Utilization of serologic assays to support efficacy of vaccines in nonclinical and clinical trials: Meeting at the Crossroads

Abstract

In May 2009 the National Institute of Allergy and Infectious Diseases hosted a workshop on serologic assays that support vaccine efficacy evaluations. The meeting promoted exchange of ideas among investigators from varying disciplines who are working on anti-infectious agent vaccines at different stages of development. The presentations and discussions at the workshop illustrated the challenges common across various pathogens with recurring themes: 1) A thorough understanding of the science regarding the pathogen and the host response to disease and immunization is fundamental to assay Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. NIH Public Access Author ManuscriptVaccine. Author manuscript; available in PMC 2011 June 23. 2) The intended use of the immunoassay data must be clearly defined to ensure appropriate specificity, accuracy, and precision; a laboratory must also commit resources to assure data quality and reliability. 3) During vaccine development, an immunoassay may evolve with respect to quality, purpose, and degree of standardization, and, in some cases, must be changed or replaced as data are accumulated. 4) Collaboration on standardized reagents and methods, harmonization efforts, and multidisciplinary teams facilitates consistent generation of quality data. This report provides guidance for effective development and utilization of immunoassays based on the lessons learned from currently licensed vaccines. Investigators are encouraged to create additional opportunities for scientific exchange, noting that the discussed themes are relevant for immunoassays used for other purposes such as therapeutics and diagnostics. Keywords serology; vaccine; immunoassay A. IntroductionOn May 5-6, 2009, in Bethesda MD, the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID) hosted a workshop on the use of serologic assays to support vaccine efficacy in clinical studies. The purpose of this meeting was to provide a forum for the exchange of ideas among researchers and clinicians and to identify some common themes across pathogens and technologies regarding the development and use of immunoassays. Participants in the meeting were those involved in vaccine or immunotherapeutic development programs that have been evaluated in clinical trials as well as those that are expected to enter Phase I clinical trials in the near future. Also attending were regulatory reviewers involved in evaluation of clinical and non-clinical assay data.Generation of clinical data demonstrating efficacy and safety remain the gold st...

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