Marburg Virus Disease
In brief
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.
Key facts
- Study ID
- NCT06265012
- Run by
- Public Health Vaccines LLC
- People needed
- 36
- Starts
- 2024-02-05
- Expected to finish
- 2024-09-23
- Last updated by the study team
- 2025-09-05
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
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
- 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
Where it is running
- CenExel RCA — Hollywood, Florida, United States
Full record on ClinicalTrials.gov
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