Safety and Immunogenicity of Prime-Boost Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-002)
Condition: Ebola Viruses
MeSH terms: Hemorrhagic Fever, Ebola
Intervention: Placebo; V920
Intervention description: Normal saline placebo.; Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^6, 2x10^7, or 1x10^8 pfu.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Ebola virus has infected and killed people, mostly in Africa. In 2014, the Zaire ebolavirus
      (ZEBOV) has affected several thousand people. There is no approved effective way to treat or
      prevent Ebola. Researchers are trying to develop a vaccine for it. This is a study of the
      anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (V920; BPSC-1001) to see if it is
      safe and to see how it affects people's immune system.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Healthy male or females, ages 18 to 65 (inclusive) at the time of screening

          -  Females of childbearing potential and all males, must be willing to use effective
             methods of contraception, from at least 14 days prior to vaccination through Day 56
             which would include:

               -  Oral contraceptives, either combined or progestogen alone

               -  injectable progestogen

               -  implants of etonogestrel or levonorgestrel

               -  oestrogenic vaginal ring

               -  percutaneous contraceptive patches

               -  intrauterine device or intrauterine system

               -  male partner sterilization

               -  male condom combined with a spermicide

          -  Must be willing to minimize blood and body fluid exposure of others for at least 7
             days after vaccination, which includes:

               -  Use of effective barrier prophylaxis, such as latex condoms, during any sexual
                  interaction (regardless of childbearing status or sexual orientation)

               -  Avoiding the sharing of needles, razors, eating utensils, drinking from the same
                  cup, or toothbrushes

               -  Avoiding open-mouth kissing

          -  Must be willing to forgo blood donation for one year

          -  Must agree not to enroll in another study of an investigational agent prior to
             completion of Day 56 and not participate in an investigational vaccine study until the
             last required protocol visit on Day 365

          -  Ability to provide informed consent

        EXCLUSION CRITERIA:

        FACTORS THAT INCREASE RISK TO THE SUBJECT:

          -  Clinically significant medical condition, physical examination findings, clinically
             significant abnormal laboratory results, or past medical history with clinically
             significant implications for current health. A clinically significant condition or
             process includes but is not limited to:

               -  A process that would affect the immune response

               -  A process that would require medication that affects the immune response

               -  Any contraindication to repeated injections or blood draws

               -  A condition that requires active medical intervention or monitoring to avert
                  grave danger to the participant's health or well-being during the study period

               -  A condition or process for which signs or symptoms could be confused with
                  reactions to vaccine

               -  Any condition specifically listed among the exclusion criteria below

               -  Active malignancy

               -  Asplenia

               -  History of Guillain-Barré Syndrome

               -  History of neurological or neuropsychiatric disorder that may either increase
                  risk (history of encephalitis, narcolepsy, stroke, depression, bipolar disorder,
                  seizure, etc.) or could interfere with the assessment of safety (e.g., frequent
                  headaches)

               -  History of autoimmune disease

               -  History of hemoglobinopathy or a coagulopathy

          -  Women who are breast-feeding

          -  Positive urine or serum pregnancy test

          -  Abnormal chemistry panel; defined as:

               -  Defined as any Grade 3 or greater toxicity (regardless of clinical significance)
                  by the toxicity table

               -  Evaluating only creatinine, alanine aminotransferase, aspartate aminotransferase,
                  total bilirubin, and estimated glomerular filtration rate

          -  Abnormal complete blood count (CBC) defined as:

               -  Defined as any Grade 3 or greater toxicity (regardless of clinical significance)
                  by the toxicity table

               -  Evaluating only the white blood cell (WBC), hemoglobin, hematocrit, and platelets

          -  Abnormal urinalysis defined as:

               -  Defined as any Grade 3 or greater toxicity (regardless of clinical significance)
                  by the toxicity table

               -  Evaluating red blood cells (RBC), protein, and glucose only

          -  Positive serology for hepatitis B surface antigen

          -  Positive serology for hepatitis C

          -  Positive serology for human immunodeficiency virus (HIV)

          -  Known allergy to the components of the VSVΔG-ZEBOV vaccine (V920) vaccine product
             (VSV, albumin, tris)

          -  History of severe local or systemic reactions to any vaccination or a history of
             severe allergic reactions

        FACTORS THAT MAY LIMIT VSV REPLICATION OR MAKE INTERPRETATION OF IMMUNOGENICITY DIFFICULT:

          -  History of prior infection with a filovirus or prior participation in a filovirus
             vaccine trial

          -  Veterinarian or ranchers exposed to livestock known to be infected with VSV

          -  History of prior infection with VSV or receipt of a VSV vectored vaccine

        FACTORS THAT WOULD INCREASE RISK TO OTHERS DUE TO VSV VIRAL SHEDDING:

          -  Is a healthcare worker who will have direct contact with patients within 14 days of
             each vaccination

          -  Is an animal care worker, who will have direct contact with animals (livestock or
             domestic, besides subjects family pet) within 14 days of each vaccination

          -  Has a house-hold contact (HHC) who is immunodeficient (in the opinion of the
             investigator), pregnant, has an unstable medical condition, or is under the age of 5
             years

          -  Is a childcare worker who has direct contact with children 5 years of age or younger

        FACTORS THAT COULD IMPAIR INTERPRETATION OR EXECUTION OF THE STUDY:

          -  Receipt of any investigational drug within 5 half-lives or 30 days, whichever is
             longer, prior to study drug administration (i.e., Day 0)

          -  Receipt of licensed vaccines 14 days before the planned study immunization

          -  Receipt of immunoglobulins and/or any blood products within the 120 days preceding
             study entry or that are planned during the study period

          -  Immunosuppressive medications received within 168 days before first vaccination. (Not
             including: [1] corticosteroid nasal spray for allergic rhinitis; [2] topical
             corticosteroids for mild, uncomplicated dermatitis; or [3] oral/parenteral
             corticosteroids given for non-chronic conditions not expected to recur [length of
             therapy 10 days or less with completion at least 30 days prior to vaccination(s)].)

          -  Allergy treatment with antigen injections within 30 days before first vaccination or
             that are scheduled through Day 56

          -  Participants who, in the judgment of the investigator, will be unlikely to comply with
             the requirements of this protocol