International technology transfer of a GCLP-compliant HIV-1 neutralizing antibody assay for human clinical trials.
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.
Department of Surgery, Duke University Medical Center, Durham, North Carolina, United States of America.
Daniel A
DA
Ozaki
Hongmei
H
Gao
Christopher A
CA
Todd
Kelli M
KM
Greene
David C
DC
Montefiori
Marcella
M
Sarzotti-Kelsoe
D016915:AIDS Vaccines; D057134:Antibodies, Neutralizing / Q000276:immunology*; D002986:Clinical Trials as Topic / Q000592:standards*; D003637:DEAE-Dextran; D019983:Guideline Adherence / Q000592:standards*; D015483:HIV Antibodies / Q000276:immunology*; D015497:HIV-1 / Q000276:immunology*; D006367:HeLa Cells; D006284:Health Plan Implementation / Q000592:standards; D006801:Humans; D038622:Internationality; D009500:Neutralization Tests / Q000379:methods* / Q000592:standards; D011785:Quality Assurance, Health Care / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D018581:Technology Transfer; D017186:Titrimetry
D016915:AIDS Vaccines; D057134:Antibodies, Neutralizing; D015483:HIV Antibodies; D003637:DEAE-Dextran