Placebo Controlled, Dose Response, Safety and Immunogenicity Study of Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-004)

Inclusion Criteria

• Healthy adult male or non-pregnant, non-lactating adult female, ages 18 to 60 (inclusive) at the time of screening
• Have provided written informed consent prior to screening procedures
• Free of clinically significant health problems, as determined by pertinent medical history, physical examination and clinical judgment of the investigator.
• Available, able, and willing to participate for all study visits and procedures.
• Males and females who are willing to practice abstinence from sexual intercourse with the opposite sex, 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 by:
• Using effective barrier prophylaxis, such as latex condoms, during penetrative sexual intercourse
• Avoiding the sharing of needles, razors, or toothbrushes
• Avoiding open-mouth kissing
• Resides in the geographic area of a clinical study site for 1 year after vaccination without risk of deployment outside the U.S.

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
• Has been involved in the care in any capacity of a patient with Ebola virus infection within the previous 21 days
• Is a healthcare worker who has direct contact with patients (nurse, physician, dentist, emergency medical technician, dental hygienist)
• Has a house-hold contact (HHC) who is immunodeficient, on immunosuppressive medications, human immunodeficiency virus (HIV)-positive, pregnant, has an unstable medical condition
• Has an HHC, or is a childcare worker who has direct contact with children, 5 years of age or younger
• Direct hands-on job preparing 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
• 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 randomization or ongoing participation in another clinical trial
• Receipt of licensed non-live vaccines within 14 days of planned study immunization (30 days for live vaccines)
• 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 examination, and/or laboratory screening test. This would include a known hemoglobinopathy or coagulation abnormality.
• Any baseline laboratory screening test which in the opinion of the investigator, is considered clinically significant
• Any serologic evidence of hepatitis B or C infection
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV-1, HIV-2 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 a known history of Guillain-Barré Syndrome
• 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 >100.4°F within 1 week prior to vaccination (can be rescheduled)
• Pregnant or lactating female, or female who intends to become pregnant during the study period
• Adm