Vaccinology

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

List of Contributors viii

Preface xii

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 & Iñaki 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, & André 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-Cárcamo & 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 Mâsse, & Roy M. Anderson

33 Vaccine Safety 509
John Iskander, Claudia Vellozzi, Jane Gidudu, & Robert T. Chen

Index 525