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)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-17

Study Completion Date

2017-09-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Prevention of Ebola Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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V920 Consistency Lot A

Participants received a 1.0 mL intramuscular injection of V920 on Day 1

Group Type EXPERIMENTAL

V920 Consistency Lot A

Intervention Type BIOLOGICAL

V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection

V920 Consistency Lot B

Participants received a 1.0 mL intramuscular injection of V920 on Day 1

Group Type EXPERIMENTAL

V920 Consistency Lot B

Intervention Type BIOLOGICAL

V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot B, live, attenuated, sterile solution for intramuscular injection

V920 Consistency Lot C

Participants received a 1.0 mL intramuscular injection of V920 on Day 1

Group Type EXPERIMENTAL

V920 Consistency Lot C

Intervention Type BIOLOGICAL

V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot C, live, attenuated, sterile solution for intramuscular injection

V920 High-dose Lot

Participants received a 1.0 mL intramuscular injection of V920 on Day 1

Group Type EXPERIMENTAL

V920 High-dose Lot

Intervention Type BIOLOGICAL

V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine high-dose lot, live, attenuated, sterile solution for intramuscular injection

Placebo to V920

Participants received a 1.0 mL intramuscular injection of placebo on Day 1

Group Type PLACEBO_COMPARATOR

Placebo to V920

Intervention Type BIOLOGICAL

Sodium chloride 0.9%, sterile solution for intramuscular injection

Interventions

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V920 Consistency Lot A

V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection

Intervention Type BIOLOGICAL

V920 Consistency Lot B

V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot B, live, attenuated, sterile solution for intramuscular injection

Intervention Type BIOLOGICAL

V920 Consistency Lot C

V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot C, live, attenuated, sterile solution for intramuscular injection

Intervention Type BIOLOGICAL

V920 High-dose Lot

V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine high-dose lot, live, attenuated, sterile solution for intramuscular injection

Intervention Type BIOLOGICAL

Placebo to V920

Sodium chloride 0.9%, sterile solution for intramuscular injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes