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

Public Health Vaccines

Status and phase: Completed; Phase 1

Conditions: Nipah Virus Infection

Treatments: Other: Placebo; Biological: PHV02

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05178901

PHV02-C-101

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 6 patient groups, including a placebo group

PHV02 2x10^5 pfu

Experimental group

Treatment:

Biological: PHV02

PHV02 2x10^6 pfu

Experimental group

Treatment:

Biological: PHV02

PHV02 2x10^7 pfu

Experimental group

Treatment:

Biological: PHV02

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

PHV02 5x10^8 pfu (Boost)

Experimental group

Treatment:

Biological: PHV02

PHV02 5x10^8 pfu (Prime)

Experimental group

Treatment:

Biological: PHV02