- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02431923
Ebola Virus Disease Survivors: Clinical and Immunologic Follow-up
Partnership for Research on Ebola Virus (PREVAIL) Prevail III: Ebola Natural History Study
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kakata, Liberia
- CH Rennie Hospital
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Monrovia, Liberia
- Duport Clinic
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Monrovia, Liberia
- JFK Hospital
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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EVD Survivors
Subject listed on the Ministry of Health registry for Ebola survivors
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Non Contact Controls
Selected Controls
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To characterize the clinical sequelae seen in convalescent Ebola virus disease (EVD) patients.
Time Frame: Throughout
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longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD
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Throughout
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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
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longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD
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Throughout
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Better define the immune response in EVD survivors.
Time Frame: Throughout
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longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD
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Throughout
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Collaborators and Investigators
Publications and helpful links
General Publications
- Rowe AK, Bertolli J, Khan AS, Mukunu R, Muyembe-Tamfum JJ, Bressler D, Williams AJ, Peters CJ, Rodriguez L, Feldmann H, Nichol ST, Rollin PE, Ksiazek TG. Clinical, virologic, and immunologic follow-up of convalescent Ebola hemorrhagic fever patients and their household contacts, Kikwit, Democratic Republic of the Congo. Commission de Lutte contre les Epidemies a Kikwit. J Infect Dis. 1999 Feb;179 Suppl 1:S28-35. doi: 10.1086/514318.
- Kibadi K, Mupapa K, Kuvula K, Massamba M, Ndaberey D, Muyembe-Tamfum JJ, Bwaka MA, De Roo A, Colebunders R. Late ophthalmologic manifestations in survivors of the 1995 Ebola virus epidemic in Kikwit, Democratic Republic of the Congo. J Infect Dis. 1999 Feb;179 Suppl 1:S13-4. doi: 10.1086/514288.
- Postnikova EN, Pettitt J, Van Ryn CJ, Holbrook MR, Bollinger L, Yu S, Cai Y, Liang J, Sneller MC, Jahrling PB, Hensley LE, Kuhn JH, Fallah MP, Bennett RS, Reilly C. Scalable, semi-automated fluorescence reduction neutralization assay for qualitative assessment of Ebola virus-neutralizing antibodies in human clinical samples. PLoS One. 2019 Aug 27;14(8):e0221407. doi: 10.1371/journal.pone.0221407. eCollection 2019.
- PREVAIL III Study Group; Sneller MC, Reilly C, Badio M, Bishop RJ, Eghrari AO, Moses SJ, Johnson KL, Gayedyu-Dennis D, Hensley LE, Higgs ES, Nath A, Tuznik K, Varughese J, Jensen KS, Dighero-Kemp B, Neaton JD, Lane HC, Fallah MP. A Longitudinal Study of Ebola Sequelae in Liberia. N Engl J Med. 2019 Mar 7;380(10):924-934. doi: 10.1056/NEJMoa1805435.
- Kelly JD, Weiser SD, Wilson B, Cooper JB, Glayweon M, Sneller MC, Drew C, Steward WT, Reilly C, Johnson K, Fallah MP. Ebola virus disease-related stigma among survivors declined in Liberia over an 18-month, post-outbreak period: An observational cohort study. PLoS Negl Trop Dis. 2019 Feb 27;13(2):e0007185. doi: 10.1371/journal.pntd.0007185. eCollection 2019 Feb.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 150122
- 15-I-0122
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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