NCT06221813

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

January 26, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2024

Completed
Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

January 15, 2024

Last Update Submit

June 4, 2025

Conditions

Nipah Virus Infection

Keywords

live, attenuated vaccineNipah virusPHV02recombinant vesicular stomatitis virus

Outcome Measures

Primary Outcomes (7)

  • Percentage of participants with local injection site and systemic adverse events (AEs)

    14 days after each dose

  • Percentage of participants with joint related symptoms, rash and unsolicited AEs

    28 days after each dose

  • Percentage of participants with neurologic AEs

    Study Days 1-57

  • Percentage of participants with medically-attended AEs (MAAEs) and serious AEs (SAEs)

    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

    From time of injection through Day 43

  • Proportion of participants who seroconvert compared to Day 1

    Day 29 and Day 57

  • Geometric mean titers of IgG and ELISA neutralizing antibodies

    Day 1, 29, 57

Study Arms (8)

Cohort 1 (first 60 subjects) PHV02 high dose

EXPERIMENTAL
Biological: PHV02

Cohort 1 (first 60 subjects) PHV02 medium dose

EXPERIMENTAL
Biological: PHV02

Cohort 1 (first 60 subjects) PHV02 low dose

EXPERIMENTAL
Biological: PHV02

Cohort 1 (first 60 subjects) Placebo

PLACEBO COMPARATOR
Biological: Lactated Ringer's

Cohort 2 (next 60 subjects) PHV02 high dose

EXPERIMENTAL
Biological: PHV02

Cohort 2 (next 60 subjects) PHV02 medium dose

EXPERIMENTAL
Biological: PHV02

Cohort 2 (next 60 subjects) PHV02 low dose

EXPERIMENTAL
Biological: PHV02

Cohort 2 (next 60 subjects) Placebo

PLACEBO COMPARATOR
Biological: Lactated Ringer's

Interventions

PHV02BIOLOGICAL

Nipah virus vaccine

Cohort 1 (first 60 subjects) PHV02 high doseCohort 1 (first 60 subjects) PHV02 low doseCohort 1 (first 60 subjects) PHV02 medium doseCohort 2 (next 60 subjects) PHV02 high doseCohort 2 (next 60 subjects) PHV02 low doseCohort 2 (next 60 subjects) PHV02 medium dose
Lactated Ringer'sBIOLOGICAL

Placebo

Cohort 1 (first 60 subjects) PlaceboCohort 2 (next 60 subjects) Placebo

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cenexel ACT (Anaheim Clinical Trials)

Anaheim, California, 92801, United States

Location

Cenexel RCA (Research Centers of America)

Hollywood, Florida, 33024, United States

Location

Cenexel JBR (JBR Clinical Research)

Salt Lake City, Utah, 84107, United States

Location

Related Publications (1)

  • Monath TP, Nichols R, Feldmann F, Griffin A, Haddock E, Callison J, Meade-White K, Okumura A, Lovaglio J, Hanley PW, Clancy CS, Shaia C, Rida W, Fusco J. Immunological correlates of protection afforded by PHV02 live, attenuated recombinant vesicular stomatitis virus vector vaccine against Nipah virus disease. Front Immunol. 2023 Sep 4;14:1216225. doi: 10.3389/fimmu.2023.1216225. eCollection 2023.

    PMID: 37731485BACKGROUND

MeSH Terms

Conditions

Henipavirus Infections

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Paramyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Joan Fusco, PhD

    Public Health Vaccines

    STUDY CHAIR

  • Thomas P Monath, MD

    Quigley Biopharma

    STUDY DIRECTOR

  • Gray P Heppner, MD

    Quigley Biopharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2024

First Posted

January 24, 2024

Study Start

January 26, 2024

Primary Completion

September 30, 2024

Study Completion

October 2, 2024

Last Updated

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(3)