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

Study Overview
=================
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

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

Conditions
-----------------
Nipah Virus Infection

Intervention / Treatment
-----------------
* Biological: PHV02
* Other: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PHV02 2x10^5 pfu<br> | Biological: PHV02<br>* 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<br>|
| Experimental: PHV02 2x10^6 pfu<br> | Biological: PHV02<br>* 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<br>|
| Experimental: PHV02 2x10^7 pfu<br> | Biological: PHV02<br>* 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<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Lactated Ringer's Solution. The placebo will be administered as a single intramuscular injection<br>|
| Experimental: PHV02 5x10^8 pfu (Boost)<br> | Biological: PHV02<br>* 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<br>|
| Experimental: PHV02 5x10^8 pfu (Prime)<br> | Biological: PHV02<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by the Toxicity Grading Scale | for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials | 42 days after vaccination | 
| Number of participants with Nipah-specific antibody and neutralizing antibody responses as assessed by ELISA | for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials | 29 days after vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
henipavirus, vesicular stomatitis vector, paramyxoviridae infection, zoonotic disease