title: Introduction to a Special Issue of the Journal of Immunological Methods: Building global resource programs to support HIV/AIDS clinical trial studies.
abstract: This Special Issue of the Journal of Immunological Methods includes 16 manuscripts describing quality assurance activities related to virologic and immunologic monitoring of six global laboratory resource programs that support international HIV/AIDS clinical trial studies: Collaboration for AIDS Vaccine Discovery (CAVD); Center for HIV/AIDS Vaccine Immunology (CHAVI); External Quality Assurance Program Oversight Laboratory (EQAPOL); HIV Vaccine Trial Network (HVTN); International AIDS Vaccine Initiative (IAVI); and Immunology Quality Assessment (IQA). The reports from these programs address the many components required to develop comprehensive quality control activities and subsequent quality assurance programs for immune monitoring in global clinical trials including: all aspects of processing, storing, and quality assessment of PBMC preparations used ubiquitously in HIV clinical trials, the development and optimization of assays for CD8 HIV responses and HIV neutralization, a comprehensive global HIV virus repository, and reports on the development and execution of novel external proficiency testing programs for immunophenotyping, intracellular cytokine staining, ELISPOT and luminex based cytokine measurements. In addition, there are articles describing the implementation of Good Clinical Laboratory Practices (GCLP) in a large quality assurance laboratory, the development of statistical methods specific for external proficiency testing assessment, a discussion on the ability to set objective thresholds for measuring rare events by flow cytometry, and finally, a manuscript which addresses a framework for the structured reporting of T cell immune function based assays. It is anticipated that this series of manuscripts covering a wide range of quality assurance activities associated with the conduct of global clinical trials will provide a resource for individuals and programs involved in improving the harmonization, standardization, accuracy, and sensitivity of virologic and immunologic testing.
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA. Electronic address: ana.sanchez@duke.edu.
authors.forename: Ana M
authors.initials: AM
authors.lastname: Sanchez
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Thomas N
authors.initials: TN
authors.lastname: Denny
authors.affiliation: Departments of Pathology and Pediatrics, Keck School of Medicine, University of Southern California, USA; Department of Pathology and Laboratory Medicine, Children's Hospital Los Angeles, Los Angeles, CA, USA.
authors.forename: Maurice
authors.initials: M
authors.lastname: O'Gorman
mesh_terms: D016915:AIDS Vaccines / Q000627:therapeutic use*; D000163:Acquired Immunodeficiency Syndrome / Q000175:diagnosis / Q000276:immunology / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000592:standards*; D032921:Consensus; D003299:Cooperative Behavior; D019983:Guideline Adherence / Q000592:standards; D015658:HIV Infections / Q000175:diagnosis / Q000276:immunology / Q000628:therapy* / Q000821:virology; D006801:Humans; D007159:Immunologic Tests / Q000592:standards*; D007391:International Cooperation; D007753:Laboratories / Q000592:standards*; D059021:Laboratory Proficiency Testing / Q000592:standards*; D015166:Monitoring, Immunologic / Q000592:standards*; D015588:Observer Variation; D017410:Practice Guidelines as Topic / Q000592:standards; D011237:Predictive Value of Tests; D016730:Program Development; D015397:Program Evaluation; D011786:Quality Control; D015203:Reproducibility of Results; D016896:Treatment Outcome
chemical_list: D016915:AIDS Vaccines
keywords: CAVD; CHAVI; EQAPOL; HVTN; IAVI; IQA