Ebola Virus DiseaseNCT03098862
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
An observational study of Ebola Virus Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in Liberia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 99 years
- Conditions the study is for
- Ebola Virus Disease
- How many people
- 4,830 participants
- Where
- 4 sitesLiberia
- Study dates
- 4 Sep 2017to 23 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: EVD survivors, close contacts of survivors, EVD healthcare workers, and individuals who have received investigational Ebola vaccines (population controls)
Who may be able to join
- 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
Show all 17Show fewer
- 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 even if he/she withdraws from the study.
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Liberia4 sites
PREVAIL C. H. Rennie Hospital
Kalkata
PREVAIL JFK Medical Center
Monrovia
PREVAIL Redemption Hospital
Monrovia
PREVAIL Duport Road Clinic
Paynesville
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Ebola Virus Disease
- Keywords
- Ebola Virus, Genome-Wide Association Study, Liberia, Ebola Survivors, Ebola Contacts, Natural History
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Direct EBOV exposure risk controls | |
| 2 | EVD fatal cases | |
| 3 | EVD survivor cases | |
| 4 | No known EBOV exposure population controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify genetic variation associated with risk of contracting clinical Ebola Virus Disease when directly exposed to the Ebola virus
Disease susceptibility and specific symptoms following EBOV infection
Measured: At Enrollment
Identify genetic variation associated with mortality from Ebola VirusDisease
Disease susceptibility and specific symptoms following EBOV infection
Measured: At Enrollment
Secondary outcomes (3)
Identify genetic variation associated with post recovery Ebola viral RNA persistence in bodily fluids
Measured: At Enrollment
Identify genetic variation associated with the presence of uveitis among EVD survivors identified in PREVAIL III
Measured: 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
Measured: At Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start4 Sep 2017
- Primary completion28 Feb 2019
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ebola Virus DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 4,830 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lisa Hensley, Ph.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098862
- Sponsor's protocol ID
- 999917077
- Other IDs
- 17-I-N077
- Status last verified
- Aug 2022
- First submitted
- 30 Mar 2017
- Last updated
- 22 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rasmussen AL, Okumura A, Ferris MT, Green R, Feldmann F, Kelly SM, Scott DP, Safronetz D, Haddock E, LaCasse R, Thomas MJ, Sova P, Carter VS, Weiss JM, Miller DR, Shaw GD, Korth MJ, Heise MT, Baric RS, de Villena FP, Feldmann H, Katze MG. Host genetic diversity enables Ebola hemorrhagic fever pathogenesis and resistance. Science. 2014 Nov 21;346(6212):987-91. doi: 10.1126/science.1259595. Epub 2014 Oct 30.
PubMed 25359852Leroy EM, Baize S, Volchkov VE, Fisher-Hoch SP, Georges-Courbot MC, Lansoud-Soukate J, Capron M, Debre P, McCormick JB, Georges AJ. Human asymptomatic Ebola infection and strong inflammatory response. Lancet. 2000 Jun 24;355(9222):2210-5. doi: 10.1016/s0140-6736(00)02405-3.
PubMed 10881895Baize S, Leroy EM, Georges-Courbot MC, Capron M, Lansoud-Soukate J, Debre P, Fisher-Hoch SP, McCormick JB, Georges AJ. Defective humoral responses and extensive intravascular apoptosis are associated with fatal outcome in Ebola virus-infected patients. Nat Med. 1999 Apr;5(4):423-6. doi: 10.1038/7422.
PubMed 10202932
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03098862
- Acronym / sponsor ID
- 999917077
- Conditions
- Ebola Virus Disease
- Keywords
- Ebola Virus, Genome-Wide Association Study, Liberia, Ebola Survivors, Ebola Contacts, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,830 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Direct EBOV exposure risk controls |
| 2 | – | –EVD fatal cases |
| 3 | – | –EVD survivor cases |
| 4 | – | –No known EBOV exposure population controls |
Who may qualify
- Ages
- 3 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- EVD survivors, close contacts of survivors, EVD healthcare workers, and individuals who have received investigational Ebola vaccines (population controls)
Key inclusion criteria (17 listed)
- EVD Survivor:
- Direct EBOV exposure control:
- No known EBOV exposure population controls:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify genetic variation associated with risk of contracting clinical Ebola Virus Disease when directly exposed to the Ebola virus
Time frame: At Enrollment
Disease susceptibility and specific symptoms following EBOV infection
Identify genetic variation associated with mortality from Ebola VirusDisease
Time frame: At Enrollment
Disease susceptibility and specific symptoms following EBOV infection
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Background: PubMed 25359852Rasmussen AL, Okumura A, Ferris MT, Green R, Feldmann F, Kelly SM, Scott DP, Safronetz D, Haddock E, LaCasse R, Thomas MJ, Sova P, Carter VS, Weiss JM, Miller DR, Shaw GD, Korth MJ, Heise MT, Baric RS, de Villena FP, Feldmann H, Katze MG. Host genetic diversity enables Ebola hemorrhagic fever pathogenesis and resistance. Science. 2014 Nov 21;346(6212):987-91. doi: 10.1126/science.1259595. Epub 2014 Oct 30.
- Background: PubMed 10881895Leroy EM, Baize S, Volchkov VE, Fisher-Hoch SP, Georges-Courbot MC, Lansoud-Soukate J, Capron M, Debre P, McCormick JB, Georges AJ. Human asymptomatic Ebola infection and strong inflammatory response. Lancet. 2000 Jun 24;355(9222):2210-5. doi: 10.1016/s0140-6736(00)02405-3.
- Background: PubMed 10202932Baize S, Leroy EM, Georges-Courbot MC, Capron M, Lansoud-Soukate J, Debre P, Fisher-Hoch SP, McCormick JB, Georges AJ. Defective humoral responses and extensive intravascular apoptosis are associated with fatal outcome in Ebola virus-infected patients. Nat Med. 1999 Apr;5(4):423-6. doi: 10.1038/7422.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Hensley, Ph.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ebola Virus Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in Liberia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Liberia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify genetic variation associated with risk of contracting clinical Ebola Virus Disease when directly exposed to the Ebola virus (time frame: At Enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03098862, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.