PREVAIL VI: Identification of Host Genetic Factors Underlying Ebola Virus Disease Risk, Mortality, Long-term Sequelae, Viral RNA Persistence, Humoral Immunity, and Ebola Vaccine Response
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03098862|
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : December 28, 2020
Genes are instructions that tell the body how to work and grow. They can affect how the body responds to infection. Researchers want to learn more about genes that affect how the body responds to the Ebola virus. Some people with Ebola get very sick and die. Others do not. The research may lead to better treatments for Ebola virus and other germs.
To look for genes that may be related to a person s chance of getting very sick after coming in contact with the Ebola virus.
People at least 3 years of age who either:
Had close contact with someone who had Ebola
Were in an Ebola vaccine study
Participants will have a small amount of blood taken from an arm vein by a needle.
Researchers will collect participants data from other vaccine studies they may have been in.
Participants may be asked questions about their health and social history.
Some participants will have their blood tested for the infection syphilis and HIV, the virus that causes AIDS. Participants will be told the results and will get help finding care, if necessary.
Some participants will have their blood sample tested to see if they have had Ebola in the past.
Blood samples will be stored for future research. They will be marked with a code but not with participants names.
|Condition or disease|
|Ebola Virus Disease|
The 2013-2015 Ebola Virus outbreak in Western Africa was unprecedented in size and geographic scope. There were over 28,000 cases and 11,000 deaths. During and following the outbreak, it became evident that spectrum of disease being observed in the communities and the Ebola treatment units was much broader than previously thought. In this study, we aim to identify host genetic factors that underlie the observed variation in disease susceptibility, severity, clinical sequelae, viral persistence, and serological response. We will enroll EVD survivors, close contacts of survivors, EVD healthcare workers, and individuals who have received investigational Ebola vaccines (population controls), and collect a blood sample, HIV/syphilis infection status, demographics, and medical history from participants.
Most subjects will complete study participation after a single study visit; subjects having Ebola serology and/or HIV/syphilis testing done as part of this study will return for one or two follow-up visits to receive their HIV/syphilis test results and post-test counseling and Ebola serology results. We will genotype participants and compare results between cohorts to address the study aims. This may provide insight into pathogenesis and host immunity and potentially suggest new methods of intervention.
|Study Type :||Observational|
|Actual Enrollment :||4830 participants|
|Official Title:||PREVAIL VI: Identification of Host Genetic Factors Underlying Ebola Virus Disease Risk, Mortality, Long-term Sequelae, Viral RNA Persistence, Humoral Immunity, and Ebola Vaccine Response|
|Actual Study Start Date :||September 4, 2017|
|Actual Primary Completion Date :||May 2, 2019|
|Actual Study Completion Date :||December 23, 2020|
|Direct EBOV exposure risk controls|
|EVD fatal cases|
|EVD survibor cases|
|No Known EBOV exposure population controls|
- Identify genetic variation associated with risk of contracting clinical Ebola Virus Disease when directly exposed to the Ebola virus [ Time Frame: At Enrollment ]Disease susceptibility and specific symptoms following EBOV infection
- Identify genetic variation associated with mortality from Ebola VirusDisease [ Time Frame: At Enrollment ]Disease susceptibility and specific symptoms following EBOV infection
- Identify genetic variation associated with post recovery Ebola viral RNA persistence in bodily fluids [ Time Frame: At Enrollment ]
- Identify genetic variation associated with the presence of uveitis among EVD survivors identified in PREVAIL III [ Time Frame: At Enrollment ]
- Identify genetic variation associated with the magnitude and duration of anti-EBOV IgG titer in both EVD cases and vaccine recipients enrolled in PREVAIL I or PREVAC/PREVAIL V trials [ Time Frame: At Enrollment ]
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): NCT03098862
|PREVAIL C. H. Rennie Hospital|
|PREVAIL JFK Medical Center|
|PREVAIL Redemption Hospital|
|PREVAIL Duport Road Clinic|
|Principal Investigator:||Lisa Hensley, Ph.D.||National Institute of Allergy and Infectious Diseases (NIAID)|