Study to Evaluate Safety and Immunogenicity of a Prime-Boost Regimen of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Nipah Virus Infection

In brief

The goal of this clinical trial is to test the safety and immunogenicity of PHV02 live, attenuated recombinant vesicular stomatitis virus vaccine expressing the Nipah Virus glycoprotein in healthy adult subjects. The main questions it aims to answer are: * which doses of PHV02 are safe to administer to and well-tolerated by healthy adult subjects as a 2 dose regimen given 1 month apart? * what is the immunologic response (Nipah-specific IgG ELISA antibody and neutralizing antibodies) to each dose level after a 2-dose regimen given 1 month apart? Participants will receive 2 intramuscular injections of PHV02 (2x105, 2x106, and 2x107 plaque-forming units \[pfu\]) or placebo on Day 1 and Day 29 and will be followed for 197 days.

Key facts

Study ID: NCT06221813
Run by: Public Health Vaccines LLC
People needed: 120
Starts: 2024-01-26
Expected to finish: 2024-10-02
Last updated by the study team: 2025-06-08

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Healthy, adult, male or non-pregnant, non-lactating females
Given written informed consent
No clinically significant health problems
Negative test for SARS-CoV-2
Agree to avoid conception through Day 57
Agree to minimize blood and body fluid exposures to others after vaccination through Day 57
Agree to avoid exposure to immunocompromised persons after vaccination through Day 57
Agree to avoid employment in industry involved with livestock after vaccination through Day 57

You may not qualify if…

Prior infection with Nipah virus, related Henipaviruses or Ebola virus
Prior infection with vesicular stomatitis virus (VSV)
Received VSV-vectored vaccine or Ebola vaccine
BMI < 18.5 or ≥ 35
Healthcare worker with direct physical contact with patients
Childcare worker in direct contact with children 5 years old or younger
Household contact who is immunodeficient, or on immunosuppressive medication
Hands-on food preparation job
Primary care or treatment of cattle, horses, or swine
Hepatitis B, hepatitis C, HIV-1, HIV-2, 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, or planned receipt within 196 days after randomization, or ongoing participation in another interventional clinical trial.
Receipt of licensed non-live vaccines within 14 days of planned study immunization (30 days for live vaccines) or planned receipt of non-live or live vaccine within 60 days after first study immunization (30 days after the 2nd vaccination).
Known allergy to components of PHV02
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 120 days preceding study
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 ACT (Anaheim Clinical Trials) — Anaheim, California, United States
Cenexel RCA (Research Centers of America) — Hollywood, Florida, United States
Cenexel JBR (JBR Clinical Research) — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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