Study to Evaluate Safety and Immunogenicity of a Prime-Boost Regimen of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects

Inclusion criteria

• Healthy, adult, male or non-pregnant, non-lactating females
• Given written informed consent
• No clinically significant health problems
• Negative test for SARS-CoV-2
• Agree to avoid conception through Day 57
• Agree to minimize blood and body fluid exposures to others after vaccination through Day 57
• Agree to avoid exposure to immunocompromised persons after vaccination through Day 57
• Agree to avoid employment in industry involved with livestock after vaccination through Day 57

Exclusion criteria

• Prior infection with Nipah virus, related Henipaviruses or Ebola virus
• Prior infection with vesicular stomatitis virus (VSV)
• Received VSV-vectored vaccine or Ebola vaccine
• BMI < 18.5 or ≥ 35
• 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, 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 investigational product up to 30 days prior to, or planned receipt within 196 days after randomization, or ongoing participation in another interventional clinical trial.
• Receipt of licensed non-live vaccines within 14 days of planned study immunization (30 days for live vaccines) or planned receipt of non-live or live vaccine within 60 days after first study immunization (30 days after the 2nd vaccination).
• 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 (arthrocentesis if indicated by joint effusion), in both cases if acceptable to subject
• Elective surgery planned during the study period