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COMPLETED
NCT02788227
PHASE2

Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSV∆G-ZEBOV-GP Vaccine)

Sponsor: National Institutes of Health Clinical Center (CC)

View on ClinicalTrials.gov

Summary

Background: The Ebola virus causes a severe disease that can be fatal. The usual incubation period to illness after being exposed is 2 to 21 days. There are only limited treatments currently available for Ebola infection. A vaccine to prevent infection either before or after exposure was approved in 2020 but the durability of the vaccine response is unknown. Researchers wish to study the potential to increase the antibody response to the licensed Ebola vaccine. An improved response before exposure to the virus potentially could increase the vaccine's effectiveness in preventing disease. Objectives: To see if the antibody response to the vaccine, rVSV∆G-ZEBOV-GP vaccine (V920), could potentially be improved by providing a booster injection several months after the primary immunization. Eligibility: Healthy adults at risk of exposure to the Ebola virus at work through lab or clinical contact. Design: * Participants will be screened with medical history, physical exam, and blood tests. * Participants will get the study vaccine. It will be injected into their upper arm. * Participants will be monitored closely for at least 30 minutes. They will get a diary card to record any symptoms they have from the vaccine for up to 14 days. * Participants will have study visits at 1, 3, and 6 months after they get the vaccine, then every 6 months (that is, at months 12, 18, 19, 24, 30, and 36 of study) for a total of 36 months. * Eighteen months after they join the study, participants will be randomly assigned to one of two groups. One group will get a second (or booster) dose of the vaccine. The other group will not get a second dose. * This study lasts 36 months. In December 2024, the study was approved to re-enroll up to 30 participants from the primary cohort to check longer-term immune response to the study vaccine beyond 36 months.

Official title: A Multicenter Study of the Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSV∆G-ZEBOV-GP Vaccine) for Pre-Exposure Prophylaxis in Individuals at Potential Occupational Risk for Ebola Virus Exposure (PREPARE)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

248

Start Date

2016-10-14

Completion Date

2025-06-17

Last Updated

2026-06-17

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

rVSV∆G-ZEBOV-GP Vaccine (V920)

Primary vaccination for all participants, one-to-one randomization at Month 18 to receive booster vaccination or no booster.

Locations (3)

The Hope Clinic of the Emory Vaccine Center, Emory University

Decatur, Georgia, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Health Canada, 539 John Buhler Research Center

Winnipeg, Manitoba, Canada