The Risk of Transfusion Transmission of Hepatitis E Virus

戊型肝炎病毒输血传播的风险

• 批准号: 8620291
• 负责人: Kenrad E Nelson
• 金额: $ 28.38万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-01-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8620291
• 关键词: Acute; Acute Hepatitis; Address; Adult; Advisory Committees; Afghanistan; Africa; Allogenic; American; Animals; Asia; Blood Transfusion; Blood donor; Blood specimen; Cardiac Surgery procedures; Case Study; Centers for Disease Control and Prevention (U.S.); China; Chinese People; Chronic; Chronic Hepatitis; Cirrhosis; Clinical; Country; Data; Detection; Diagnostic Reagent; Disease Outbreaks; Donor Selection; Elderly; Enrollment; Enzymes; Epidemiology; Etiology; Europe; Family suidae; Food; Funding; HIV; Hepatitis; Hepatitis B; Hepatitis B Virus; Hepatitis C virus; Hepatitis E virus; Hospitals; Human; Immune; Immunity; Immunocompromised Host; Immunoglobulin G; Immunoglobulin M; Incidence; Individual; Infection; Infectious Agent; Japan; Laboratories; Licensing; Link; Literature; Liver; Liver Failure; Liver diseases; Measures; Meat; Medical; Morbidity - disease rate; National Health and Nutrition Examination Survey; National Heart, Lung, and Blood Institute; Operative Surgical Procedures; Organ; Oryctolagus cuniculus; Paper; Patients; Persons; Plasma; Policies; Population; Population Research; Pregnant Women; Prevalence; Prevalence Study; Reporting; Research; Research Methodology; Retroviridae; Risk; Risk Estimate; Rodent; Sampling; Seroprevalences; Serum; Shellfish; Specimen; Study of serum; Testing; Texas; Transfusion; Transplant Recipients; United States; Viremia; Virus; Virus Diseases; Voting; Water; blood product; chronic liver disease; cohort; high risk; male; meetings; mortality; pathogen; prevent; public health relevance; repository; transmission process; viral RNA; volunteer

ABSTRACT/SUMMARY Hepatitis E virus (HEV) has been recognized as an important cause of human hepatitis worldwide, since it was shown to be responsible for water-born outbreaks in Asia two decades ago. The virus is now known to cause clinical and subclinical hepatitis in the United States, Europe and other countries from a zoonotic reservoir in pigs and other animals. Since HEV infection typically causes silent infection in adults, it can also be transmitted by blood transfusion from asymptotic donors. However, despite a few case reports from Europe and Japan and the detection of HEV RNA in plasma pools, the risk of transfusion transmission in the US and elsewhere is unknown. HEV infection in immunocompromised patients, pregnant women and patients with liver disease can have serious morbidity or mortality. In this study we will estimate the risk of transmission of HEV by blood product transfusion by studying three populations. We will study the prevalence of anti-HEV IgM and HEV RNA in a serum repository obtained from 5,000 Chinese blood donors with elevated liver enzymes who were not infected with hepatitis B and C. Secondly, we will measure the rate of sero-conversion among a sample of 11,532 patients enrolled in the NHLBI-funded FACTS study in the early 1990's. In this study, 9,294 patients were transfused with blood products from over 120,000 donors and 2,238 similar subjects were not transfused, who will serve as controls. Third, we will measure the risk of transfusion transmission of HEV in 3,575 patients with RADAR study. The RADAR study is a linked donor-recipient repository. We will test the donors linked to any patients who have sero-converted after their transfusion for evidence of active HEV infection, i.e. HEV RNA and anti-HEV IgM. Strains of HEV from donors and recipients will be sequenced when possible. We will also test 100 mini-pools of 50 plasma samples, i.e. 5,000 individual samples, from the RADAR repository that are unlinked to a recipient. Positive pools will be re-tested sequentially to resolve infectivity of an individual donor. These three inter-related studies will allow us to estimate the level of risk of transmission of HEV by transfusion of blood products. If this risk is confirmed, our data can be used to develop policies for screening donors to prevent the recent documented serious clinical consequences of HEV infection among high risk patients.

摘要/摘要 肝炎病毒（HEV）被认为是全球人类肝炎的重要原因，因为 事实证明，这是二十年前亚洲出生的爆发。该病毒现在已知 在美国，欧洲和其他国家引起临床和亚临床肝炎 猪和其他动物的水库。由于HEV感染通常会引起成年人的沉默感染，因此也可以 通过渐近供体输血传播。但是，尽管有一些案例报告 欧洲和日本以及在血浆池中检测HEV RNA，是输血传播的风险 我们和其他地方是未知的。免疫功能低下的患者，孕妇和 肝病患者可能患有严重的发病率或死亡率。在这项研究中，我们将估计 通过研究三个人群通过血液产物输血传播HEV。我们将研究 从5,000名中国献血者获得的血清存储库中抗HEV IGM和HEV RNA的患病率 肝酶升高，未感染丙型肝炎和C。其次，我们将测量 NHLBI资助的事实研究中的11,532名患者的样本中的血清转换率 1990年代初。在这项研究中，有9,294名患者从120,000多名供体中输血 2,238个类似的受试者没有被输血，他们将用作对照。第三，我们将衡量 3,575例雷达研究患者的HEV输血传播。雷达研究是链接的 捐赠者录音库。我们将测试与任何患者相关的捐赠者， 输血是活跃HEV感染的证据，即HEV RNA和抗HEV IGM。 hev菌株 捐助者和接收者将在可能的情况下进行测序。我们还将测试50个血浆的100个迷你池 样本，即5,000个单独的样本，来自雷达存储库，这些样本未链接到接受者。积极的 池将进行依次进行测试，以解决单个捐助者的感染性。这三个相关 研究将使我们能够通过输血来估计HEV传播的风险水平。如果 确认了这种风险，我们的数据可用于制定筛查捐赠者的政策，以防止最近 记录了高风险患者HEV感染的严重临床后果。