Vaccinology

Covering all aspects of vaccine research and development in one volume, this authoritative resource takes a comprehensive and systematic approach to the science of vaccinology focusing not only on basic science, but also on the many stages required to commercialize and navigate the regulatory requirements for human application, both in the United States and Europe. * Reviews in detail the process of designing a vaccine, from the initial stages of antigen discovery to human application * Includes evaluation of vaccine efficacy and safety * Details clinical trial design, including regulatory requirements * Discusses the emerging field of active cellular immunotherapy Vaccinology: Principles and Practice provides an invaluable resource for clinicians, scientific and medical researchers, lecturers and postdoctoral fellows working in the field of vaccines. W. John W. Morrow, Seattle, Washington, USA Nadeem A. Sheikh, Dendreon, Inc., Seattle, Washington, USA Clint S. Schmidt, NovaDigm Therapeutics, Inc., Grand Forks, North Dakota, USA D. Huw Davies, University of California at Irvine, USA CONTENTS Part 1 Introduction 1 Concept and Scope of Modern Vaccines, 3 D. Huw Davies, Clint S. Schmidt, & Nadeem A. Sheikh Part 2 Principles of Vaccine Design 2 Strategies to Stimulate Innate Immunity for Designing Effective Vaccine Adjuvants, 15 Heather L. Wilson, Scott Napper, George K. Mutwiri, Sylvia van Drunen Littel-van den Hurk, Hugh Townsend, Lorne A. Babiuk, Andrew A. Potter, & Volker Gerdts 3 Antigen Processing and Presentation by MHC Class I, II, and Nonclassical Molecules, 29 Antony N. Antoniou, Izabela Lenart, David B. Guiliano, & Simon J. Powis 4 Understanding the Mucosal Immune System for Better Mucosal Vaccine Design, 47 Janine Bilsborough & Joanne L. Viney 5 Immunologic Memory: T Cells in Humans, 61 Maria Candela Iglesias, Victor Appay, & Arnaud Moris 6 Immunologic Memory: B cells, 79 F. Eun-Hyung Lee & I ˜ naki Sanz 7 Utility of Mouse Models in Vaccine Design and Development, 94 Catharine M. Bosio, Megan MacLeod, Philippa Marrack, & Ross M. Kedl 8 Utility of Nonhuman Primate Models for Vaccines, 110 Preston A. Marx, Jr & Alexander F. Voevodin Part 3 Antigen Discovery 9 Sequence-Based Computational Approaches to Vaccine Discovery and Design, 133 Darrick Carter 10 Antigen Discovery for Vaccines Using High-throughput Proteomic Screening Technologies, 150 D. Huw Davies 11 Phage Libraries, 168 Aaron K. Sato Part 4 Antigen Engineering 12 Attenuated Bacterial Vaccines, 181 Richard W. Titball & Helen S. Atkins 13 Virus-like Particles as Antigen Scaffolds, 196 Bryce Chackerian & John T. Schiller 14 Recombinant MVA vaccines: Optimization, Preclinical, and Product Development, 209 Yper Hall & Miles W. Carroll 15 Recombinant Adenoviruses for Vaccination, 224 Nelson Cesar Di Paolo, Dmitry Shayakhmetov, & Andr´e Lieber 16 Recombinant Avipoxviruses, 237 Michael A. Skinner & Stephen M. Laidlaw 17 Intracellular Facultative Bacterial Vectors for Cancer Immunotherapy, 255 Patrick Guirnalda, Laurence Wood, Matthew Seavey, & Yvonne Paterson 18 Nucleic Acid Vaccination, 275 Britta Wahren & Margaret A. Liu 19 Artificial Antigen-presenting Cells: Large Multivalent Immunogens, 286 Matthew F. Mescher & Julie M. Curtsinger Part 5 Delivery Systems 20 Transcutaneous Immunization via Vaccine Patch Delivery System, 303 Robert C. Seid, Jr & Gregory M. Glenn 21 Needle-free Jet Injection for Vaccine Administration, 324 Brian R. Sloat, Hoi K. Tran, & Zhengrong Cui 22 Oral Vaccines: An Old Need and Some New Possibilities, 336 Amit A. Lugade, Kalathil Suresh, & Yasmin Thanavala 23 Adjuvants: From Serendipity to Rational Discovery, 348 Derek T. O’Hagan & Andreas Wack 24 Immunostimulatory Properties of Biodegradable Microparticles, 361 Fiona A. Sharp & Ed C. Lavelle 25 Co-administration of Co-stimulatory Moieties, 375 Carolina Arancibia-C ´arcamo & Yvette Latchman 26 Toll Receptors in Relation to Adjuvant Effects, 393 Dipshikha Chakravortty, Amit Lahiri, & Priyanka Das Part 6 Regulatory Considerations 27 Regulatory Issues (FDA and EMA), 403 Murrium Ahmad, Victoria Byers, & Peter Wilson Part 7 Evaluating Vaccine Efficacy 28 Immune Monitoring Design within the Developmental Pipeline for an Immunotherapeutic or Preventive Vaccine, 419 Sylvia Janetzki, Pedro Romero, Mario Roederer, Diane L. Bolton, & Camilla Jandus 29 Clinical Development Strategy: Nuts and Bolts, 441 Candida Fratazzi & Claudio Carini 30 Current Approaches to Identify and Evaluate Cancer Biomarkers for Patient Stratification, 452 Robert Rees, Stephanie Laversin, Cliff Murray, & Graham Ball Part 8 Implementing Immunizations/Therapies 31 Mass Immunization Strategies, 467 David L. Heymann, R. Bruce Aylward, & Rudolf H. Tangermann 32 The Role of Mathematical Models in Vaccine Development and Public Health Decision Making, 480 Marie-Claude Boily, Marc Brisson, Benoit Mˆ asse, & Roy M. Anderson 33 Vaccine Safety, 509 John Iskander, Claudia Vellozzi, Jane Gidudu, & Robert T. Chen Index, 525