VSV-ZEBOV Geneva Vaccine Trial

Inclusion Criteria

• Has provided written informed consent before screening
• Adult male or non-pregnant, non-lactating female, ages 18 to 65 (inclusive) at the time of screening
• Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening
• Females of childbearing potential who are willing to use an effective method of contraception, from at least 7 days prior to vaccination through the end of the study period, and a double method from day 0 through day 28
• Males who are willing to use effective contraception from day 0 through day 28:
• Be willing to minimize blood and body fluid exposure of others for 7 days after vaccination
• Use of effective barrier prophylaxis, such as latex condoms, during penetrative sexual intercourse (avoiding the sharing of needles, razors, or toothbrushes, avoiding open-mouth kissing, be willing to refrain from blood donation during the course of the study)

Exclusion Criteria

• Prior receipt of an Ebolavirus or Marburgvirus vaccine, a VSV-vectored vaccine, or any other investigational vaccine likely to impact on interpretation of the trial data
• Serologic evidence of prior Ebola exposure
• Has a household contact (HHC) who is immunodeficient, HIV-positive, pregnant, has an unstable medical condition in the opinion of the investigator (e.g., New York Heart Association Class ≥ II heart failure, severe debilitating asthma and/or chronic obstructive pulmonary disease)
• Works with livestock
• 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 interventional clinical trial
• Receipt of licensed vaccines within 14 days of planned study immunization (30 days for live vaccines) or ongoing participation in another clinical interventional trial
• 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, and/or laboratory screening test
• Any baseline laboratory screening tests which is outside of acceptable range as defined in the protocol: ALT, AST, creatinine, hemoglobin, platelet count, total white blood cell count, urine protein, urine occult blood, urine glucose
• Serologic evidence of hepatitis C infection, evidence of active hepatitis B infection
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, asplenia, cytotoxic therapy in the previous 5 years, and/or diabetes
• Any chronic or active neurologic disorder, including seizures, and epilepsy, excluding febrile seizures as a child
• Has a known history of Guillain-Barré Syndrome
• Has an active malignancy or recent ( 14 days) immunosuppressants or other immune-modifying drugs within 6 months of study entry
• Any other significant finding that, in the opinion of the investigator, would increase the risk of the individual's having an adverse outcome by participating in this study