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Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSV[Delta]G-ZEBOV-GP) for Pre-Exposure Prophylaxis (PREP) in People at Potential Occupational Risk for Ebola Virus Exposure

NCT02788227 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2025-07-01

No results posted yet for this study

Summary

Background:

The Ebola virus causes a severe disease. It can be fatal. The usual incubation period after being exposed is 2 to 21 days. There is no approved treatment for Ebola infection. There is also no vaccine to prevent infection either before or after exposure. Researchers want to test an Ebola vaccine. They want to give it to people before they are exposed to the virus in order to prevent the disease.

Objectives:

To see how long-lasting and effective the vaccine rVSV\[delta\]G -ZEBOV-GP (V920) is at preventing Ebola.

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-Zebov GP vaccine

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

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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