The Vaccine Book

2nd Edition - June 23, 2016
Editors: Barry R. Bloom, Paul-Henri Lambert
Language: English
Paperback ISBN:
9 7 8 - 0 - 1 2 - 8 0 2 1 7 4 - 3
eBook ISBN:
9 7 8 - 0 - 1 2 - 8 0 5 4 0 0 - 0

The Vaccine Book, Second Edition provides comprehensive information on the current and future state of vaccines. It reveals the scientific opportunities and potential impact of… Read more

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The Vaccine Book, Second Edition provides comprehensive information on the current and future state of vaccines. It reveals the scientific opportunities and potential impact of vaccines, including economic and ethical challenges, problems encountered when producing vaccines, how clinical vaccine trials are designed, and how to introduce vaccines into widespread use.

Although vaccines are now available for many diseases, there are still challenges ahead for major diseases, such as AIDS, tuberculosis, and malaria. This book is designed for students, researchers, public health officials, and all others interested in increasing their understanding of vaccines. It answers common questions regarding the use of vaccines in the context of a rapidly expanding anti-vaccine environment.

This new edition is completely updated and revised with new and unique topics, including new vaccines, problems of declining immunization rates, trust in vaccines, the vaccine hesitancy, and the social value of vaccines for the community vs. the individual child’s risk.

Dedication
Contributors
Preface
Introduction-Global Burden of Disease addressed by Current Vaccines and Vaccines in the Development Pipeline
Part I: Understanding Vaccine Impact at Population and Individual Levels
- Chapter 1: The Impact of Vaccination on the Epidemiology of Infectious Diseases
  - Abstract
  - 1. Introduction
  - 2. Changing world
  - 3. Basic epidemiological principles
  - 4. Vaccine coverage required to interrupt transmission
  - 5. A shifting average age at infection
  - 6. Perverse effects of vaccination
  - 7. Troughs in herd immunity as a consequence of the introduction of cohort based vaccination
  - 8. Indirect and direct effects of vaccination—benefits of herd immunity
  - 9. Health economics—costs and benefits of vaccination
  - 10. Partially effective vaccines—efficacy versus duration of protection
  - 11. Spatial and other heterogeneities
  - 12. Natural selection and mass vaccination
  - 13. Discussion
- Chapter 2: How Vaccines Work
  - Abstract
  - 1. Introduction
  - 2. What follows a vaccine injection? Basis of antibody response to protein vaccines
  - 3. Vaccine antigen recognition
  - 4. Germinal center reaction
  - 5. Building B-cell memory
  - 6. Response to polysaccharide vaccines
  - 7. Vaccine-induced T-cell responses
  - 8. Innate immunity and T-cell differentiation
  - 9. Vaccine-induced T-cell memory
  - 10. Conclusions
Part II: How to Design, Assess and Produce Vaccines
- Chapter 3: Vaccine Design in the 21st Century
  - Abstract
  - 1. Introduction
  - 2. Strategies for modern vaccine design
  - 3. Conclusions and future outlook
  - Acknowledgments
- Chapter 4: Vaccine Adjuvants
  - Abstract
  - 1. Brief adjuvant history
  - 2. Adjuvants in current approved vaccines
  - 3. Adjuvant development
  - 4. Mechanisms of action
  - 5. Formulation
  - 6. Adjuvants for unmet needs; HIV and tuberculosis vaccines
- Chapter 5: Vaccine Production: Main Steps and Considerations
  - Abstract
  - 1. Manufacturing basics
  - 2. Considerations for manufacturing vaccines
  - 3. Vaccine challenges from the industry perspective
  - 4. Manufacturing dilemmas
  - Acknowledgments
- Chapter 6: How are Vaccines Assessed in Clinical Trials?
  - Summary
  - 1. The vaccine testing paradigm
  - 2. Ethical issues
  - 3. Good Clinical Practices
  - 4. Phase 1
  - 5. Phase 2
  - 6. Phase 3
  - 7. Issues to be considered in designing a Phase 3 vaccine efficacy trial
  - 8. Phase 4 surveillance and studies to monitor product safety and the impact on disease burden with vaccine use post-licensure
  - 9. Summary note
- Chapter 7: Immunological Correlates of Vaccine-Mediated Protection
  - Abstract
  - 1. Introduction
  - 2. Definitions
  - 3. Indentifying correlates of protection
  - 4. Statistical methods for evaluating correlates of protection
  - 5. Correlates of protection as effector or pathway correlates
  - 6. Known correlates of protection for vaccines
  - 7. Conclusions
Part III: Vaccine Safety
- Chapter 8: How Vaccine Safety is Monitored
  - Abstract
  - 1. Introduction
  - 2. Vaccine development
  - 3. Investigational new drug (IND) application
  - 4. Clinical trials
  - 5. Regulatory approval
  - 6. Vaccine recommendations
  - 7. Postmarketing surveillance and special studies
  - 8. Standardized case definitions
  - 9. Clinical assessment and individual-level causality assessment
  - 10. Compensation for vaccine injuries
  - 11. Coordination
  - 12. Investigations of reports of MMR and autism: an example
  - 13. Summary
- Chapter 9: Vaccination and Autoimmune Diseases
  - Abstract
  - 1. Introduction
  - 2. Understanding infection-associated autoimmunity
  - 3. The risk of vaccine-associated autoimmunity
  - 4. Vaccine-attributable autoimmune diseases
  - 5. Allegations of autoimmune adverse effects
  - 6. New generation vaccines and autoimmunity: approaches toward early risk assessment
  - 7. Vaccination in patients with chronic autoimmune diseases
  - 8. Conclusions
Part IV: New Vaccination Strategies
- Chapter 10: Maternal Immunization: Protecting Vulnerable Populations
  - Abstract
  - 1. Introduction
  - 2. Background
  - 3. Vaccines currently administered to pregnant women
  - 4. Potential maternal vaccines
  - 5. Safety of maternal immunization
  - 6. Potential obstacles for maternal immunization
  - 7. Clinical trial designs
  - 8. Social and ethical issues
  - 9. Summary
- Chapter 11: New Challenges for Pertussis Vaccines
  - Abstract
  - 1. Historical perspective
  - 2. Changing epidemiology
  - 3. Current use of pertussis vaccines
  - 4. Relative merits of acellular and whole-cell pertussis vaccines
  - 5. Remaining gaps in control of pertussis
  - 6. Prospects for new pertussis vaccines
  - 7. Interim measures for the control of pertussis
  - 8. Summary and conclusions
Part V: Recently Introduced Vaccines
- Chapter 12: Pneumococcus, Pneumococcal Disease, and Prevention
  - Abstract
  - 1. Introduction
  - 2. The organism and associated pathology
  - 3. Epidemiology of pneumococcal disease
  - 4. Immunology
  - 5. Vaccines against pneumococcus
  - 6. Future vaccine approaches
  - 7. Conclusions
- Chapter 13: Human Papillomavirus Vaccines
  - Abstract
  - 1. Introduction
  - 2. Burden of HPV-associated disease
  - 3. HPV vaccines: rationale
  - 4. Licensed prophylactic HPV vaccines
  - 5. Vaccine efficacy
  - 6. Implementation and effectiveness
  - 7. Vaccine impact
  - 8. Vaccine-induced immune responses
  - 9. Safety
  - 10. Alternative dosage schedules
  - 11. Concluding remarks
- Chapter 14: Rotavirus Vaccines
  - Abstract
  - 1. Biology of rotavirus
  - 2. Rotavirus disease and treatment
  - 3. Burden and epidemiology of rotavirus
  - 4. Rationale for rotavirus vaccine development
  - 5. The first licensed rotavirus vaccine—Rotashield
  - 6. Current internationally licensed rotavirus vaccines—Rotarix™ and RotaTeq
  - 7. Remaining issues and challenges for rotavirus vaccines
  - 8. Conclusions
  - Disclaimer
Part VI: New Approaches for Needed Vaccines
- Chapter 15: Antiviral Vaccines: Challenges and Advances
  - Abstract
  - 1. Introduction
  - 2. Types of currently licensed antiviral vaccines
  - 3. How antiviral vaccines mediate protection?
  - 4. Modern approaches to studying immune responses induced by antiviral vaccines
  - 5. Next generation vaccine platforms
  - 6. Harnessing the technological advances to develop vaccines against challenging and emerging viruses
  - 7. Summary
  - Acknowledgments
- Chapter 16: New Approaches for Needed Vaccines: Bacteria
  - Abstract
  - 1. Background
  - 2. Gaps and targets
  - 3. Classical approaches for making bacterial vaccines
  - 4. The impact of genomics on bacterial vaccine development
  - 5. Reverse vaccinology
  - 6. Live vaccines against bacteria
  - 7. Vaccines based on membrane complexes
  - 8. Killed oral vaccines
  - 9. Bioconjugates
  - 10. Concluding remarks
  - Acknowledgment
- Chapter 17: Vaccines Against Parasites
  - Abstract
  - 1. Vaccination against malaria
  - 2. Vaccination against leishmaniasis
  - 3. Vaccination against helminths
Part VII: Major Global Vaccine Challenges
- Chapter 18: Tuberculosis Vaccines
  - Abstract
  - 1. Introduction
  - 2. Tuberculosis
  - 3. The current TB vaccine – BCG
  - 4. New strategies toward vaccination against TB
  - Acknowledgments
- Chapter 19: Major Global Vaccine Challenges: Recent Progress in Malaria Vaccine Development
  - Abstract
  - 1. Introduction
  - 2. Preerythrocytic vaccine candidates
  - 3. Blood-stage vaccine candidates
  - 4. Sexual stage vaccine candidates
  - 5. Multiple-stage vaccine candidates
  - 6. Vaccine candidates against malaria in pregnancy
  - 7. P. vivax vaccine development status
  - 8. Conclusions
  - Acknowledgment
- Chapter 20: AIDS Vaccines
  - Abstract
  - 1. Introduction
  - 2. Immune responses to HIV: what is needed?
  - 3. Efficacy trials of candidate vaccines
  - 4. Planned efficacy trials of candidate HIV vaccines
  - 5. New HIV vaccine concepts on the horizon
  - 6. Vaccines and the HIV cure agenda
  - 7. Conclusions
- Chapter 21: Influenza Vaccines and Vaccination Strategies
  - Abstract
  - 1. Introduction
  - 2. The influenza virus
  - 3. Influenza disease and burden of illness
  - 4. Influenza vaccines
  - 5. Non-replicating influenza vaccines
  - 6. Safety of non-replicating vaccines
  - 7. Immunogenicity of inactivated vaccines
  - 8. Efficacy and effectiveness
  - 9. Populations of interest
  - 10. Live-attenuated influenza vaccines (LAIVs)
  - 11. Immunogenicity
  - 12. Safety
  - 13. Efficacy and effectiveness
  - 14. Influenza vaccines in development
  - 15. Vaccination policy and programs
  - 16. Challenges of influenza vaccine programs in low resource settings
  - 17. Summary
Part VIII: Ethical Considerations
- Chapter 22: Ethical Considerations in Vaccine Trials in Resource-Limited Settings
  - Abstract
  - 1. Introduction
  - 2. Ethical considerations
  - 3. Conclusions
  - Acknowledgment
Part IX: Vaccine Economics
- Chapter 23: Economic Considerations for the Development of Global Vaccines: a Perspective From the Vaccine Industry
  - Abstract
  - 1. Program valuation and portfolio management
  - 2. Conclusions
- Chapter 24: Introduction of Vaccines Into National Programs
  - Abstract
  - 1. Introduction
  - 2. Political considerations
  - 3. Natural history and epidemiologic considerations
  - 4. Regulatory considerations
  - 5. Program Considerations
  - 6. Economic considerations
  - 7. Financing
  - 8. Modeling the impact-efficiency or opportunity costs
  - 9. Global efforts to support vaccines introduction
- Chapter 25: Transitioning Immunization Into the Health Care System: Strengthening Routine Immunization in India
  - Abstract
  - 1. Introduction
  - 2. Background: India’s Universal Immunization Programme
  - 3. Improving coverage
  - 4. New vaccine introduction
  - 5. Health system strengthening
  - 6. Conclusions
Part X: Trust in Vaccines
- Chapter 26: Vaccine Acceptance
  - Abstract
  - 1. Introduction
  - 2. From vaccine hesitancy to vaccine demand: Making sense of terminology and concepts
  - 3. Determinants of vaccine hesitancy, drivers of vaccine acceptance
  - 4. Vaccination decisions and risk perception
  - 5. Communication about vaccination and risk perception
  - 6. Conclusions
- Chapter 27: Trust and Confidence in Vaccines: Tales of Three Vaccines, Lessons for Others
  - Abstract
  - 1. Three case studies of vaccine hesitancy and distrust
  - 2. Lessons learned
  - 3. The need for evidence-based recommendations for the future
  - Acknowledgment
Part XI: Future Challenges
- Chapter 28: Vaccines for Emerging Viral Diseases
  - Abstract
  - 1. Introduction
  - 2. Ebola
  - 3. Chikungunya
  - 4. Middle East Respiratory Syndrome Coronavirus
  - 5. Conclusions
  - Acknowledgments
- Chapter 29: Cancer Immunotherapy by Checkpoint Blockade
  - Abstract
  - 1. Introduction
  - 2. Cancer immunotherapy
  - 3. Regulation of immune responses
  - 4. Applications for cancer therapy
  - 5. Application for infectious diseases
  - 6. Summary and future perspectives
- Chapter 30: Adoptive Cellular Therapy With Synthetic T Cells as an “Instant Vaccine” for Cancer and Immunity
  - Abstract
  - 1. Introduction
  - 2. Discovery of T cells with stem-cell-like qualities
  - 3. Approaches to engineer lymphocytes using synthetic biology
  - 4. Design of CAR T cells
  - 5. Lessons from clinical trials on patients with chronic infection
  - 6. Clinical trials with CAR T cells directed against B-cell malignancies
  - 7. Toxicities and management
  - 8. Conclusions and future challenges
Subject Index

Barry R. Bloom

Dr. Bloom is Harvard University's Distinguished Service Professor of the Department of Immunology and Infectious Diseases and Former Dean of the Harvard School of Public Health. He received a bachelor’s degree and an honorary Sc.D. from Amherst College, and a Ph.D. from Rockefeller University. He is widely recognized for his work in the area of cell-mediated immunity, infectious diseases, particularly tuberculosis and leprosy, and global health. The discovery of lymphocyte-produced cytokines and the development of genetic systems in mycobacteria are among his scientific contributions. He has published over 300 papers and edited 4 books. He served as a consultant to the White House on International Health Policy, was elected President of the American Association of Immunologists, and served as President of the Federation of American Societies for Experimental Biology.

Dr. Bloom has been extensively involved with the World Health Organization (WHO) for more than 40 years. He was a member of the WHO Advisory Committee on Health Research (ACHR) and chaired the WHO Committees on Immunology of Leprosy (IMMLEP), Immunology of Tuberculosis (IMMTUB), the Scientific and Technical Advisory Committee of the UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (STAC) and chaired the WHO Global Malaria Programme. He was first chair of the Board of Trustees of the International Vaccine Institute, Seoul, Korea. He as served on the National Advisory Councils of the U.S. National Institute of Allergy and Infectious Diseases, NIH, and the Center for Infectious Diseases, of the US Centers for Disease Control and Prevention. He currently serves on the scientific advisory boards of the Wellcome Trust Centre for Human Genetics, K-RITH, and Human Heredity and Health in Africa (H3Africa). He has received numerous awards for his scientific work including the first Bristol-Myers Award in Infectious Diseases, the Robert Koch Gold Medal for lifetime achievement in research, and shared the Novartis Award in Immunology. He was elected to membership of the U.S. National Academy of Sciences, the National Academy of Medicine, the American Academy of Arts and Sciences and the American Philosophical Society.

Affiliations and expertise

Harvard University Distinguished Service Professor and Joan and Jack Jacobson Professor of Public Health, Harvard School of Public Health, Boston, MA, USA

Paul-Henri Lambert

Paul-Henri Lambert, MD, is now associated with the Centre of Vaccinology in the Department of Pathology and Immunology at University of Geneva. He is particularly interested in vaccination strategies and evaluation of adverse effects. He is directing the International Advanced Course of Vaccinology (ADVAC) organized under the auspices of the Fondation Mérieux and University of Geneva. He is a member of the Governing Board of the Tuberculosis Vaccine Initiative (TBVI) and past-chairman of the Human Vaccine Committee of the International Association for Biologicals (IABS) and of the WHO GACVS (Global Advisory Committee on Vaccine Safety). Paul Henri Lambert is a native of Belgium where he was boarded in Internal Medicine (University of Liege). He joined Frank Dixon at Scripps Institute, La Jolla, California, for his training then moved to University of Geneva Medical School where he became professor in the Departments of Medicine and of Pathology. His research activities lead him to decipher immunological mechanisms involved in autoimmune and immune complex-mediated diseases, in the pathogenesis of malaria and in new strategies to optimize vaccine immunogenicity. In 1987, he was appointed as chief Microbiology and Immunology at the World Health Organization and in 1994, Chief, Vaccine Research and Development, WHO Global Program for Vaccines and Immunization. He was then deeply involved in co-ordination of research aiming at the development of vaccines against diseases of major importance in developing countries. Paul-Henri Lambert is author or co-author of 436 publications, member of several international scientific boards, foreign member of the Royal Academy of Medicine in Belgium and Fellow of the American Association for the Advancement of Science.

Affiliations and expertise

Professor, Centre of Vaccinology, University of Geneva, Switzerland