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

• ClinicalTrials.gov Identifier: NCT05178901
• Recruitment Status: Completed
• First Posted: January 5, 2022
• Last Update Posted: January 31, 2024
• Sponsor: Public Health Vaccines LLC
• Collaborator: Coalition for Epidemic Preparedness Innovations
• Information provided by (Responsible Party): Public Health Vaccines LLC

Tracking Information

• First Submitted Date: December 6, 2021
• First Posted Date: January 5, 2022
• Last Update Posted Date: January 31, 2024
• Actual Study Start Date: January 10, 2022
• Actual Primary Completion Date: May 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 10, 2023)

• 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
• 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

Original Primary Outcome Measures (submitted: January 4, 2022)

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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Study Design

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

• Condition: Nipah Virus Infection

Intervention

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

Study Arms

• Experimental: PHV02 2x10^5 pfu
  Intervention: Biological: PHV02
• Experimental: PHV02 2x10^6 pfu
  Intervention: Biological: PHV02
• Experimental: PHV02 2x10^7 pfu
  Intervention: Biological: PHV02
• Placebo Comparator: Placebo
  Intervention: Other: Placebo
• Experimental: PHV02 5x10^8 pfu (Boost)
  Intervention: Biological: PHV02
• Experimental: PHV02 5x10^8 pfu (Prime)
  Intervention: Biological: PHV02

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 4, 2022): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 30, 2023
• Actual Primary Completion Date: May 30, 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05178901
• Other Study ID Numbers: PHV02-C-101
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Public Health Vaccines LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Public Health Vaccines LLC
• Original Study Sponsor: Same as current
• Collaborators: Coalition for Epidemic Preparedness Innovations

Investigators

• Study Director: Thomas Monath, MD, FASTMH; Crozet BioPharma
• Principal Investigator: Carlos Fierro, MD; Johnson County Clinical Trials

• PRS Account: Public Health Vaccines LLC
• Verification Date: January 2024