International technology transfer of a GCLP-compliant HIV-1 neutralizing antibody assay for human clinical trials

PLoS One. 2012;7(1):e30963. doi: 10.1371/journal.pone.0030963. Epub 2012 Jan 27.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • AIDS Vaccines
  • Antibodies, Neutralizing / immunology*
  • Clinical Trials as Topic / standards*
  • DEAE-Dextran
  • Guideline Adherence / standards*
  • HIV Antibodies / immunology*
  • HIV-1 / immunology*
  • HeLa Cells
  • Health Plan Implementation / standards
  • Humans
  • Internationality*
  • Neutralization Tests / methods*
  • Neutralization Tests / standards
  • Quality Assurance, Health Care / standards
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Technology Transfer*
  • Titrimetry

Substances

  • AIDS Vaccines
  • Antibodies, Neutralizing
  • HIV Antibodies
  • DEAE-Dextran