EbolaNCT06811129
Long-Term Neurologic and Neurocognitive Sequelae Following Pediatric Ebola Virus in Liberia
An observational study of Ebola and Post-Acute Ebola Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in Liberia.
Trial summary
Background: Ebola virus disease (EVD) causes fever, vomiting, and diarrhea, and may cause internal bleeding. It is often fatal. EVD may also damage the brain and nervous system. It can cause headaches, tremors, weakness, and other problems. These issues can continue for years after people recover from EVD infection. Read more about this study
- Who is it for?
- Ages 7 to 30 years
- Conditions the study is for
- Ebola, Post-Acute Ebola Syndrome
- How many people
- 328 participants
- Where
- 1 siteLiberia
- Study dates
- 14 Feb 2025to 9 Sep 2025
- 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 7 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study will include participants of the PREVAIL III Natural History of Ebola Study who were of pediatric age at the time of enrollment, including EVD survivors and close contacts.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, previously enrolled in PREVAIL III Natural History of Ebola study as either an EVD survivor, or a close contact.*
- Aged < 18 Years Old at the time of enrollment in PREVAIL III Natural History of Ebola study.
- Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
- Close contacts are those who had a relationship with someone who survived EVD but were never diagnosed with EVD themselves.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- At the time of enrollment, lacks consent capacity due to cognitive impairment that would make them incapable of understanding the explanation of the procedures in this study. Cognitive capacity to consent will be determined at the time of enrollment. Participants with mental disorders or those participants who are cognitively impaired yet still retain consent capacity will not be excluded.
- Is unable to comply with the procedures of the protocol.
- Has any condition in the judgement of the study staff that would make the volunteer unable to participate in the study.
- Is non-English speaking.
- Justification for the Exclusion of Non-English Speakers
- We plan to include speakers of simple Liberian English in this study. The tools we use for cognitive testing are not validated in any other language, other than English. It is expected that most, if not all, of the cohort we will be recruiting from will be simple Liberian English speakers.
Trial locations and contacts
1 site in 1 country.
About this study
Background:
Ebola virus disease (EVD) causes fever, vomiting, and diarrhea, and may cause internal bleeding. It is often fatal. EVD may also damage the brain and nervous system. It can cause headaches, tremors, weakness, and other problems. These issues can continue for years after people recover from EVD infection. Researchers want to understand more about how EVD may have affected the brains of people who contracted the disease as children.
Read more
Objective:
To learn more about the long-term effects of EVD on the brain and nervous system in people who had the disease as children.
Eligibility:
People who were less than 18 years old when they took part in a previous study called the PREVAIL III Natural History of Ebola study. They can be either a survivor of EVD or a close contact. A close contact is someone who had a relationship with a person who survived EVD but never had the disease themself.
Design:
Participants will have 1 clinic visit. They will undergo several tasks:
They will have an exam of their nervous system performed by a neurologist. They will do physical tasks and answer questions about any problems or symptoms since they had EVD.
They may have blood drawn.
They will have tests of their memory, attention, and thinking skills. For one test, participants will answer questions and solve puzzles using pencil and paper. For another test, they will play 4 different games on an iPad.
They will have an interview. A researcher will ask questions about their mood and other symptoms that may affect their brain and nervous system; their past medical diagnoses, symptoms, and experiences; and how they are doing at home, school, or work.
Read the detailed description
Study Description:
The long-term neurological sequelae of Ebola virus disease (EVD) are not well-described, particularly in survivors infected during pediatric age. The 2015 west Africa EVD epidemic had dramatic effect on adults and children and by one year following infection, concerns for neurologic sequelae became apparent. The PREVAIL III (PIII) Ebola Natural History Study in Monrovia, Liberia had a number of substudies, including both an adult Neurology and pediatric Neurology Substudy which were undertaken to better understand the long-term neurologic sequelae of EVD. The adult Neurology Substudy had over five years of follow up visits whereas the original Pediatric Neurology Substudy cohort was composed of a small sample of children seen in 2015 one time under PIII with no subsequent follow ups. Although this pediatric cohort was small, pilot data from this assessment revealed lower cognitive scores in the pediatric EVD survivors compared to controls, as well as worse executive function scores, more complaints of neuropsychiatric symptoms, and worse disability on modified Rankin Scale, among other findings. PIII subsequently closed out between 2020 and 2021. Here we propose a new protocol to observe and study the neurologic and neurocognitive sequelae following Ebola virus exposure at an age below 18. We propose conducting a single in-person neurologic visit including neurologic exam, neurocognitive assessment, and neurologic history and symptom questionnaire to be given to participants at greater than 5-years following exposure. We also plan to do a single blood draw at time of visit to assess for Ebola Virus antibody titers in survivors and close contacts (controls). The participants included in this study will include Ebola survivors and close contacts (controls) that were enrolled in PIII at age less than 18. We hypothesize that some pediatric Ebola survivors will have longterm neurologic sequelae at greater than 5 years post exposure that may be subtle in nature. Included in this study will be one embedded substudy.
Longitudinal Pediatric Neuro EVD Substudy: We propose to see the original small cohort of pediatric participants seen in 2015 for a second visit as a longitudinal sub study. In evaluating our longitudinal cohort, we expect that some of the sequelae noted during their initial evaluation may have improved over time, but these survivors still may have persistent neurological sequelae even after over 5 years convalescence from EVD.
Objectives:
Primary Objective:
- Pediatric EVD Neuro Follow up Study: To observe and describe the range of neurologic and neurocognitive findings that are present in EVD survivors at greater than 5 years following infection as compared to controls.
- Longitudinal Pediatric Neuro EVD Substudy (Subset of population): To compare neurologic and neurocognitive findings found in EVD survivors and controls at greater than 5 years following infection to that of the same participants at first visit about 1 year post infection.
Secondary Objectives
- Pediatric EVD Neuro Follow up Study: To characterize serum Zaire Ebola virus (EBOV) specific antibodies in pediatric EVD survivors at greater than 5 years following infection compared to that of controls.
- Longitudinal Pediatric Neuro EVD Substudy: To characterize serum EBOV specific antibodies in pediatric EVD survivors at greater than 5 years following infection to that of the same participant at first visit about 1 year post infection.
Exploratory Objective:
Pediatric EVD Neuro Follow up Study
- To compare EBOV specific antibodies in pediatric EVD survivors with and without neurologic and neurocognitive sequelae.
- To compare neurologic and neurocognitive findings in pediatric EVD survivors and controls at greater than 5 years post infection to that of adult participants from the PIII adult Neurology sub study.
- To explore the presence of other serologic markers in pediatric EVD survivors compared to close-contacts (control).
Outcomes:
Primary Endpoint:
- Pediatric EVD Neuro Follow up Study: In comparison of EVD survivors at greater than 5 years following infection with close contacts (controls), the prevalence of:
- neurological symptoms (as asked on neurologic symptom questionnaire CRF)
- physical disability (as assessed through MRS score)
- executive function dysfunction (as assessed through executive function assessment questions)
- neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF)
- neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit)
- neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam and ICA-P assessment)
- Longitudinal Pediatric Neuro EVD Substudy: In comparison of EVD survivors at greater than 5 years following infection to that at first visit about 1 year after infection, the change in:
- number of neurological symptoms (as asked on neurologic symptom questionnaire CRF)
- Physical disability (as assessed through MRS score)
- Executive function dysfunction (as assessed through executive function assessment questions).
- number of neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF.
- persistence of neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit).
- neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam and ICA-P assessment).
Secondary Endpoints:
- Pediatric EVD Neuro Follow up Study: The degree of antibody response in pediatric EVD survivors at greater than 5 years following infection compared to that of close contacts (controls).
- Longitudinal Pediatric Neuro EVD Substudy: The degree of antibody response in pediatric EVD survivors at greater than 5 years following infection compared to that at about 1 year following infection.
Exploratory Endpoints:
Pediatric EVD Neuro Follow up Study:
- In EVD survivors at greater than 5 years post infection, the correlation between serum EBOV specific antibody presence and:
- presence of neurological symptoms (as asked on neurologic symptom questionnaire CRF).
- presence of physical disability (as assessed through MRS score).
- presence of executive function dysfunction (as assessed through executive function assessment questions)
- presence of neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF)
- presence of neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit).
- presence of neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam)
- In pediatric versus adult EVD survivors at greater than 5 years following infection, the prevalence of:
- neurological symptoms (as asked on neurologic symptom questionnaire CRF).
- physical disability (as assessed through MRS score)
- neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF)
- neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit)
- neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam).
- The profile of serologic immune markers in pediatric EVD survivors at greater than 5 years following infection.
- Conditions
- Ebola, Post-Acute Ebola Syndrome
- Keywords
- Ebola, Neurologic, Pediatric, Post-Acute Ebola Syndrome, Cognitive, Global Neurology
- Medical subject headings
- Hemorrhagic Fever, Ebola, Neurologic Manifestations
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 |
|---|---|---|
| Close Contacts | Male of female, previously enrolled in PREVAIL III Natural History of Ebola study as a close contact. Close contacts are those who had a relationship with someone who survived EVD but were never diagnosed with EVD themselves. | |
| EVD Survivors | Male or female, previously enrolled in PREVAIL III Natural History of Ebola study as an EVD survivor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric EVD Neuro Follow up Study
To observe and describe the range of neurologic and neurocognitive findings that are present in EVD survivors at greater than 5 years following infection as compared to controls. In comparison of EVD survivors at greater than 5 years following infection with close contacts, the prevalence of:- neurological symptoms (as asked on neurologic symptom questionnaire CRF) - physical disability (as assessed through MRS score) - executive function dysfunction (as assessed through executive function assessment questions) - neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF) - neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit) - neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam and ICA-P assessment)
Measured: 5-10 years post-infection
Longitudinal Pediatric Neuro EVD Sub study (Subset of population)
To compare neurologic and neurocognitive findings found in EVD survivors and controls at greater than 5 years following infection to that of the same participants at first visit about 1 year post infection.- number of neurological symptoms (as asked on neurologic symptom questionnaire CRF) - Physical disability (as assessed through MRS score) - Executive function dysfunction (as assessed through executive function assessment questions).- number of neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF.- persistence of neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit).- neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam and ICA-P assessment).
Measured: 5-10 years post-infection
Secondary outcomes (2)
Longitudinal Pediatric Neuro EVD Sub study:
The degree of antibody response in pediatric EVD survivors after 5 years or more of convalescence from EVD compared to that at 1 year following infection.
Measured: 5-10 years post-infection
Pediatric EVD Neuro Follow up Study
The degree of antibody response in pediatric EVD survivors after 5 years or more of convalescence from EVD compared to that of controls.
Measured: 5-10 years post-infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start14 Feb 2025
- Primary completion9 Sep 2025
- Study completion9 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for EbolaStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)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
- Cross-sectional
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Bridgette J Billioux, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811129
- Sponsor's protocol ID
- 10001809
- Other IDs
- 001809-N
- Status last verified
- 16 Mar 2026
- First submitted
- 5 Feb 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bwaka MA, Bonnet MJ, Calain P, Colebunders R, De Roo A, Guimard Y, Katwiki KR, Kibadi K, Kipasa MA, Kuvula KJ, Mapanda BB, Massamba M, Mupapa KD, Muyembe-Tamfum JJ, Ndaberey E, Peters CJ, Rollin PE, Van den Enden E, Van den Enden E. Ebola hemorrhagic fever in Kikwit, Democratic Republic of the Congo: clinical observations in 103 patients. J Infect Dis. 1999 Feb;179 Suppl 1:S1-7. doi: 10.1086/514308.
PubMed 9988155Clark DV, Kibuuka H, Millard M, Wakabi S, Lukwago L, Taylor A, Eller MA, Eller LA, Michael NL, Honko AN, Olinger GG Jr, Schoepp RJ, Hepburn MJ, Hensley LE, Robb ML. Long-term sequelae after Ebola virus disease in Bundibugyo, Uganda: a retrospective cohort study. Lancet Infect Dis. 2015 Aug;15(8):905-12. doi: 10.1016/S1473-3099(15)70152-0. Epub 2015 Apr 21.
PubMed 25910637Schieffelin JS, Shaffer JG, Goba A, Gbakie M, Gire SK, Colubri A, Sealfon RS, Kanneh L, Moigboi A, Momoh M, Fullah M, Moses LM, Brown BL, Andersen KG, Winnicki S, Schaffner SF, Park DJ, Yozwiak NL, Jiang PP, Kargbo D, Jalloh S, Fonnie M, Sinnah V, French I, Kovoma A, Kamara FK, Tucker V, Konuwa E, Sellu J, Mustapha I, Foday M, Yillah M, Kanneh F, Saffa S, Massally JL, Boisen ML, Branco LM, Vandi MA, Grant DS, Happi C, Gevao SM, Fletcher TE, Fowler RA, Bausch DG, Sabeti PC, Khan SH, Garry RF; KGH Lassa Fever Program; Viral Hemorrhagic Fever Consortium; WHO Clinical Response Team. Clinical illness and outcomes in patients with Ebola in Sierra Leone. N Engl J Med. 2014 Nov 27;371(22):2092-100. doi: 10.1056/NEJMoa1411680. Epub 2014 Oct 29.
PubMed 25353969Chertow DS, Nath A, Suffredini AF, Danner RL, Reich DS, Bishop RJ, Childs RW, Arai AE, Palmore TN, Lane HC, Fauci AS, Davey RT. Severe Meningoencephalitis in a Case of Ebola Virus Disease: A Case Report. Ann Intern Med. 2016 Aug 16;165(4):301-4. doi: 10.7326/M15-3066. Epub 2016 Apr 5. No abstract available.
PubMed 27043004Howlett P, Brown C, Helderman T, Brooks T, Lisk D, Deen G, Solbrig M, Lado M. Ebola Virus Disease Complicated by Late-Onset Encephalitis and Polyarthritis, Sierra Leone. Emerg Infect Dis. 2016 Jan;22(1):150-2. doi: 10.3201/eid2201.151212. No abstract available.
PubMed 26690042Jacobs M, Rodger A, Bell DJ, Bhagani S, Cropley I, Filipe A, Gifford RJ, Hopkins S, Hughes J, Jabeen F, Johannessen I, Karageorgopoulos D, Lackenby A, Lester R, Liu RS, MacConnachie A, Mahungu T, Martin D, Marshall N, Mepham S, Orton R, Palmarini M, Patel M, Perry C, Peters SE, Porter D, Ritchie D, Ritchie ND, Seaton RA, Sreenu VB, Templeton K, Warren S, Wilkie GS, Zambon M, Gopal R, Thomson EC. Late Ebola virus relapse causing meningoencephalitis: a case report. Lancet. 2016 Jul 30;388(10043):498-503. doi: 10.1016/S0140-6736(16)30386-5. Epub 2016 May 18.
PubMed 27209148Fallah MP, Reilly C, Van Ryn C, Badio M, Camanor SW, Kaler SG, Johnson B, Orone R, Flumo H, Moses SJ, Johnson KL, Gorpudolo N, Gayedyu-Dennis D, Dighero-Kemp B, Fayiah J, Marron L, Hensley LE, Taylor RJ, Higgs ES, Lane HC, Neaton JD, Sneller MC. Pregnancy, pregnancy outcomes, and infant growth and development after recovery from Ebola virus disease in Liberia: an observational cohort study. Lancet Glob Health. 2023 Jul;11(7):e1053-e1060. doi: 10.1016/S2214-109X(23)00210-3.
PubMed 37349033Foeller ME, Carvalho Ribeiro do Valle C, Foeller TM, Oladapo OT, Roos E, Thorson AE. Pregnancy and breastfeeding in the context of Ebola: a systematic review. Lancet Infect Dis. 2020 Jul;20(7):e149-e158. doi: 10.1016/S1473-3099(20)30194-8. Epub 2020 May 6.
PubMed 32595045PREVAIL 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.
PubMed 30855742Diallo MSK, Ayouba A, Keita AK, Thaurignac G, Sow MS, Kpamou C, Barry TA, Msellati P, Etard JF, Peeters M, Ecochard R, Delaporte E, Toure A; PostEbogui Study Group. Temporal evolution of the humoral antibody response after Ebola virus disease in Guinea: a 60-month observational prospective cohort study. Lancet Microbe. 2021 Dec;2(12):e676-e684. doi: 10.1016/S2666-5247(21)00170-1. Epub 2021 Sep 3.
PubMed 35544108
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Neurologic and Neurocognitive Sequelae Following Pediatric Ebola Virus in Liberia
- ClinicalTrials.gov ID
- NCT06811129
- Acronym / sponsor ID
- 10001809
- Conditions
- Ebola, Post-Acute Ebola Syndrome
- Keywords
- Ebola, Neurologic, Pediatric, Post-Acute Ebola Syndrome, Cognitive, Global Neurology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 9 Sep 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 6 Feb 2025 (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:
Ebola virus disease (EVD) causes fever, vomiting, and diarrhea, and may cause internal bleeding. It is often fatal. EVD may also damage the brain and nervous system. It can cause headaches, tremors, weakness, and other problems. These issues can continue for years after people recover from EVD infection. Researchers want to understand more about how EVD may have affected the brains of people who contracted the disease as children.
Objective:
To learn more about the long-term effects of EVD on the brain and nervous system in people who had the disease as children.
Eligibility:
People who were less than 18 years old when they took part in a previous study called the PREVAIL III Natural History of Ebola study. They can be either a survivor of EVD or a close contact. A close contact is someone who had a relationship with a person who survived EVD but never had the disease themself.
Design:
Participants will have 1 clinic visit. They will undergo several tasks:
They will have an exam of their nervous system performed by a neurologist. They will do physical tasks and answer questions about any problems or symptoms since they had EVD.
They may have blood drawn.
They will have tests of their memory, attention, and thinking skills. For one test, participants will answer questions and solve puzzles using pencil and paper. For another test, they will play 4 different games on an iPad.
They will have an interview. A researcher will ask questions about their mood and other symptoms that may affect their brain and nervous system; their past medical diagnoses, symptoms, and experiences; and how they are doing at home, school, or work.
Detailed description
Study Description:
The long-term neurological sequelae of Ebola virus disease (EVD) are not well-described, particularly in survivors infected during pediatric age. The 2015 west Africa EVD epidemic had dramatic effect on adults and children and by one year following infection, concerns for neurologic sequelae became apparent. The PREVAIL III (PIII) Ebola Natural History Study in Monrovia, Liberia had a number of substudies, including both an adult Neurology and pediatric Neurology Substudy which were undertaken to better understand the long-term neurologic sequelae of EVD. The adult Neurology Substudy had over five years of follow up visits whereas the original Pediatric Neurology Substudy cohort was composed of a small sample of children seen in 2015 one time under PIII with no subsequent follow ups. Although this pediatric cohort was small, pilot data from this assessment revealed lower cognitive scores in the pediatric EVD survivors compared to controls, as well as worse executive function scores, more complaints of neuropsychiatric symptoms, and worse disability on modified Rankin Scale, among other findings. PIII subsequently closed out between 2020 and 2021. Here we propose a new protocol to observe and study the neurologic and neurocognitive sequelae following Ebola virus exposure at an age below 18. We propose conducting a single in-person neurologic visit including neurologic exam, neurocognitive assessment, and neurologic history and symptom questionnaire to be given to participants at greater than 5-years following exposure. We also plan to do a single blood draw at time of visit to assess for Ebola Virus antibody titers in survivors and close contacts (controls). The participants included in this study will include Ebola survivors and close contacts (controls) that were enrolled in PIII at age less than 18. We hypothesize that some pediatric Ebola survivors will have longterm neurologic sequelae at greater than 5 years post exposure that may be subtle in nature. Included in this study will be one embedded substudy.
Longitudinal Pediatric Neuro EVD Substudy: We propose to see the original small cohort of pediatric participants seen in 2015 for a second visit as a longitudinal sub study. In evaluating our longitudinal cohort, we expect that some of the sequelae noted during their initial evaluation may have improved over time, but these survivors still may have persistent neurological sequelae even after over 5 years convalescence from EVD.
Objectives:
Primary Objective:
- Pediatric EVD Neuro Follow up Study: To observe and describe the range of neurologic and neurocognitive findings that are present in EVD survivors at greater than 5 years following infection as compared to controls.
- Longitudinal Pediatric Neuro EVD Substudy (Subset of population): To compare neurologic and neurocognitive findings found in EVD survivors and controls at greater than 5 years following infection to that of the same participants at first visit about 1 year post infection.
Secondary Objectives
- Pediatric EVD Neuro Follow up Study: To characterize serum Zaire Ebola virus (EBOV) specific antibodies in pediatric EVD survivors at greater than 5 years following infection compared to that of controls.
- Longitudinal Pediatric Neuro EVD Substudy: To characterize serum EBOV specific antibodies in pediatric EVD survivors at greater than 5 years following infection to that of the same participant at first visit about 1 year post infection.
Exploratory Objective:
Pediatric EVD Neuro Follow up Study
- To compare EBOV specific antibodies in pediatric EVD survivors with and without neurologic and neurocognitive sequelae.
- To compare neurologic and neurocognitive findings in pediatric EVD survivors and controls at greater than 5 years post infection to that of adult participants from the PIII adult Neurology sub study.
- To explore the presence of other serologic markers in pediatric EVD survivors compared to close-contacts (control).
Outcomes:
Primary Endpoint:
- Pediatric EVD Neuro Follow up Study: In comparison of EVD survivors at greater than 5 years following infection with close contacts (controls), the prevalence of:
- neurological symptoms (as asked on neurologic symptom questionnaire CRF)
- physical disability (as assessed through MRS score)
- executive function dysfunction (as assessed through executive function assessment questions)
- neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF)
- neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit)
- neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam and ICA-P assessment)
- Longitudinal Pediatric Neuro EVD Substudy: In comparison of EVD survivors at greater than 5 years following infection to that at first visit about 1 year after infection, the change in:
- number of neurological symptoms (as asked on neurologic symptom questionnaire CRF)
- Physical disability (as assessed through MRS score)
- Executive function dysfunction (as assessed through executive function assessment questions).
- number of neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF.
- persistence of neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit).
- neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam and ICA-P assessment).
Secondary Endpoints:
- Pediatric EVD Neuro Follow up Study: The degree of antibody response in pediatric EVD survivors at greater than 5 years following infection compared to that of close contacts (controls).
- Longitudinal Pediatric Neuro EVD Substudy: The degree of antibody response in pediatric EVD survivors at greater than 5 years following infection compared to that at about 1 year following infection.
Exploratory Endpoints:
Pediatric EVD Neuro Follow up Study:
- In EVD survivors at greater than 5 years post infection, the correlation between serum EBOV specific antibody presence and:
- presence of neurological symptoms (as asked on neurologic symptom questionnaire CRF).
- presence of physical disability (as assessed through MRS score).
- presence of executive function dysfunction (as assessed through executive function assessment questions)
- presence of neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF)
- presence of neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit).
- presence of neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam)
- In pediatric versus adult EVD survivors at greater than 5 years following infection, the prevalence of:
- neurological symptoms (as asked on neurologic symptom questionnaire CRF).
- physical disability (as assessed through MRS score)
- neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF)
- neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit)
- neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam).
- The profile of serologic immune markers in pediatric EVD survivors at greater than 5 years following infection.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Close Contacts | – | –Male of female, previously enrolled in PREVAIL III Natural History of Ebola study as a close contact. Close contacts are those who had a relationship with someone who survived EVD but were never diagnosed with EVD themselves. |
| EVD Survivors | – | –Male or female, previously enrolled in PREVAIL III Natural History of Ebola study as an EVD survivor. |
Who may qualify
- Ages
- 7 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study will include participants of the PREVAIL III Natural History of Ebola Study who were of pediatric age at the time of enrollment, including EVD survivors and close contacts.
Key inclusion criteria (6 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, previously enrolled in PREVAIL III Natural History of Ebola study as either an EVD survivor, or a close contact.*
- Aged < 18 Years Old at the time of enrollment in PREVAIL III Natural History of Ebola study.
- Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (7 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- At the time of enrollment, lacks consent capacity due to cognitive impairment that would make them incapable of understanding the explanation of the procedures in this study. Cognitive capacity to consent will be determined at the time of enrollment. Participants with mental disorders or those participants who are cognitively impaired yet still retain consent capacity will not be excluded.
- Is unable to comply with the procedures of the protocol.
- Has any condition in the judgement of the study staff that would make the volunteer unable to participate in the study.
- Is non-English speaking.
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
Pediatric EVD Neuro Follow up Study
Time frame: 5-10 years post-infection
To observe and describe the range of neurologic and neurocognitive findings that are present in EVD survivors at greater than 5 years following infection as compared to controls. In comparison of EVD survivors at greater than 5 years following infection with close contacts, the prevalence of:- neurological symptoms (as asked on neurologic symptom questionnaire CRF) - physical disability (as assessed through MRS score) - executive function dysfunction (as assessed through executive function assessment questions) - neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF) - neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit) - neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam and ICA-P assessment)
Longitudinal Pediatric Neuro EVD Sub study (Subset of population)
Time frame: 5-10 years post-infection
To compare neurologic and neurocognitive findings found in EVD survivors and controls at greater than 5 years following infection to that of the same participants at first visit about 1 year post infection.- number of neurological symptoms (as asked on neurologic symptom questionnaire CRF) - Physical disability (as assessed through MRS score) - Executive function dysfunction (as assessed through executive function assessment questions).- number of neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF.- persistence of neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit).- neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam and ICA-P assessment).
2 secondary outcomes
Longitudinal Pediatric Neuro EVD Sub study:
Time frame: 5-10 years post-infection
Pediatric EVD Neuro Follow up Study
Time frame: 5-10 years post-infection
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 29 Oct 2026.
- Background: PubMed 9988155Bwaka MA, Bonnet MJ, Calain P, Colebunders R, De Roo A, Guimard Y, Katwiki KR, Kibadi K, Kipasa MA, Kuvula KJ, Mapanda BB, Massamba M, Mupapa KD, Muyembe-Tamfum JJ, Ndaberey E, Peters CJ, Rollin PE, Van den Enden E, Van den Enden E. Ebola hemorrhagic fever in Kikwit, Democratic Republic of the Congo: clinical observations in 103 patients. J Infect Dis. 1999 Feb;179 Suppl 1:S1-7. doi: 10.1086/514308.
- Background: PubMed 25910637Clark DV, Kibuuka H, Millard M, Wakabi S, Lukwago L, Taylor A, Eller MA, Eller LA, Michael NL, Honko AN, Olinger GG Jr, Schoepp RJ, Hepburn MJ, Hensley LE, Robb ML. Long-term sequelae after Ebola virus disease in Bundibugyo, Uganda: a retrospective cohort study. Lancet Infect Dis. 2015 Aug;15(8):905-12. doi: 10.1016/S1473-3099(15)70152-0. Epub 2015 Apr 21.
- Background: PubMed 25353969Schieffelin JS, Shaffer JG, Goba A, Gbakie M, Gire SK, Colubri A, Sealfon RS, Kanneh L, Moigboi A, Momoh M, Fullah M, Moses LM, Brown BL, Andersen KG, Winnicki S, Schaffner SF, Park DJ, Yozwiak NL, Jiang PP, Kargbo D, Jalloh S, Fonnie M, Sinnah V, French I, Kovoma A, Kamara FK, Tucker V, Konuwa E, Sellu J, Mustapha I, Foday M, Yillah M, Kanneh F, Saffa S, Massally JL, Boisen ML, Branco LM, Vandi MA, Grant DS, Happi C, Gevao SM, Fletcher TE, Fowler RA, Bausch DG, Sabeti PC, Khan SH, Garry RF; KGH Lassa Fever Program; Viral Hemorrhagic Fever Consortium; WHO Clinical Response Team. Clinical illness and outcomes in patients with Ebola in Sierra Leone. N Engl J Med. 2014 Nov 27;371(22):2092-100. doi: 10.1056/NEJMoa1411680. Epub 2014 Oct 29.
- Background: PubMed 27043004Chertow DS, Nath A, Suffredini AF, Danner RL, Reich DS, Bishop RJ, Childs RW, Arai AE, Palmore TN, Lane HC, Fauci AS, Davey RT. Severe Meningoencephalitis in a Case of Ebola Virus Disease: A Case Report. Ann Intern Med. 2016 Aug 16;165(4):301-4. doi: 10.7326/M15-3066. Epub 2016 Apr 5. No abstract available.
- Background: PubMed 26690042Howlett P, Brown C, Helderman T, Brooks T, Lisk D, Deen G, Solbrig M, Lado M. Ebola Virus Disease Complicated by Late-Onset Encephalitis and Polyarthritis, Sierra Leone. Emerg Infect Dis. 2016 Jan;22(1):150-2. doi: 10.3201/eid2201.151212. No abstract available.
- Background: PubMed 27209148Jacobs M, Rodger A, Bell DJ, Bhagani S, Cropley I, Filipe A, Gifford RJ, Hopkins S, Hughes J, Jabeen F, Johannessen I, Karageorgopoulos D, Lackenby A, Lester R, Liu RS, MacConnachie A, Mahungu T, Martin D, Marshall N, Mepham S, Orton R, Palmarini M, Patel M, Perry C, Peters SE, Porter D, Ritchie D, Ritchie ND, Seaton RA, Sreenu VB, Templeton K, Warren S, Wilkie GS, Zambon M, Gopal R, Thomson EC. Late Ebola virus relapse causing meningoencephalitis: a case report. Lancet. 2016 Jul 30;388(10043):498-503. doi: 10.1016/S0140-6736(16)30386-5. Epub 2016 May 18.
- Background: PubMed 37349033Fallah MP, Reilly C, Van Ryn C, Badio M, Camanor SW, Kaler SG, Johnson B, Orone R, Flumo H, Moses SJ, Johnson KL, Gorpudolo N, Gayedyu-Dennis D, Dighero-Kemp B, Fayiah J, Marron L, Hensley LE, Taylor RJ, Higgs ES, Lane HC, Neaton JD, Sneller MC. Pregnancy, pregnancy outcomes, and infant growth and development after recovery from Ebola virus disease in Liberia: an observational cohort study. Lancet Glob Health. 2023 Jul;11(7):e1053-e1060. doi: 10.1016/S2214-109X(23)00210-3.
- Background: PubMed 32595045Foeller ME, Carvalho Ribeiro do Valle C, Foeller TM, Oladapo OT, Roos E, Thorson AE. Pregnancy and breastfeeding in the context of Ebola: a systematic review. Lancet Infect Dis. 2020 Jul;20(7):e149-e158. doi: 10.1016/S1473-3099(20)30194-8. Epub 2020 May 6.
- Background: PubMed 30855742PREVAIL 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.
- Background: PubMed 35544108Diallo MSK, Ayouba A, Keita AK, Thaurignac G, Sow MS, Kpamou C, Barry TA, Msellati P, Etard JF, Peeters M, Ecochard R, Delaporte E, Toure A; PostEbogui Study Group. Temporal evolution of the humoral antibody response after Ebola virus disease in Guinea: a 60-month observational prospective cohort study. Lancet Microbe. 2021 Dec;2(12):e676-e684. doi: 10.1016/S2666-5247(21)00170-1. Epub 2021 Sep 3.
- Individual participant dataSharing planned: No
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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.
Bridgette J Billioux, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ebola and Post-Acute Ebola Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site 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 6 inclusion and 7 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Pediatric EVD Neuro Follow up Study (time frame: 5-10 years post-infection). 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 NCT06811129, which also lists 10 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 29 Oct 2026.