Dengue surveillance in preparation for field vaccine trials
Dengue surveillance in preparation for field vaccine trials
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DOI：
10.1016/s1386-6532(09)70288-4
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发表时间：
2009-10-01
影响因子：
8.8
通讯作者：
Letson, G. William
中科院分区：
文献类型：
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作者：
Letson, G. William
登革热疫苗试验的准备工作以及疫苗引进战略需要在国际和协调一级进行以实验室为基础的监测。儿科登革热疫苗倡议（PDVI）在拉丁美洲和亚洲建立了一个由实地站点组成的国际联盟。这些站点开展基于社区和加强的被动实验室登革热监测。通过这个联盟，PDVI正在促进统一的基于实验室的监测过程，以便可以比较不同区域和国家之间的疾病发病率。这一过程为严格的病例发现、诊断、记录和分析做好准备，以满足临床登革热疫苗试验所需的良好临床实践标准。除了几年来以实验室为基础的登革热监测数据外，登革热疫苗试验点的标准还包括地方性疾病地区人口迁移率低、其他当地黄病毒流行病学记录、良好的医疗基础设施、政治稳定、国家和目标人群对疫苗试验的承诺以及对疫苗的需求。预防登革热是登革热疫苗概念验证试验最合适的主要终点。然而，这些试验可能为根据不同的危险因素和病毒血清型对结果进行分层分析提供的信息不足。因此，可能需要进行大规模的社区示范试验。(C) 2009年Elsevier B.V.出版
Preparations for dengue vaccine trials as well as vaccine introduction strategies require laboratory-based surveillance on an international and coordinated level. The Pediatric Dengue Vaccine Initiative (PDVI) has developed an international consortium of field sites in Latin America and Asia. These sites conduct community-based and enhanced passive laboratory-based surveillance of dengue fever. Through this consortium, PDVI is facilitating harmonised laboratory-based surveillance processes, so that disease incidence can be compared between different regions and countries. This process prepares sites for the rigorous case detection, diagnosis, recording and analysis to meet good clinical practice standards necessary for clinical dengue vaccine trials. In addition to several years of laboratory-based dengue surveillance data, dengue vaccine trial site criteria include low population migration of an endemic disease area, documentation of other local flavivirus epidemiology, good medical infrastructure, political stability, and country and target population commitment to vaccine trials and need for vaccine. Prevention of dengue fever is the most suitable primary end point for a proof-of-concept dengue vaccine trial. However, such trials may provide insufficient information for stratified analysis of outcomes according to varied risk factors and virus serotype. Consequently large community-based demonstration trials may be necessary. (C) 2009 Published by Elsevier B.V.