Phase
Condition
N/ATreatment
Lactated Ringer's
PHV02
Clinical Study ID
Ages 18-59 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 throughDay 57
Agree to avoid exposure to immunocompromised persons after vaccination through Day 57
Agree to avoid employment in industry involved with livestock after vaccinationthrough Day 57
Exclusion
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 interventionalclinical 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 60days 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) orjoint symptoms (arthrocentesis if indicated by joint effusion), in both cases ifacceptable to subject
Elective surgery planned during the study period
Study Design
Connect with a study center
Cenexel ACT (Anaheim Clinical Trials)
Anaheim, California 92801
United StatesSite Not Available
Cenexel RCA (Research Centers of America)
Hollywood, Florida 33024
United StatesSite Not Available
Cenexel JBR (JBR Clinical Research)
Salt Lake City, Utah 84107
United StatesSite Not Available
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