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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

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ClinicalTrials.gov Identifier: NCT03098862
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Tracking Information
First Submitted Date March 30, 2017
First Posted Date April 4, 2017
Last Update Posted Date May 6, 2019
Actual Study Start Date September 4, 2017
Actual Primary Completion Date May 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 30, 2017)
  • Identify genetic variation associated with risk of contracting clinical Ebola Virus Disease when directly exposed to the Ebola virus [ Time Frame: At Enrollment ]
  • Identify genetic variation associated with mortality from Ebola VirusDisease [ Time Frame: At Enrollment ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03098862 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 30, 2017)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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
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
Brief 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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population We will enroll EVD survivors, close contacts of survivors, EVD healthcare workers, and individuals who have received investigational Ebola vaccines (population controls)
Condition Ebola Virus Disease
Intervention Not Provided
Study Groups/Cohorts
  • 1
    EVD survivors
  • 2
    close contacts of survivors
  • 3
    EVD healthcare workers
  • 4
    individuals who have received investigational Ebola vaccines (population controls)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 3, 2019)
4798
Original Estimated Enrollment
 (submitted: March 30, 2017)
8000
Actual Study Completion Date May 2, 2019
Actual Primary Completion Date May 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • INCLUSION CRITERIA:
  • EVD Survivor:

    • At least 3 years of age
    • Positive EBOV serology or documented RT-PCR positive status
    • Willing to allow storage of biological samples for future research purposes
  • Direct EBOV exposure control:

    • At least 3 years of age
    • Meets at least 1 of the following:

      • Household member, family member, friend, care-provider, or sexual partner of survivor who was in close-contact with the survivor within 3 weeks of the EVD event, and has no history of an ETU stay or treatment for EVD at a CCC or holding center
      • Healthcare worker who participated in treatment of EVD patients with no history of an ETU stay or treatment for EVD at a CCC or holding center
      • Participant in PREVAIL III enrolled as a close-contact
    • Willing to allow storage of biological samples for future research purposes
  • No known EBOV exposure population controls:

    • At least 3 years of age.
    • Meets at least 1 of the following:

      • Enrolled in PREVAIL I
      • Enrolled in PREVAC/PREVAIL V
    • Willing to allow storage of biological samples for future research purposes

EXCLUSION CRITERIA:

  • Severe illness from current illness (e.g. malaria) requiring treatment that would be compromised by enrollment in this study. Individuals excluded due to current illness can be enrolled following recovery.
  • Any condition in the judgement of the study staff that would make the volunteer unable to participate in the study.
  • Incapacity to provide consent, e.g., because of decisional impairment.
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Liberia
Removed Location Countries  
 
Administrative Information
NCT Number NCT03098862
Other Study ID Numbers 999917077
17-I-N077
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators Not Provided
Investigators
Principal Investigator: Lisa Hensley, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date May 2, 2019