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

June 4, 2025 updated by: Public Health Vaccines LLC

A Phase 1b Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Prime-Boost Regimen of Three Dose Levels of PHV02, a Nipah Virus Vaccine Candidate (rVSV-ΔG-EBOV GP-NiVG) in Healthy Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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 Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • CenExel ACT (Anaheim Clinical Trials)
    • Florida
      • Hollywood, Florida, United States, 33024
        • Cenexel RCA (Research Centers of America)
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Cenexel JBR (JBR Clinical Research)

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
  • 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

Exclusion Criteria:

  • 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

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 (first 60 subjects) PHV02 high dose
Biological: PHV02
Nipah virus vaccine
Experimental: Cohort 1 (first 60 subjects) PHV02 medium dose
Biological: PHV02
Nipah virus vaccine
Experimental: Cohort 1 (first 60 subjects) PHV02 low dose
Biological: PHV02
Nipah virus vaccine
Placebo Comparator: Cohort 1 (first 60 subjects) Placebo
Biological: Lactated Ringer's
Placebo
Experimental: Cohort 2 (next 60 subjects) PHV02 high dose
Biological: PHV02
Nipah virus vaccine
Experimental: Cohort 2 (next 60 subjects) PHV02 medium dose
Biological: PHV02
Nipah virus vaccine
Experimental: Cohort 2 (next 60 subjects) PHV02 low dose
Biological: PHV02
Nipah virus vaccine
Placebo Comparator: Cohort 2 (next 60 subjects) Placebo
Biological: Lactated Ringer's
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with neurologic AEs
Time Frame: Study Days 1-57
Study Days 1-57
Percentage of participants with medically-attended AEs (MAAEs) and serious AEs (SAEs)
Time Frame: From time of injection through final study visit (Day 197)
From time of injection through final study visit (Day 197)
Proportion of participants with recombinant vesicular stomatitis virus (rVSV) RNA (Cohort 1 only) in plasma, urine and saliva
Time Frame: From time of injection through Day 43
From time of injection through Day 43
Proportion of participants who seroconvert compared to Day 1
Time Frame: Day 29 and Day 57
Day 29 and Day 57
Geometric mean titers of IgG and ELISA neutralizing antibodies
Time Frame: Day 1, 29, 57
Day 1, 29, 57
Percentage of participants with local injection site and systemic adverse events (AEs)
Time Frame: 14 days after each dose
14 days after each dose
Percentage of participants with joint related symptoms, rash and unsolicited AEs
Time Frame: 28 days after each dose
28 days after each dose

Collaborators and Investigators

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

Sponsor

Public Health Vaccines LLC

Collaborators

Coalition for Epidemic Preparedness Innovations

Investigators

  • Study Chair: Joan Fusco, PhD, Public Health Vaccines
  • Study Director: Thomas P Monath, MD, Quigley Biopharma
  • Study Director: Gray P Heppner, MD, Quigley Biopharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 26, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

October 2, 2024

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 8, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHV02-C-102

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

product manufactured in and exported from the U.S.

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.

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