Overview

This trial is active, not recruiting.

Condition prevention of ebola infection
Treatments v920 consistency lot a, v920 consistency lot b, v920 consistency lot c, v920 high-dose lot, placebo to v920
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date August 2015
End date May 2016
Trial size 1198 participants
Trial identifier NCT02503202, 2015-001658-14, V920-012

Summary

The study will evaluate 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 is to demonstrate consistency in the immune responses of participants receiving 3 separate lots of V920 (at release dose) through 28 days postvaccination. A subset of participants representative of all treatment groups will continue through 24 months postvaccination in the extension study for the evaluation of safety, and durability of immune response. Safety of the vaccines and matching placebo will be evaluated through 6 months postvaccination for all participants and through 24 months postvaccination for participants continuing in the study extension.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Single 1.0 mL intramuscular injection on Day 1
v920 consistency lot a
V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection
(Experimental)
Single 1.0 mL intramuscular injection on Day 1
v920 consistency lot b
V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot B, live, attenuated, sterile solution for intramuscular injection
(Experimental)
Single 1.0 mL intramuscular injection on Day 1
v920 consistency lot c
V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot C, live, attenuated, sterile solution for intramuscular injection
(Experimental)
Single 1.0 mL intramuscular injection on Day 1
v920 high-dose lot
V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine high-dose lot, live, attenuated, sterile solution for intramuscular injection
(Placebo Comparator)
Single 1.0 mL intramuscular injection on Day 1
placebo to v920
Sodium chloride 0.9%, sterile solution for intramuscular injection

Primary Outcomes

Measure
Geometric Mean Titer of anti-ZEBOV Glycoprotein Antibody
time frame: Day 28 postvaccination

Secondary Outcomes

Measure
Percentage of Participants Reporting Serious Adverse Experiences
time frame: Up to Month 6 postvaccination
Percentage of Participants with Vaccine Report Card (VRC)-prompted Injection-site Adverse Events
time frame: Up to Day 5 postvaccination
Percentage of Participants with VRC-prompted Elevated Temperature
time frame: Up to Day 42 postvaccination
Percentage of Participants with Arthralgia/Arthritis
time frame: Up to Month 6 postvaccination
Percentage of Participants with Petechial/purpuric Rash
time frame: Up to Month 6 postvaccination
Percentage of Participants with Vesicular Lesions
time frame: Up to Month 6 postvaccination

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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 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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..