Evaluation of the Safety and Immunogenicity of Three Consistency Lots and a High-Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults (V920-012)
Condition: Prevention of Ebola Infection
MeSH terms: Hemorrhagic Fever, Ebola
Intervention: V920 Consistency Lot A; V920 Consistency Lot B; V920 Consistency Lot C; V920 High-dose Lot; Placebo to V920
Intervention description: V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection; V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot B, live, attenuated, sterile solution for intramuscular injection; V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot C, live, attenuated, sterile solution for intramuscular injection; V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine high-dose lot, live, attenuated, sterile solution for intramuscular injection; Sodium chloride 0.9%, sterile solution for intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1197.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study evaluated the safety and immunogenicity of 3 consistency lots and a high-dose lot
      of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this study
      was to demonstrate consistency in the immune responses of participants receiving 3 separate
      lots of V920 through 28 days postvaccination. In addition to the 3 lot groups, a high-dose
      group and a placebo group were studied. A subset of participants representative of all
      treatment groups continued through 24 months postvaccination in the extension study for the
      evaluation of long-term safety. The primary hypothesis states that the geometric mean titer
      of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibody at 28 days postvaccination is
      equivalent across the three consistency lots.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Not of reproductive potential, or of reproductive potential and agrees to avoid
             becoming pregnant or impregnating a partner for 2 months following study vaccination.

        Exclusion Criteria:

          -  Is currently participating in or has participated in an interventional clinical trial
             with an investigational compound or device within 90 days of participation in this
             trial.

          -  Has previously been randomized in another clinical trial and received V920 or any
             other Ebola vaccine.

          -  Has been exposed to Ebola virus at any time prior to study entry.

          -  Is pregnant or breastfeeding or plans to conceive within 2 months following study
             vaccination.

          -  Has direct household exposure to a pregnant or lactating woman at the time of
             participation in this trial.

          -  Has had a fever (≥100.5ºF/38.0ºC) within 48 hours prior to study entry.

          -  Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of
             prednisone or ≥20 mg/day for persons weighing >10 kg) for ≥14 consecutive days and has
             not completed treatment at least 30 days prior to study entry.

          -  Has received systemic corticosteroids exceeding physiologic replacement doses (~5
             mg/day prednisone equivalent) within 14 days prior to study entry.

          -  Has received any live virus vaccine within 30 days prior to study entry or any other
             (nonlive virus) vaccine within 14 days prior to study entry.

          -  Has known or suspected impairment of immunological function (e.g., HIV positive).

          -  Has direct household exposure to a person with known or suspected impairment of
             immunological function (e.g., HIV positive).

          -  Has a clinically significant history of intravenous (IV) drug abuse within 12 months
             prior to study entry.

          -  Has a known allergy/sensitivity or contraindication to investigational product(s) or
             its/their excipients (e.g., albumin).

          -  Has a history of malignancy <=5 years prior to study entry except for adequately
             treated basal cell or squamous cell skin cancer or in situ cervical cancer.

          -  Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or
             child) who is investigational site or sponsor staff directly involved with this trial.