Nipah Virus Infection
Conditions
Keywords
henipavirus, vesicular stomatitis vector, paramyxoviridae infection, zoonotic disease
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
Interventions
BIOLOGICALPHV02
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
OTHERPlacebo
Lactated Ringer's Solution. The placebo will be administered as a single intramuscular injection
Sponsors
Coalition for Epidemic Preparedness Innovations
Public Health Vaccines LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind for placebo-controlled portion; open label for Booster advance subset; single blind for remaining Booster
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by the Toxicity Grading Scale | 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 | 29 days after vaccination | for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials |
Countries
United States
Outcome results
None listed