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Mode of action of adjuvants: Implications for vaccine safety and design
Authors:Béatris Mastelic  Sohail Ahmed  William M. Egan  Giuseppe Del Giudice  Hana Golding  Ian Gust  Pieter Neels  Steven G. Reed  Rebecca L. Sheets  Claire-Anne Siegrist  Paul-Henri Lambert
Affiliation:1. WHO-Center for Vaccinology and Neonatal Immunology, CMU, 1 rue Michel-Servet, 1211 Geneva, 4, Switzerland;2. Novartis Vaccines and Diagnostics, Via Fiorentina 1, 53100 Siena, Italy;3. PharmaNet Consulting, 504 Carnegie Center, Princeton, NJ 08540, USA;4. Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892-0001, USA;5. The University of Melbourne, Department of Microbiology and Immunology, Parkville, Victoria 3010, Australia;6. Federal Agency for Medicines and Health Products, EMEA-CHMP, Belgium;7. Infectious Disease Research Institute, 1124 Columbia Street, Seattle, Washington 98104, USA;8. CAPT, U.S. Public Health Service, Vaccine Scientific & Regulatory Specialist, NIH/NIAID 6700B Rockledge Dr., MSC-7628, Bethesda, MD 20892-7628, USA
Abstract:For decades, the search for new vaccine adjuvants has been largely empirical. A series of new adjuvants and related formulations are now emerging that are acting through identified immunological mechanisms. Understanding adjuvant mechanism of action is crucial for vaccine design, since this allows for directing immune responses towards efficacious disease-specific effector mechanisms and appropriate memory. It is also of great importance to build new paradigms for assessing adjuvant safety at development stages and at regulatory level. This report reflects the conclusions of a group of scientists from academia, regulatory agencies and industry who attended a conference, organized by the International Association for Biologicals (IABS), on the mode of action of adjuvants on 29–30 April 2010 in Bethesda, Maryland, USA, particularly focusing on how understanding adjuvants mode of action can impact on the assessment of vaccine safety and help to develop target-specific vaccines. More information on the conference output can be found on the IABS website, http://www.iabs.org/.
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