New generation vaccines

Foreword Gustav J. V. Nossal iii Preface to the Third Edition v Preface to the Second Edition vii Introduction to Vaccinology 1. Vaccines and Vaccination in Historical Perspective 1 Myron M. Levine and Rosanna Lagos 2. An Overview of Biotechnology in Vaccine Development 11 James B. Kaper and Rino Rappuoli 3. Initial Clinical Evaluation of New Vaccine Candidates: Investigators’ Perspective of Phase I and II Clinical Trials of Safety, Immunogenicity, and Preliminary Efficacy 19 CarolO. Tacket, Karen L. Kotloff, and Margaret B. Rennels 4. Long-Term Evaluation of Vaccine Protection: Methodological Issues for Phase III and IV Studies 29 John D. Clemens, Abdollah Naficy, Malla R. Rao, and Hye-won Koo 5. Ethical Considerations in the Conduct of Vaccine Trials in Developing Countries 49 Charles Weijer and Claudio F. Lanata 6. Vaccine Economics: From Candidates to Commercialized Products in the Developing World 57 Amie Batson, Piers Whitehead, and Sarah Glass 7. Development and Supply of Vaccines: An Industry Perspective 75 MichelGreco 8. Reaching Every Child—Achieving Equity in Global Immunization 89 R. Bruce Aylward, M. Birmingham, J. Lloyd, and B. Melgaard 9. A Paradigm for International Cooperation: The Global Alliance for Vaccines and Immunization (GAVI) and the Vaccine Fund 101 Lisa Jacobs, Jacques-Francois Martin, and Tore Godal 10. Economic Analyses of Vaccines and Vaccination Programs 107 Benjamin Schwartz and IsmaelOrtega-Sanchez Regulatory Issues 11. The Role of the Food and Drug Administration in Vaccine Testing and Licensure 117 Norman Baylor, Lydia A. Falk, and Karen Midthun 12. Developing Safe Vaccines 127 Leslie K. Ball, Robert Ball, and Bruce G. Gellin Eradication and Elimination Programs 13. Polio Eradication: Capturing the Full Potential of a Vaccine 145 R. Bruce Aylward, Rudolph Tangermann, Roland Sutter, and Stephen L. Cochi ix Basic Immunology Applied to Vaccine Development 14. Recent Advances in Immunology that Impact Vaccine Development 159 Marcelo B. Sztein 15. High-Throughput Informatics and In Vitro Assays for T-Cell Epitope Determination: Application to the Design of Epitope-Driven Vaccines 179 Anne S. DeGroot, Hakima Sbai, William Martin, John Sidney, Alessandro Sette, and Jay A. Berzofsky 16. The Challenge of Inducing Protection in Very Young Infants 197 Claire-Anne Siegrist 17. Vaccination and Autoimmunity 203 Paul-Henri Lambert and Michel Goldman Adjuvants, Immunopotentiation, and Nonliving Antigen Delivery Systems 18. Adjuvants for the Future 213 Richard T. Kenney and Robert Edelman 19. MF59 Adjuvant Emulsion 225 Audino Podda and Giuseppe DelGiudice 20. Immune-Enhancing Sequences (CpG Motifs), Cytokines, and Other Immunomodulatory Moieties 237 Sanjay Gurunathan, Dennis M. Klinman, and Robert A. Seder 21. Use of Genetically Detoxified Mutants of Cholera and Escherichia coli Heat-Labile Enterotoxins as Mucosal Adjuvants 251 Gordon Dougan and Gill Douce 22. Recent Developments in Vaccine Delivery Systems 259 Derek T. O’Hagan 23. Proteosomek Technology for Vaccines and Adjuvants 271 George H. Lowell, David Burt, Greg White, and Louis Fries 24. Viruslike Particle (VLP) Vaccines 283 Margaret E. Conner and Mary K. Estes 25. Immunostimulating Reconstituted Influenza Virosomes 295 Reinhard Glueck 26. Plants as a Production and Delivery Vehicle for Orally Delivered Subunit Vaccines 305 Tsafrir S. Mor, Hugh S. Mason, Dwayne D. Kirk, Charles J. Arntzen, and Guy A. Cardineau Live Vector Vaccines 27. Vaccinia Virus and Other Poxviruses as Live Vectors 313 Bernard Moss 28. Live Adenovirus Recombinants as Vaccine Vectors 325 L. Jean Patterson, Bo Peng, Xinli Nan, and Marjorie Robert-Guroff 29. RNA Virus Replicon Vaccines 337 Nancy L. Davis and Robert E. Johnston 30. Attenuated Salmonella and Shigella as Live Vectors Carrying Either Prokaryotic or Eukaryotic Expression Systems 353 James E. Galen, Marcela F. Pasetti, Marcelo B. Sztein, Eileen M. Barry, and Myron M. Levine Improving DNA Vaccines 31. DNA Vaccines 367 Indresh K. Srivastava, Margaret A. Liu, and Jeffrey B. Ulmer 32. DNA-Modified Virus Ankara and Other Heterologous Prime-Boost Immunization Strategies for Effector T Cell Induction 381 Adrian V. S. Hill, Joerg Schneider, and Andrew J. McMichael Nonparenteral Delivery of Vaccines and Infant Combination Vaccines 33. Mucosal Immunization and Needle-Free Injection Devices 393 Myron M. Levine and James D. Campbell 34. Transcutaneous Immunization 401 Gregory M. Glenn and Richard T. Kenney 35. Combination Vaccines for Routine Infant Immunization 413 Margaret B. Rennels, Rosanna M. Lagos, and Kathryn M. Edwards New and Improved Vaccines Against Diseases for Which There Already Exist Licensed Vaccines 36. Meningococcal Conjugate and Protein- Based Vaccines 421 Rino Rappuoli, Andrew J. Pollard, and E. Richard Moxon 37. The Postlicensure Impact of Haemophilus influenzae Type b and Serogroup C Neisseria meningitides x Contents Conjugate Vaccines 427 Jay Wenger, Helen Campbell, Elizabeth Miller, and David Salisbury 38. Pneumococcal Protein–Polysaccharide Conjugate Vaccines 443 Orin S. Levine, David L. Klein, and Jay C. Butler 39. Pneumococcal Common Proteins and Other Vaccine Strategies 459 David E. Briles, James C. Paton, and Susan K. Hollingshead 40. Polysaccharide-Based Conjugate Vaccines for Enteric Bacterial Infections: Typhoid Fever, Nontyphoidal Salmonellosis, Shigellosis, Cholera, and Escherichia coli 0157 471 Shousun C. Szu, John B. Robbins, RachelSchneerson, Vince Pozsgay, and Chiayung Chu 41. Attenuated Strains of Salmonella enterica serovar Typhi as Live Oral Vaccines Against Typhoid Fever 479 Myron M. Levine, James Galen, CarolO. Tacket, Eileen M. Barry, Marcela F. Pasetti, and Marcelo B. Sztein 42. Vaccines Against Lyme Disease 487 Mark S. Hanson and Robert Edelman 43. Oral B Subunit–Killed Whole-Cell Cholera Vaccine 499 Jan Holmgren and Charlotta Bergquist 44. Attenuated Vibrio cholerae Strains as Live Oral Cholera Vaccines and Vectors 511 James B. Kaper and CarolO. Tacket 45. Novel Vaccines Against Tuberculosis 519 Robert J. Wilkinson and Douglas B. Young 46. New Approaches to Influenza Vaccine 537 John J. Treanor, James C. King, and Kenneth M. Zangwill 47. Chimeric Vaccines Against Japanese Encephalitis, Dengue, and West Nile 559 Konstantin V. Pugachev, Thomas P. Monath, and Farshad Guirakhoo Vaccines Against Diseases for Which Licensed Vaccines Do Not Currently Exist (or That Have Not Been Widely Used) 48. Challenges and Current Strategies in the Development of HIV/AIDS Vaccines 573 Chad A. Womack, Margaret A. Liu, and Barney S. Graham 49. Vaccine Strategies to Prevent Dengue Fever 583 Niranjan Kanesa-thasan, J. Robert Putnak, and David W. Vaughn 50. Vaccination Against the Hepatitis C Viruses 593 MichaelHoughton and Sergio Abrignani 51. Live Vaccine Strategies to Prevent Rotavirus Disease 607 Richard L. Ward, H. Fred Clark, PaulA. Offit, and Roger I. Glass 52. Vaccines Against Respiratory Syncytial Virus and Parainfluenza Virus Types 1–3 621 James E. Crowe, Jr., Peter L. Collins, and Brian R. Murphy 53. Developing a Vaccine Against Epstein–Barr Virus 641 Denis Moss and Mandvi Bharadwaj 54. Cytomegalovirus Vaccines 649 David I. Bernstein and Stanley A. Plotkin 55. Herpes Simplex Vaccines 661 Richard J. Whitley 56. Vaccines for Hantaviruses, Lassa Virus, and Filoviruses 679 Connie Schmaljohn, Joseph B. McCormick, Gary J. Nabel, and Alan Schmaljohn 57. Development of a Vaccine to Prevent Infection with Group A Streptococci and Rheumatic Fever 695 MichaelF. Good, P. J. Cleary, James Dale, Vincent Fischetti, K. Fuchs, H. Sabharwal, and J. Zabriskie 58. Vaccines Against Group B Streptococcus 711 Morven S. Edwards, Lawrence C. Paoletti, and Carol J. Baker 59. Overview of Live Vaccine Strategies Against Shigella 723 Karen L. Kotloff, Thomas L. Hale, Eileen M. Barry, and Philippe Sansonetti 60. Oral Inactivated Whole Cell B Subunit Combination Vaccine Against Enterotoxigenic Escherichia coli 737 Ann-Mari L. Svennerholm and Stephen J. Savarino 61. Multivalent Shigella/Enterotoxigenic Escherichia coli Vaccine 751 Eileen M. Barry and Myron M. Levine Contents xi 62. Vaccines Against Gonococcal Infection 755 Timothy A. Mietzner, Christopher E. Thomas, Marcia M. Hobbs, and Myron S. Cohen 63. Vaccines Against Campylobacter jejuni 775 David R. Tribble, Shahida Baqar, and DanielA. Scott 64. Vaccines Against Uropathogenic Escherichia coli 787 Solomon Langermann and W. Ripley Ballou, Jr. 65. Vaccine Strategies Against Helicobacter pylori 795 Karen L. Kotloff, Cynthia K. Lee, and Giuseppe DelGiudice 66. Vaccines for Staphylococcus aureus Infections 807 Ali I. Fattom, Gary Horwith, and Robert Naso 67. Moraxella catarrhalis and Nontypable Haemophilus influenzae Vaccines to Prevent Otitis Media 817 Philippe A. Denoel, Fabrice Godfroid, Joelle Thonnard, Ce´cile Neyt, David W. Dyer, and Jan T. Poolman 68. Vaccines for Chlamydia trachomatis and Chlamydia pneumoniae 835 Andrew D. Murdin and Robert C. Brunham 69. Overview of Vaccine Strategies for Malaria 847 MichaelF. Good and David Kemp 70. Adjuvanted RTS,S and Other Protein-Based Pre-Erythrocytic Stage Malaria Vaccines 851 D. Gray Heppner, Jr., James F. Cummings, Joe D. Cohen, W. Ripley Ballou, Jr., Christian F. Ockenhouse, and Kent E. Kester 71. Malaria: A Complex Disease that May Require A Complex Vaccine 861 Stephen L. Hoffman, Denise L. Doolan, and Thomas L. Richie 72. Plasmodium falciparum Asexual Blood Stage Vaccine Candidates: Current Status 875 Danielle I. Stanisic, Laura B. Martin, Robin F. Anders, and MichaelF. Good 73. Malaria Transmission-Blocking Vaccines 887 Allan Saul 74. Vaccines Against Leishmania 903 Farrokh Modabber, Steven G. Reed, and Antonio Campos-Neto 75. Vaccines Against Schistosomiasis 915 Andre´ Capron, Gilles J. Riveau, Paul B. Bartley, and Donald P. McManus 76. Vaccines Against Entamoeba histolytica 927 Christopher D. Huston and William A. Petri, Jr. 77. Vaccines Against Human Hookworm Disease 937 Peter J. Hotez, Zhan Bin, Alex Loukas, Jeff M. Bethony, James Ashcom, Kashinath Ghosh, John M. Hawdon, Walter Brandt, and Philip K. Russell Vaccines Against Cancer and Other Chronic Diseases and Vaccine Therapy 78. Principles of Therapeutic Vaccination for Viral and Nonviral Malignancies 953 Drew M. Pardoll 79. Vaccines Against Human Papillomavirus Infection 977 John Boslego, Xiaosong Liu, and Ian H. Frazer 80. Active Immunization with Dendritic Cells Bearing Melanoma Antigens 987 Ralph M. Steinman, Karolina Palucka, Jacques Banchereau, Beatrice Schuler-Thurner, and Gerold Schuler 81. Vaccine Against Alzheimer’s Disease 995 Roy M. Robins-Browne, Richard A. Strugnell, and Colin L. Masters 82. Vaccines Against Atherosclerosis 1003 CarlR. Alving 83. Vaccine Therapy 1011 Donald S. Burke 84. Vaccination-Based Therapies in Multiple Sclerosis 1025 Jacqueline Shukaliak-Quandt and Roland Martin 85. Vaccine Therapy for Autoimmune Diabetes 1041 Irun R. Cohen 86. Vaccines for the Treatment of Autoimmune Diseases 1047 David C. Wraith 87. Vaccines to Treat Drug Addiction 1057 PaulR. Penteland Dan E. Keyler xii Contents Vaccines Against Bioterror Agents 88. Vaccines Against Agents of Bioterrorism 1067 Theodore J. Cieslak, Mark G. Kortepeter, and Edward M. Eitzen, Jr. 89. A Primer on Large-Scale Manufacture of Modern Vaccines 1081 Julie B. Milstien, Jean Ste´phenne, and Lance Gordon 90. Heterogeneity of Pediatric Immunization Schedules in Industrialized Countries 1093 James D. Campbell and Margaret Burgess Index 1097