Ebola Virus Disease Survivors: Clinical and Immunologic Follow-up

Study Overview
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Brief Summary
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Background: - 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. Objectives: - To learn how Ebola affects the health of survivors and the people they live with. Eligibility: - 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. Design: 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.

Detailed Description
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Between 1994 and the present, there have been several Ebola virus outbreaks affecting mostly countries in Central Africa. However, the 2014 West African outbreak significantly exceeds all previous outbreaks in geographic range and number of individuals affected. Ebola virus disease (EVD) is highly lethal with case fatality rates of 70-80% in the current West African outbreak. While the clinical manifestations of acute Ebola virus infection are well documented, little is known about long-term sequelae, ability to transmit Ebola, or long-term protective immunity in survivors from EVD. The purpose of this protocol is to study these questions in a cohort of EVD survivors from Liberia.

Official Title
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Partnership for Research on Ebola Virus (PREVAIL) Prevail III: Ebola Natural History Study

Conditions
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Ebola Virus Disease

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EVD Close Contacts<br>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 | |
| EVD Survivors<br>Subject listed on the Ministry of Health registry for Ebola survivors | |
| Non Contact Controls<br>Selected Controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the clinical sequelae seen in convalescent Ebola virus disease (EVD) patients. | longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD | Throughout | 
| Assess whether convalescent EVD patients can transmit infection to household and sexual contacts as determined by development of EVD or Ebola seroconversion in contacts | longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD | Throughout | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Better define the immune response in EVD survivors. | longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD | Throughout | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sequelae, Seroprevalence, Household Contacts, Natural History