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
- Conditions
- Healthy Volunteers
- Interventions
- Biological: rVSV-Zebov GP vaccine
- Registration Number
- NCT02788227
- Brief 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.
- Detailed Description
Between 1994 and the present, there have been multiple Ebolavirus outbreaks affecting mostly central Africa. However, the 2014/2015 West African outbreak significantly exceeds all previous outbreaks in geographic range, number of individuals affected, and in disruption of typical activities of civil society.
This protocol is a multi-center study to evaluate the durability of the immune response following the open label administration of the rVSVdeltaG-ZEBOV-GP vaccine (V920) as pre-exposure prophylaxis for adults who have an occupational risk for potential exposure to Ebola virus. The vaccine uses a live replicating vesicular stomatitis virus (VSV) replacing the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Zaire strain of Ebola (rVSVdeltaG-ZEBOV-GP also known as V920).
All subjects will receive a single dose of rVSVdeltaG-ZEBOV-GP (\>=7.2 x 10\^7 pfu) on Day 0. We will collect adverse events after vaccination and at Month 1 and Month 19, serious adverse events (SAE) for the duration of the study, and assess the immune response at Months 1, 3, 6, 12, 18, 19, 24, 30, and 36.
A single booster immunization with the same dose of study vaccine as the primary dose (\>=7.2 x 10\^7 pfu/mL) will be given to those randomized at month 18 to the booster arm of the trial. However, if at any time during the observation period antibody levels fall below a predefined seroprotective threshold (yet to be defined in parallel or newly planned studies), a booster will be offered to those who have not previously received a booster injection.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 99
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Boosted Group rVSV-Zebov GP vaccine Group randomized at Month 18 to receive booster vaccination Non-boosted Group rVSV-Zebov GP vaccine Group randomized to 'no booster' at Month 18
- Primary Outcome Measures
Name Time Method Comparison of antibody titer levels between the boosted vs non-boosted groups Month 36 Titer levels in EU/mL
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States