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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,830
- 试验地点
- 4
- 主要终点
- Identify genetic variation associated with mortality from Ebola VirusDisease
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 3 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Identify genetic variation associated with mortality from Ebola VirusDisease
时间窗: At Enrollment
Disease susceptibility and specific symptoms following EBOV infection
Identify genetic variation associated with risk of contracting clinical Ebola Virus Disease when directly exposed to the Ebola virus
时间窗: At Enrollment
Disease susceptibility and specific symptoms following EBOV infection
次要结局
- Identify genetic variation associated with the presence of uveitis among EVD survivors identified in PREVAIL III(At Enrollment)
- Identify genetic variation associated with post recovery Ebola viral RNA persistence in bodily fluids(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)