A Phase 1 Study to Evaluate Safety & Immunogenicity of RVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects

A Phase 1 Randomized, Single Center, Double-Blind, Placebo-Controlled, Dose-Response and Open-Label or Single Blind Booster Study to Evaluate the Safety and Immunogenicity of RVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects

A Phase 1 Study to Evaluate the Safety and Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects

Study Overview

• Status: Completed
• Conditions: Nipah Virus Infection
• Intervention / Treatment: Biological: PHV02; Other: Placebo

Detailed Description

A Phase 1 Randomized, Single Center, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Safety and Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Johnson County Clin-Trials(JCCT)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• For Booster cohort only: received PHV02 (or placebo)
• Healthy, adult, male or non-pregnant, non-lactating females
• Given written informed consent
• No clinically significant health problems
• 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
• Agree to avoid employment in industry involved with livestock after vaccination through Day 29

Exclusion Criteria:

• Signs or symptoms of acute COVID-19 within 1 week before vaccination.
• Prior infection with Nipah virus or suspected Henipavirus
• 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, llamas 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 another investigational vaccine within 30 days or a licensed vaccine within 14 days (live vaccine within 30 days)
• 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 (athrocentesis if indicated by joint effusion), in both cases if acceptable to subject
• History of chronic autoimmune/autoinflammatory disease
• Elective surgery planned during the study period
• Subjects who have not adhered to and do not agree to adhere to local and institutional guidelines for COVID-19 prevention or testing
• Any subject from the Pioneer/Full cohort who experienced a hypersensitivity reaction to study vaccine or a single clinically significant Grade 3 adverse event or serious adverse event, unless deemed unrelated to vaccination, will be followed for safety and immunogenicity, but will not be eligible to enter the Booster Cohort

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Lactated Ringer's Solution. The placebo will be administered as a single intramuscular injection
Experimental: PHV02 2x10^5 pfu	Biological: PHV02; live, recombinant virus consisting of vesicular stomatitis virus (VSV; Indiana) with the gene for the Zaire ebolavirus glycoprotein (GP) (EBOV GP) replacing the gene for the VSV GP; in addition, the Nipah virus (NiV) G protein is also inserted and expressed. The vaccine is administered as a single intramuscular injection
Experimental: PHV02 2x10^6 pfu	Biological: PHV02; live, recombinant virus consisting of vesicular stomatitis virus (VSV; Indiana) with the gene for the Zaire ebolavirus glycoprotein (GP) (EBOV GP) replacing the gene for the VSV GP; in addition, the Nipah virus (NiV) G protein is also inserted and expressed. The vaccine is administered as a single intramuscular injection
Experimental: PHV02 2x10^7 pfu	Biological: PHV02; live, recombinant virus consisting of vesicular stomatitis virus (VSV; Indiana) with the gene for the Zaire ebolavirus glycoprotein (GP) (EBOV GP) replacing the gene for the VSV GP; in addition, the Nipah virus (NiV) G protein is also inserted and expressed. The vaccine is administered as a single intramuscular injection
Experimental: PHV02 5x10^8 pfu (Boost)	Biological: PHV02; live, recombinant virus consisting of vesicular stomatitis virus (VSV; Indiana) with the gene for the Zaire ebolavirus glycoprotein (GP) (EBOV GP) replacing the gene for the VSV GP; in addition, the Nipah virus (NiV) G protein is also inserted and expressed. The vaccine is administered as a single intramuscular injection
Experimental: PHV02 5x10^8 pfu (Prime)	Biological: PHV02; live, recombinant virus consisting of vesicular stomatitis virus (VSV; Indiana) with the gene for the Zaire ebolavirus glycoprotein (GP) (EBOV GP) replacing the gene for the VSV GP; in addition, the Nipah virus (NiV) G protein is also inserted and expressed. The vaccine is administered as a single intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by the Toxicity Grading Scale	for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials	42 days after vaccination
Number of participants with Nipah-specific antibody and neutralizing antibody responses as assessed by ELISA	for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials	29 days after vaccination

Collaborators and Investigators

• Sponsor: Public Health Vaccines LLC
• Collaborators: Coalition for Epidemic Preparedness Innovations
• Investigators: Study Director: Thomas Monath, MD, FASTMH, Crozet BioPharma; Principal Investigator: Carlos Fierro, MD, Johnson County Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: zoonotic disease; henipavirus; vesicular stomatitis vector; paramyxoviridae infection
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Paramyxoviridae Infections; Mononegavirales Infections; Henipavirus Infections
• Other Study ID Numbers: PHV02-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
• product manufactured in and exported from the U.S.: No