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
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|ClinicalTrials.gov Identifier: NCT02788227|
Recruitment Status : Enrolling by invitation
First Posted : June 2, 2016
Last Update Posted : July 6, 2018
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.
To see how long-lasting and effective the vaccine rVSV[delta]G ZEBOV-GP (V920) is at preventing Ebola.
Healthy adults at risk of exposure to the Ebola virus at work through lab or clinical contact.
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: rVSVdeltaG-ZEBOV GP (2X 107 pfu/mL)||Phase 2|
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 investigational 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 (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 (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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Study of the Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSVdeltaG-ZEBOV GP) for Pre-Exposure Prophylaxis in Individuals at Potential Occupational Risk for Ebola Virus Exposure (PREPARE)|
|Study Start Date :||January 12, 2016|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||October 21, 2022|
Open label vaccine arm with booster.
Drug: rVSVdeltaG-ZEBOV GP (2X 107 pfu/mL)
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 asV920).
- Evaluate the durability of the immune response to rVSVdeltaG-ZEBOV GP vaccine (V920) over 3 years, in the setting of pre-exposure prophylaxis. [ Time Frame: months 1,3,6 after vaccination, then every six months for a total of 36 months of study ]
- Exploratory: Determine the immune response to a booster immunization, if given, following primary vaccination with the rVCVdeltaG-ZEBOV GP vaccine (v920), in the setting of pre-exposure prophylaxis. A booster immunization with the same dose of ... [ Time Frame: months 1,3,6 after vaccination, then every six months for a total of 36 months on study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788227
|United States, Georgia|
|Hope Clinic - Emory Vaccine Ctr|
|Decatur, Georgia, United States, 30030|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Public Health Agency of Canada|
|Principal Investigator:||Richard T Davey, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|