Vaccine Treatment for Ebola Virus in Healthy Adults (V920-001)
Condition: Ebola Virus
MeSH terms: Hemorrhagic Fever, Ebola
Intervention: V920; Placebo
Intervention description: Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^6, 2x10^7, or 1x10^8 pfu.; Normal saline placebo.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study of the anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (Zaire
      ebolavirus) also known as V920 and BPSC-1001. The purpose of this study is to test how safe
      the vaccine is in humans and how well it makes the human immune system cause an immune- or
      defense-response to Ebola virus. This vaccine will be studied at different doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult male or non-pregnant, non-lactating female, ages 18 to 50 (inclusive) at
             the time of screening

          -  Have provided written informed consent before screening

          -  Free of clinically significant health problems, as determined by pertinent medical
             history and clinical examination prior to entry into the study

          -  Available, able, and willing to participate for all study visits and procedures

          -  Males and females who are willing to practice abstinence from sexual intercourse, or
             willing to use effective methods of contraception, from at least 30 days prior to
             vaccination until study end.

          -  Be willing to minimize blood and body fluid exposure of others for 7 days after
             vaccination

          -  Score at least 80% on the Comprehension Assessment test

        Exclusion Criteria:

          -  History of prior infection with a filovirus or prior participation in a filovirus
             vaccine trial

          -  History of prior infection with VSV or receipt of a VSV vectored vaccine

          -  Is a healthcare worker who has direct contact with patients

          -  Has a house-hold contact (HHC) who is immunodeficient, Human Immunodeficiency Virus
             (HIV)-positive, 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

          -  Directly prepares food in the food industry

          -  History of employment in an industry involved in contact with ruminant animals,
             veterinary sciences, or other potential exposure to VSV

          -  Planned or frequent contact with animals at-risk of VSV infection (e.g. cattle,
             horses, pigs, mules, etc.)

          -  History of employment or activity which involves potential contact with filoviruses

          -  History of severe local or systemic reactions to any vaccination or a history of
             severe allergic reactions

          -  Known allergy to the components of the BPSC1001 vaccine product

          -  Receipt of investigational product up to 30 days prior to enrollment or ongoing
             participation in another clinical trial

          -  Receipt of licensed vaccines within 30 days of planned study immunization

          -  Ongoing participation in another clinical trial

          -  Ability to observe possible local reactions at the eligible injections sites (deltoid
             region) is, in the opinion of the investigator, unacceptably obscured due to a
             physical condition or permanent body art

          -  Acute or chronic, clinically significant psychiatric, hematologic, pulmonary,
             cardiovascular, or hepatic or renal functional abnormality as determined by the
             investigator based on medical history, physical exam, electrocardiogram, and/or
             laboratory screening test. This would include a known hemoglobinopathy or coagulation
             abnormality.

          -  Any baseline laboratory screening tests which is outside of acceptable range as
             defined in the protocol.: alanine aminotransferase, aspartate aminotransferase,
             creatinine, hemoglobin, platelet count, total white blood cell count, urine protein,
             urine occult blood, urine glucose

          -  Any serologic evidence of hepatitis B or C infection

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             HIV infection, cytotoxic therapy in the previous 5 years, and/or diabetes

          -  Any chronic or active neurologic disorder, including migraines, seizures, and
             epilepsy, excluding a single febrile seizure as a child

          -  Have an active malignancy or history of metastatic or hematologic malignancy

          -  Suspected or known alcohol and/or illicit drug abuse within the past 5 years

          -  Moderate or severe illness and/or fever >100.4F within one week prior to vaccination

          -  Pregnant or lactating female, or female who intends to become pregnant during the
             study period

          -  Administration of immunoglobulins and/or any blood products within the 120 days
             preceding study entry or planned administration during the study period

          -  History of blood donation within 60 days of enrollment or plans to donate within the
             study period

          -  Administration of chronic (defined as more than 14 days) immunosuppressants or other
             immune modifying drugs within 6 months of study entry. (For corticosteroids, this will
             mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day, Intranasal and
             topical steroids are allowed)

          -  Unwilling to allow storage and use of blood for future vaccine research

          -  Any other significant finding that in the opinion of the investigator would increase
             the risk of the individual having an adverse outcome from participating in this study