MedTrace Logo

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

NCT02788227 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2026-06-17

Study results available
· View outcomes & findings →

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.

Conditions

  • Healthy Volunteers

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.

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • Health Canada

    collaborator OTHER_GOV

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Susan L Moir, Ph.D. · National Institute of Allergy and Infectious Diseases (NIAID)

  • Nadine Rouphael, MD, MSc · The Hope Clinic of the Emory Vaccine Center, Emory University

  • Guillaume Poliquin, MD, FRCPC · Health Canada, 539 John Buhler Research Center, Winnipeg, Canada

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-14
Primary Completion
2025-06-17
Completion
2025-06-17
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02788227 on ClinicalTrials.gov