Ebola Virus Disease Survivors: Clinical and Immunologic Follow-up
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|ClinicalTrials.gov Identifier: NCT02431923|
Recruitment Status : Completed
First Posted : May 1, 2015
Last Update Posted : October 10, 2022
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- Ebola is a lethal disease. A lot is still unknown about Ebola and its long-term effects. Researchers want to learn what ill health conditions Ebola survivors have. They want to learn if Ebola survivors can infect others in their household through close contact. They also want to learn if Ebola survivors are immune from getting Ebola again. To learn these things, they want to follow people in Liberia for 5 years.
- To learn how Ebola affects the health of survivors and the people they live with.
- People in Liberia who had Ebola in the past 2 years, who share a household with someone who had Ebola, or who got ill and went to an Ebola Treatment Unit but were sent home because they did not have Ebola.
- Participants will be screened with family illness history, physical exam, and blood tests. They may have an eye exam.
- Ebola survivors and those who went to a Treatment Unit but did not have Ebola will visit a clinic at 3, 6, and 12 months, then every 6 months for 5 years. At each visit, they will repeat the screening tests.
- Participants who live with someone who had Ebola will have only the screening visit. But they may be asked to return for follow-up visits. These visits will help researchers learn more about the differences between those who have had Ebola and those who have not.
- Participants brought to the NIH Clinical Center will have documentation of positive Ebola virus PCR and a clinical syndrome compatible with acute EVD.
- The study will last 5 years.
|Condition or disease|
|Ebola Virus Disease|
|Study Type :||Observational|
|Actual Enrollment :||4043 participants|
|Official Title:||Partnership for Research on Ebola Virus (PREVAIL) Prevail III: Ebola Natural History Study|
|Actual Study Start Date :||December 2, 2017|
|Actual Primary Completion Date :||April 30, 2021|
|Actual Study Completion Date :||April 30, 2021|
EVD Close Contacts
At least one of the following:-Household contact of survivor at time of or since EVD event-Sexual contact with survivor since EVD event-Other selected contacts
Subject listed on the Ministry of Health registry for Ebola survivors
Non Contact Controls
- To characterize the clinical sequelae seen in convalescent Ebola virus disease (EVD) patients. [ Time Frame: Throughout ]longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD
- Assess whether convalescent EVD patients can transmit infection to household and sexual contacts as determined by development of EVD or Ebola seroconversion in contacts [ Time Frame: Throughout ]longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD
- Better define the immune response in EVD survivors. [ Time Frame: Throughout ]longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD
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|Ages Eligible for Study:||up to 100 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- INCLUSION CRITERIA FOR EVD SURVIVORS
A volunteer of any age with a diagnosis of EVD within the past 2 years who is on the Ministry of Health (MOH) Registry of EVD survivors is eligible to participate.
- Willingness to participate in examinations at one of the participating health facilities
- Willingness to provide informed consent/assent
Individuals on the MOH Registry were PCR positive for EVD and treated at an Ebola Treatment Unit (ETU), Community Care Center (CCC) or holding center. Periodically, participants enrolled will be matched against the MOH Registry to verify that those enrolled are EVD survivors. If a participant enrolled is not on the registry, their antibody levels at baseline will be assessed. If antibody levels are present, the participant will continue to be followed as an EVD survivor. If antibody levels are not present, the participants will no longer be followed as an EVD survivor and may be withdrawn from the study. Participants brought to the NIH Clinical Center will have documentation of positive Ebola virus PCR and a clinical syndrome compatible with acute EVD.
EXCLUSION CRITERION FOR EVD SURVIVORS
Any condition in the judgment of the study staff that would make the volunteer unable to participate in the 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): NCT02431923
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|CH Rennie Hospital|
|Principal Investigator:||Michael C Sneller, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|Other Study ID Numbers:||
|First Posted:||May 1, 2015 Key Record Dates|
|Last Update Posted:||October 10, 2022|
|Last Verified:||October 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections