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

NCT05178901 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PHV02-C-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nipah Virus Infection

Keywords

henipavirus; vesicular stomatitis vector; paramyxoviridae infection; zoonotic disease

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (6)

PHV02 2x10^5 pfu

EXPERIMENTAL

Biological: PHV02

PHV02 2x10^6 pfu

EXPERIMENTAL

Biological: PHV02

PHV02 2x10^7 pfu

EXPERIMENTAL

Biological: PHV02

Placebo

PLACEBO COMPARATOR

Other: Placebo

PHV02 5x10^8 pfu (Boost)

EXPERIMENTAL

Biological: PHV02

PHV02 5x10^8 pfu (Prime)

EXPERIMENTAL

Biological: PHV02

Interventions

PHV02 BIOLOGICAL

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

PHV02 2x10^5 pfu; PHV02 2x10^6 pfu; PHV02 2x10^7 pfu; PHV02 5x10^8 pfu (Boost); PHV02 5x10^8 pfu (Prime)

Placebo OTHER

Lactated Ringer's Solution. The placebo will be administered as a single intramuscular injection

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Public Health Vaccines LLC: lead
• Coalition for Epidemic Preparedness Innovations: collaborator

Study Sites (1)

Johnson County Clin-Trials(JCCT)

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

Henipavirus Infections; Paramyxoviridae Infections; Zoonoses

Condition Hierarchy (Ancestors)

Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Animal Diseases

Study Officials

• Thomas Monath, MD, FASTMH

  Crozet BioPharma

  STUDY DIRECTOR

• Carlos Fierro, MD

  Johnson County Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind for placebo-controlled portion; open label for Booster advance subset; single blind for remaining Booster
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: January 5, 2022
• Study Start: January 10, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: October 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)