Placebo Controlled, Dose Response, Safety and Immunogenicity Study of Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-004)
Condition: Ebola Virus
MeSH terms: Hemorrhagic Fever, Ebola
Intervention: V920 Vaccine; Placebo
Intervention description: Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^3, 3x10^4, 3x10^5, 3x10^6, 9x10^6, 2x10^7, or 1x10^8 pfu.; 0.9% Saline
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study comprised two separate cohorts. Cohort 1 consisted of the 4 lower V920 dose groups (3x10^3 pfu, 3x10^4 pfu, 3x10^5 pfu, and 3x10^6 pfu). Cohort 2 consisted of the 3 higher V920 dose groups (9x10^6 pfu, 2x10^7 pfu, 1x10^8 pfu) plus a bridging group that received vaccine at the highest dose evaluated in Cohort 1 (i.e. 3x10^6 pfu). Both Cohorts 1 and 2 had a placebo group.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 513.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus 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 BPSC-1001 to see if it is safe and to see how it affects people's immune system.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy adult male or non-pregnant, non-lactating adult female, ages 18 to 60
             (inclusive) at the time of screening

          2. Have provided written informed consent prior to screening procedures

          3. Free of clinically significant health problems, as determined by pertinent medical
             history, physical examination and clinical judgment of the investigator.

          4. Available, able, and willing to participate for all study visits and procedures.

          5. 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.

          6. Be willing to minimize blood and body fluid exposure of others for 7 days after
             vaccination by:

               1. Using effective barrier prophylaxis, such as latex condoms, during penetrative
                  sexual intercourse

               2. Avoiding the sharing of needles, razors, or toothbrushes

               3. Avoiding open-mouth kissing

          7. 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:

          1. History of prior infection with a filovirus or prior participation in a filovirus
             vaccine trial

          2. History of prior infection with VSV or receipt of a VSV vectored vaccine

          3. Has been involved in the care in any capacity of a patient with Ebola virus infection
             within the previous 21 days

          4. Is a healthcare worker who has direct contact with patients (nurse, physician,
             dentist, emergency medical technician, dental hygienist)

          5. Has a house-hold contact (HHC) who is immunodeficient, on immunosuppressive
             medications, human immunodeficiency virus (HIV)-positive, pregnant, has an unstable
             medical condition

          6. Has an HHC, or is a childcare worker who has direct contact with children, 5 years of
             age or younger

          7. Direct hands-on job preparing food in the food industry

          8. History of employment in an industry involved in contact with ruminant animals,
             veterinary sciences, or other potential exposure to VSV

          9. History of employment or activity which involves potential contact with filoviruses

         10. History of severe local or systemic reactions to any vaccination or a history of
             severe allergic reactions

         11. Known allergy to the components of the BPSC1001 vaccine product

         12. Receipt of investigational product up to 30 days prior to randomization or ongoing
             participation in another clinical trial

         13. Receipt of licensed non-live vaccines within 14 days of planned study immunization (30
             days for live vaccines)

         14. 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

         15. 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.

         16. Any baseline laboratory screening test which in the opinion of the investigator, is
             considered clinically significant

         17. Any serologic evidence of hepatitis B or C infection

         18. Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             HIV-1, HIV-2 infection, cytotoxic therapy in the previous 5 years, and/or diabetes

         19. Any chronic or active neurologic disorder, including migraines, seizures, and
             epilepsy, excluding a single febrile seizure as a child

         20. Have a known history of Guillain-Barré Syndrome

         21. Have an active malignancy or history of metastatic or hematologic malignancy

         22. Suspected or known alcohol and/or illicit drug abuse within the past 5 years

         23. Moderate or severe illness and/or fever >100.4°F within 1 week prior to vaccination
             (can be rescheduled)

         24. Pregnant or lactating female, or female who intends to become pregnant during the
             study period

         25. Administration of IgGs and/or any blood products within the 120 days preceding study
             entry or planned administration during the study period

         26. History of blood donation within 60 days of enrollment or plans to donate within the
             study period

         27. Administration of chronic (defined as more than 14 days) immunosuppressants or other
             immune modifying drugs within 6 months of study entry

               1. For corticosteroids, this includes prednisone, or equivalent, greater than or
                  equal to 0.5 mg/kg/day

               2. Intranasal, topical, and intra-articular steroids are allowed

         28. Unwilling to allow storage and use of blood for future vaccine research

        28. Research staff or the immediate family of research staff directly involved with the
        clinical study.

        29. Unwilling to undergo diagnostic evaluation of joint signs and symptoms, which may
        include arthrocentesis if clinically indicated based on presence of effusion and if the
        procedure is acceptable to the subject at the time (Cohort 2 only) 30. Unwilling to undergo
        diagnostic evaluation of skin rash, to include punch biopsy if clinically indicated and if
        the procedure is acceptable to the subject at the time (Cohort 2 only) 31. Research staff
        or the immediate family of research staff directly involved in the clinical study 32. 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 33. Elective
        surgery or hospitalization planned during the period of study participation 34. Has
        traveled to an area where the World Health Organization has declared as an Ebola outbreak
        zone 35. History of chronic inflammatory disease (e.g., rheumatoid arthritis, psoriatic
        arthritis, reactive arthritis, ankylosing spondylitis, systemic lupus erythematosus,
        psoriasis, Crohn's disease, ulcerative colitis, and gout), symptomatic osteoarthritis, or
        any other autoimmune or autoinflammatory disorder