Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSV[Delta]G-ZEBOV-GP… (NCT02788227) | Clinical Trial Compass
CompletedPhase 2
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
United States99 participantsStarted 2016-10-14
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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:
✓. 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
What they're measuring
1
Comparison of antibody titer levels between the boosted vs non-boosted groups
Timeframe: Month 36
Trial details
NCT IDNCT02788227
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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