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Nonclinical testing of vaccines: Report from a workshop

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Author: Laan, J.W. van der · Forster, R. · Ledwith, B. · Gruber, M. · Gould, S. · Segal, L. · Penninks, A.
Type:article
Date:2009
Institution: TNO Kwaliteit van Leven
Source:Drug Information Journal, 1, 43, 97-107
Identifier: 241417
Keywords: Health · Adjuvants · Developmental and reproductive toxicology · DNA vaccines · Nonclinical evaluation · Safety testing · Therapeutic vaccines · Vaccines · diphtheria pertussis tetanus vaccine · DNA vaccine · immunological adjuvant · immunomodulating agent · live vaccine · Meningococcus vaccine · pertussis vaccine · vaccine · Wart virus vaccine · conference paper · disease model · drug dose regimen · drug efficacy · drug research · drug safety · drug screening · drug tolerability · electroporation · human · immune response · immunogenicity · male fertility · nonhuman · pharmacodynamics · practice guideline · priority journal · reproductive toxicity · tattooing · toxicity testing · toxicology · vaccination · workshop

Abstract

Vaccine research and development is a heterogeneous and intensely active area, encompassing the development of many different kinds of novel preventive and therapeutic vaccines (eg, against infectious, allergic, and autoimmune diseases, cancer, etc). Included in this is the development of different types of vaccines (eg, DNA vaccines, novel routes of administration, novel adjuvants, and immune system modulation). This poses challenges regarding approaches to preclinical evaluation of these products. Published regulatory guidance has not always kept up with scientific advances and innovation in this area and, at the same time, many vaccine developers are interested in better understanding and meeting regulatory expectations. It was in this context that in June 2007 a workshop was organized and held in Amsterdam (DIA International Workshop on Nonclinical Testing of Vaccines) to discuss the nonclinical aspects of vaccine development. This article provides a short historical overview of preclinical testing of vaccines and reviews and summarizes the discussions held during the June 2007 meeting. Copyright © 2009 Drug Information Association, Inc.