Ebola Virus Disease Survivors: Clinical and Immunologic Follow-up
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 100 |
| Updated: | 3/9/2019 |
| Start Date: | April 30, 2015 |
| End Date: | June 30, 2020 |
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.
- 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.
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.
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.
- 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.
We found this trial at
2
sites
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9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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