Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSV∆G-ZEBOV-GP Vaccine) (NCT02788227) | Clinical Trial Compass
CompletedPhase 2
Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSV∆G-ZEBOV-GP Vaccine)
United States, Canada248 participantsStarted 2016-10-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults age \>=18 years.
. Signed informed consent for the trial.
. At risk of occupational exposure to Ebola virus through laboratory, clinical contact, or field work, in the judgment of the investigator.
. Females of childbearing potential must be willing to use effective methods of contraception, from at least 30 days prior to vaccination through 1 month following vaccination/booster, which would include:
. All males must be willing to use effective methods of contraception for at least 1 month following vaccination/booster, which would include:
. Willing to minimize blood and body fluid exposure to others for at least 14 days after vaccination/booster. This includes:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Geometric Mean Antibody Titres
Timeframe: Month 36
Trial details
NCT IDNCT02788227
SponsorNational Institutes of Health Clinical Center (CC)
. Agrees not to receive another investigational agent between vaccination and the month 1 study visit (and booster and month 19 study visit).
. Willing to forgo blood donation for one year from vaccination/booster.
Exclusion criteria
. Any condition that would limit the ability of the participant to meet protocol requirements or would place the participant at unreasonable risk. Examples include:
. A process that would adversely affect the systemic immune response
. A process that would require medication that might adversely affect the systemic immune response
. Any contraindication to repeated injections or blood draws
. A condition that requires active medical intervention or monitoring to avert grave danger to the participant's health or well-being during the study period
. A condition or process for which signs or symptoms could be confused with reactions to vaccine