Laboratory expansion to large-scale international HIV preventive vaccine trials
Laboratory expansion to large-scale international HIV preventive vaccine trials
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DOI：
10.1097/coh.0b013e3280eec77a
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发表时间：
2007-05-01
影响因子：
4.1
通讯作者：
de Souza, Mark
中科院分区：
文献类型：
--
作者：
Gilmour, Jill W.;Stevens, Wendy S.;de Souza, Mark
目的reviewThe本文的目的是描述临床实验室支持大规模的预防性艾滋病疫苗试验的多国试验的要求，并审查取得的进展。Recent findingsThere是一个越来越需要在非洲，亚洲和加勒比地区的实验室，以支持国际发起和资助的预防性艾滋病疫苗候选人的临床试验。一些合格的实验室目前正在这些区域支助艾滋病疫苗试验，但仍需进一步发展能力。所有测试的标准化是关键，以便数据可以在多个站点和产品之间进行汇总和比较。在实现这一目标方面取得了重大进展。最近制定的质量计划，包括良好的临床实验室规范，是确保数据可靠并满足监管机构要求的关键。此外，正在开发艾滋病毒诊断测试，以区分真正的艾滋病毒感染疫苗诱导的抗体。SummarySignificant进展已经取得了发展实验室能够支持多国艾滋病疫苗试验。
Purpose of reviewThe purpose of this article is to describe the requirements for clinical laboratories supporting large-scale multinational trials of prophylactic AIDS vaccine trials and review the progress made.Recent findingsThere is an increasing need for laboratories in Africa, Asia and the Caribbean to support internationally initiated and funded clinical trials of preventive HIV vaccine candidates. A number of qualified laboratories are currently supporting AIDS vaccine trials in these regions, although there remains a need to develop capacity further. The standardization of all tests is key in order that data can be pooled and compared across multiple sites and products. Significant progress has been made towards this aim. The recent development of quality programmes including good clinical laboratory practices are key to ensuring data are reliable and meet the requirements of regulatory bodies. In addition, HIV diagnostic tests are being developed to distinguish true HIV infection from vaccine-induced antibodies.SummarySignificant advances have been made to develop laboratories capable of supporting multinational AIDS vaccine trials.