Search / Trial NCT06221813

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

Launched by PUBLIC HEALTH VACCINES LLC · Jan 15, 2024

Trial Information

Current as of October 03, 2024

Recruiting

Keywords

Live, Attenuated Vaccine Nipah Virus Phv02 Recombinant Vesicular Stomatitis Virus

Description

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * 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
  • Exclusion Criteria:
  • * 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

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Hollywood, Florida, United States

Anaheim, California, United States

Salt Lake City, Utah, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0