Zika Virus and Related Arbovirus Infections in Deferred Blood Donors

延迟献血者中的寨卡病毒和相关虫媒病毒感染

• 批准号: 10007376
• 负责人: Valeria de Giorgi
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10007376
• 关键词: Adult; Aedes; Age; Alphavirus; Arbovirus Infections; Area; Argentina; Authorization documentation; Back; Bahamas; Biological Assay; Blood; Blood Banks; Blood Platelets; Blood Transfusion; Blood donor; Blood donor screening; Brazil; Caribbean region; Caucasians; Central America; Chikungunya virus; Clinical; Colombia; Costa Rica; Country; Culicidae; Dengue; Dengue Virus; Detection; Development; Diagnostic; Dominican Republic; Ecuador; El Salvador; Emergency Situation; Enrollment; Epidemic; Exposure to; Female; Flavivirus; India; Indonesia; Jamaica; Laboratories; Martinique; Mexico; Natural History; Nigeria; North America; Outcome; Panama; Patients; Peru; Plasma; Prevalence; Puerto Rico; RNA; Recording of previous events; Reporting; Reverse Transcriptase Polymerase Chain Reaction; Risk; Risk Factors; Sampling; Senegal; Singapore; South America; Symptoms; Tanzania; Testing; Transfusion; Travel; United States National Institutes of Health; United States Virgin Islands; Urine; Validation; Vietnam; Virus Diseases; Visit; Work; Yellow fever virus; ZIKV infection; Zika Virus; base; chikungunya; man; mosquito-borne; multiplex detection; pathogen; transfusion medicine; transmission process; viral RNA; volunteer

Zika virus (ZIKV) is an Aedes species, mosquito-transmitted Flavivirus responsible for an ongoing epidemic in over twenty countries and territories in the Caribbean, and in North, Central and South America. In addition to mosquito-borne transmission, ZIKV can likely be transmitted via blood transfusion and by sexual contact with a ZIKV-infected man. Other Flaviviruses, including yellow fever virus and dengue virus (DENV) are known to be transfusion-transmitted and have resulted in severe outcomes. Chikungunya virus (CHIKV), an alphavirus, has a high theoretical risk of transfusion-related transmission. The ZIKV, DENV and CHIKV infection rates are unknown among U.S. blood donors deferred either for travel to an endemic area or for sexual contact with a partner who travelled to an endemic area. Further, the natural history of ZIKV, DENV and CHIKV among deferred blood donors is not well-defined. Enrollment for this study began in mid June 2016 at the NIH Blood Bank, in the NIH Clinical Center Department of Transfusion Medicine. To date, 34 travel-deferred or potential blood donors who traveled to Zika virus endemic areas have been enrolled and tested using highly sensitive and specific RT-PCR-based assays for ZIKV, DENV1-4 and CHIKV (Altona Diagnostics; under FDA emergency use authorization). Enrollees have mean age of 40, 56% are female, 72% are white or Caucasian and 32% had been blood donors >10 years. Donors and potential donors traveled to 23 different countries or territories with endemic Zika virus, including: Argentina, Brazil, Colombia, Costa Rica, Ecuador, El Salvador, Mexico, Panama and Peru; in the Caribbean: the Bahamas, Dominican Republic, Jamaica, Martinique, Puerto Rico and the US Virgin Islands; elsewhere: India, Indonesia, Nigeria, Senegal, Singapore, Tanzania, UAE and Vietnam. We performed internal validation of the ZIKV RT-PCR kit using clinical samples and determined a limit of detection of approximately 100 copies per mL. Thus far, 32 of 34 deferred or potential blood donors were negative for ZIKV, DENV and CHIKV in plasma and urine. One potential donor was positive for Chikungunya RNA in urine (negative in blood) >2 weeks after mild, CHIKV-related symptoms began during a visit to Ecuador. The patient attributed the mild CHIKV symptoms to strenuous volunteer work she was doing for an aid agency in Ecuador, and would not have been reported as an illness during blood donor screening. One was a Zika virus RNA false-positive. She had no significant travel history or other risk factors and subsequent confirmatory testing was negative. The study has been closed on March 2019.

寨卡病毒（ZIKV）是一种蚊媒传播的黄病毒，在加勒比地区、北美、中美和南美的20多个国家和地区持续流行。 除了蚊媒传播外，ZIKV还可能通过输血和与ZIKV感染者的性接触传播。其他黄病毒，包括黄热病病毒和登革热病毒（DENV），已知可通过输血传播，并导致严重后果。基孔肯雅病毒（CHIKV）是一种甲病毒，理论上具有很高的输血相关传播风险。ZIKV，DENV和CHIKV感染率在美国献血者中是未知的，这些献血者因前往流行地区或与前往流行地区的伴侣发生性接触而被推迟。 此外，延迟献血者中ZIKV、DENV和CHIKV的自然史尚未明确。 本研究的入组于2016年6月中旬在NIH临床中心输血医学部的NIH血库开始。 到目前为止，已经招募了34名前往寨卡病毒流行地区的旅行延期或潜在献血者，并使用高度敏感和特异性的RT-PCR检测ZIKV，DENV 1 -4和CHIKV（Altona Diagnostics;根据FDA紧急使用授权）。 入组者平均年龄为40岁，56%为女性，72%为白色或高加索人，32%为>10年的献血者。 捐赠者和潜在捐赠者前往23个不同的寨卡病毒流行国家或地区，包括：阿根廷、巴西、哥伦比亚、哥斯达黎加、厄瓜多尔、萨尔瓦多、墨西哥、巴拿马和秘鲁;加勒比地区：巴哈马、多米尼加共和国、牙买加、马提尼克、波多黎各和美属维尔京群岛;其他地区：印度、印度尼西亚、尼日利亚、塞内加尔、新加坡、坦桑尼亚、阿联酋和越南。 我们使用临床样品对ZIKV RT-PCR试剂盒进行了内部验证，并确定了约100拷贝/mL的检测限。 到目前为止，34名推迟或潜在献血者中有32人对血浆和尿液中的ZIKV、DENV和CHIKV呈阴性。 一位潜在的捐赠者在访问厄瓜多尔期间开始出现轻度CHIKV相关症状后>2周，尿液中的基孔肯雅RNA呈阳性（血液中为阴性）。患者将轻微的CHIKV症状归因于她为厄瓜多尔的一家援助机构所做的繁重的志愿工作，并且在献血者筛查期间不会被报告为疾病。一个是寨卡病毒RNA假阳性。 她没有明显的旅行史或其他危险因素，随后的确证性检测为阴性。 该研究已于2019年3月关闭。