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)

A Phase III, Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Immunogenicity of Three Consistency Lots and a High Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults

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.

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.