a phase 1 study to evaluate safety & immunogenicity of rvsv-nipah virus vaccine candidate phv02 in healthy adult subjects

Conditions: Nipah Virus Infection

Summary: a phase 1 study to evaluate the safety and immunogenicity of rvsv-nipah virus vaccine candidate phv02 in healthy adult subjects

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

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

Keywords: henipavirus vesicular stomatitis vector paramyxoviridae infection zoonotic disease