International Technology Transfer of a GCLP-Compliant HIV-1 Neutralizing Antibody Assay for Human Clinical Trials
International Technology Transfer of a GCLP-Compliant HIV-1 Neutralizing Antibody Assay for Human Clinical Trials
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DOI：
10.1371/journal.pone.0030963
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发表时间：
2012-01-27
期刊：
影响因子：
3.7
通讯作者：
Sarzotti-Kelsoe, Marcella
中科院分区：
文献类型：
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作者：
Ozaki, Daniel A.;Gao, Hongmei;Sarzotti-Kelsoe, Marcella
艾滋病疫苗发现/综合抗体疫苗免疫监测联盟(CAVD/CA-VIMC)的合作协助一个国际实验室网络转让了一种符合良好临床实验室规范(GCLP)的用于判断HIV-1疫苗免疫原性的有效检测方法，目的是提高人类免疫缺陷病毒I(HIV-1)疫苗人体临床试验终点检测的质量。选择了国际上的八个区域实验室(区域实验室)，其中许多位于HIV-1疫情最突出的地区，实施了标准化的、符合GCLP的TZM-bl细胞中HIV-1中和抗体检测(TZM-bl NAB检测)。每个实验室都被要求在现场接受初步培训和实施免疫检测，然后进行部分检测重新验证、能力测试，并接受GCLP合规性的正式外部审计。此外，使用新建立的TZM-bl NAB检测的外部水平测试程序，使地区实验室能够评估其现场检测结果与世界各地进行的中和抗体检测结果的可比性。因此，几个CAVD/CA-VIMC区域实验室目前正在进行或计划进行符合GCLP的TZM-bl NAB检测，作为正在进行的人体临床试验的疫苗免疫原性指标。
The Collaboration for AIDS Vaccine Discovery/Comprehensive Antibody - Vaccine Immune Monitoring Consortium (CAVD/CA-VIMC) assisted an international network of laboratories in transferring a validated assay used to judge HIV-1 vaccine immunogenicity in compliance with Good Clinical Laboratory Practice (GCLP) with the goal of adding quality to the conduct of endpoint assays for Human Immunodeficiency Virus I (HIV-1) vaccine human clinical trials. Eight Regional Laboratories in the international setting (Regional Laboratories), many located in regions where the HIV-1 epidemic is most prominent, were selected to implement the standardized, GCLP-compliant Neutralizing Antibody Assay for HIV-1 in TZM-bl Cells (TZM-bl NAb Assay). Each laboratory was required to undergo initial training and implementation of the immunologic assay on-site and then perform partial assay re-validation, competency testing, and undergo formal external audits for GCLP compliance. Furthermore, using a newly established external proficiency testing program for the TZM-bl NAb Assay has allowed the Regional Laboratories to assess the comparability of assay results at their site with the results of neutralizing antibody assays performed around the world. As a result, several of the CAVD/CA-VIMC Regional Laboratories are now in the process of conducting or planning to conduct the GCLP-compliant TZM-bl NAb Assay as an indicator of vaccine immunogenicity for ongoing human clinical trials.