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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05178901
Recruitment Status : Completed
First Posted : January 5, 2022
Last Update Posted : January 31, 2024
Sponsor:
Collaborator:
Coalition for Epidemic Preparedness Innovations
Information provided by (Responsible Party):
Public Health Vaccines LLC

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

Condition or disease Intervention/treatment Phase
Nipah Virus Infection Biological: PHV02 Other: Placebo Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind for placebo-controlled portion; open label for Booster advance subset; single blind for remaining Booster
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : January 10, 2022
Actual Primary Completion Date : May 30, 2023
Actual Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
Placebo Comparator: Placebo Other: Placebo
Lactated Ringer's Solution. The placebo will be 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


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by the Toxicity Grading Scale [ Time Frame: 42 days after vaccination ]
    for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials

  2. Number of participants with Nipah-specific antibody and neutralizing antibody responses as assessed by ELISA [ Time Frame: 29 days after vaccination ]
    for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05178901


Locations
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United States, Kansas
Johnson County Clin-Trials(JCCT)
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Public Health Vaccines LLC
Coalition for Epidemic Preparedness Innovations
Investigators
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Study Director: Thomas Monath, MD, FASTMH Crozet BioPharma
Principal Investigator: Carlos Fierro, MD Johnson County Clinical Trials
More Information
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Responsible Party: Public Health Vaccines LLC
ClinicalTrials.gov Identifier: NCT05178901    
Other Study ID Numbers: PHV02-C-101
First Posted: January 5, 2022    Key Record Dates
Last Update Posted: January 31, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Public Health Vaccines LLC:
henipavirus
vesicular stomatitis vector
paramyxoviridae infection
zoonotic disease
Additional relevant MeSH terms:
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Henipavirus Infections
Infections
Virus Diseases
 Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections