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

NCT06221813
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Phase
Phase 1
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Recruitment status
Completed
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Participants
120
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Lead sponsor
Public Health Vaccines LLC
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Start date
2024-01-26
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Number of sites
3
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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.
clinicaltrials.gov
Short title
Study to Evaluate Safety and Immunogenicity of a Prime-Boost Regimen of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
clinicaltrials.gov
Official title
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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2024-10-02
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First posted
2024-01-24
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Registry last updated
2025-06-08
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Primary completion date
2024-09-30
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Start date
2024-01-26
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Actual participants
120
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Participants
120
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Participant count basis
Actual
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Protocol amendments
4
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Number of sites
3
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Public Health Vaccines LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06221813
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ClinicalTrials.gov ID
NCT06221813
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: 14 days after each dose

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

    Timeframe: 28 days after each dose

  3. Percentage of participants with neurologic AEs

    Timeframe: Study Days 1-57

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

    Timeframe: From time of injection through final study visit (Day 197)

  5. Proportion of participants with recombinant vesicular stomatitis virus (rVSV) RNA (Cohort 1 only) in plasma, urine and saliva

    Timeframe: From time of injection through Day 43

  6. Proportion of participants who seroconvert compared to Day 1

    Timeframe: Day 29 and Day 57

  7. Geometric mean titers of IgG and ELISA neutralizing antibodies

    Timeframe: Day 1, 29, 57

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
59 Years
Healthy volunteers
Yes

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Cenexel ACT (Anaheim Clinical Trials)Anaheim, United States
  • Cenexel RCA (Research Centers of America)Hollywood, United States
  • Cenexel JBR (JBR Clinical Research)Salt Lake City, United States
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (3)

Collaborators (1)

Lead sponsors (1)

Conditions (1)