Clinical trial NCT05178901: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nipah Virus Infection
Keywords: henipavirus
vesicular stomatitis vector
paramyxoviridae infection
zoonotic disease
Lead sponsor: Public Health Vaccines LLC
Sponsor class: INDUSTRY
Collaborators: name: Coalition for Epidemic Preparedness Innovations
First posted: 2022-01-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by the Toxicity Grading Scale
timeFrame: 42 days after vaccination
measure: Number of participants with Nipah-specific antibody and neutralizing antibody responses as assessed by ELISA
timeFrame: 29 days after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Johnson County Clin-Trials(JCCT)
state: Kansas
Study officials:
affiliation: Crozet BioPharma
name: Thomas Monath, MD, FASTMH
role: STUDY_DIRECTOR
affiliation: Johnson County Clinical Trials
name: Carlos Fierro, MD
role: PRINCIPAL_INVESTIGATOR
References: