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

NCT03098862 | Completed

• 2 other identifiers: 99991707717-I-N077
• Study Type: observational
• Target: 4,830
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Ebola Virus Disease

Keywords

Ebola Virus; Genome-Wide Association Study; Liberia; Ebola Survivors; Ebola Contacts; Natural History

Outcome Measures

Primary Outcomes (2)

• 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

  At Enrollment

• Identify genetic variation associated with mortality from Ebola VirusDisease

  Disease susceptibility and specific symptoms following EBOV infection

  At Enrollment

Secondary Outcomes (3)

• Identify genetic variation associated with post recovery Ebola viral RNA persistence in bodily fluids

  At Enrollment

• Identify genetic variation associated with the presence of uveitis among EVD survivors identified in PREVAIL III

  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

  At Enrollment

Study Arms (4)

1

Direct EBOV exposure risk controls

2

EVD fatal cases

3

EVD survivor cases

4

No known EBOV exposure population controls

Eligibility Criteria

• Age: 3 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

EVD survivors, close contacts of survivors, EVD healthcare workers, and individuals who have received investigational Ebola vaccines (population controls)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (4)

PREVAIL C. H. Rennie Hospital

Kalkata, Liberia

Location

PREVAIL JFK Medical Center

Monrovia, Liberia

Location

PREVAIL Redemption Hospital

Monrovia, Liberia

Location

PREVAIL Duport Road Clinic

Paynesville, Liberia

Location

Related Publications (3)

• 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.

  PMID: 25359852 BACKGROUND

• Leroy 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.

  PMID: 10881895 BACKGROUND

• Baize 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.

  PMID: 10202932 BACKGROUND

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Study Officials

• Lisa Hensley, Ph.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 4, 2017
• Study Start: September 4, 2017
• Primary Completion: February 28, 2019
• Study Completion: December 23, 2020
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

LI (4)