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
Condition: Ebola Virus Disease
MeSH terms: Virus Diseases; Hemorrhagic Fever, Ebola
Study type: Observational

Summary: 
      Background:

      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.

      Objective:

      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.

      Eligibility:

      People at least 3 years of age who either:

      Had Ebola

      Had close contact with someone who had Ebola

      Were in an Ebola vaccine study

      Design:

      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.
    

Detailed description: 
      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.
    

Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        EVD survivors, close contacts of survivors, EVD healthcare workers, and individuals who
        have received investigational Ebola vaccines (population controls)
      
Keywords: Ebola Virus; Genome-Wide Association Study; Liberia; Ebola Survivors; Ebola Contacts; Natural History