Vaccines 6/e

Apply the latest vaccination knowledge with a reference that Bill Gates calls "an indispensable guide to the
enhancement of the well-being of our world." Inside Vaccines, you'll find comprehensive and current coverage of every
aspect of vaccination, from the development of each vaccine to its use in reducing disease. This medical reference book
offers the expert information you need to apply the very latest techniques and information in your practice!

Table of Contents
Instructions for online access
Title page
Copyright
Foreword
Preface to the first edition
Preface to the sixth edition
Preface by Editor in Chief
List of Contributors
Dedication
Acknowledgements
Section 1: General aspects of vaccination
Chapter 1: A short history of vaccination
Early developments
First half of the 20th century
Second half of the 20th century
Polio wars
Other live virus vaccines
Live bacterial vaccine
Whole-virus vaccines
Vaccines based on bacterial proteins, polysaccharides, and protein-conjugated polysaccharides
Recombinant protein vaccines
Chapter 2: Vaccine immunology
How do vaccines mediate protection?
From innate to adaptive immunity activation: the first steps after immunization
Vaccine antibody responses
Chapter 3: The vaccine industry
Vaccine development
Role of partners
Funding sources for vaccine research and development
Pricing of vaccines
Acknowledgments
Chapter 4: Vaccine manufacturing
Manufacturing basics
Examples of vaccine production
Product development
Current GMP considerations
Analytical testing
Industry’s response to new challenges
Chapter 5: Evolution of adjuvants across the centuries
Chance and necessity: The discovery of adjuvants
A turning point: Better understanding of immunology and its impact on development of adjuvants
Defining adjuvants: Classification and evaluation
Future directions
Acknowledgment
Chapter 6: Vaccine additives and manufacturing residuals in the United States: licensed vaccines
Vaccine additives
Manufacturing residuals
Sensitizing substances
Summary
Chapter 7: Passive immunization
Passive immunity―general considerations
Bacterial diseases
Serious bacterial infections
Viral infections
Chapter 8: General immunization practices
Vaccine storage and handling
Vaccine administration
Alleviation of pain and discomfort associated with vaccination
Ages for administration of immunobiologics
Spacing of vaccine doses
Simultaneous administration of different vaccines
Interference by immune globulins
Recommendations for spacing administration of vaccines and immune globulins
Interchangeability of vaccines from different manufacturers
Hypersensitivity to vaccine components
Vaccine components causing hypersensitivity
Management of acute vaccine adverse reactions
Special considerations
Breastfeeding and immunization
Vaccination during pregnancy
Vaccination of household contacts
Vaccines received outside the United States
Vaccination of persons with a personal or family history of seizures
Vaccination during acute illness
Contraindications to and precautions regarding vaccination
Section 2: Licensed vaccines
Chapter 9: Adenovirus vaccines
History of disease
Why the disease is important
Background
Epidemiology
Passive immunization
Active immunization
Immunogenicity of vaccine
Efficacy and effectiveness of vaccine
Indications for vaccine―who and why
Contraindications and precautions
Public health considerations
Future vaccine
Acknowledgments
Chapter 10: Anthrax vaccines
Background
Epidemiology
Passive immunization
Active immunization
Public health considerations
Future vaccines
Chapter 11: Cholera vaccines
History of disease
Why the disease is important
Clinical description and complications
Bacteriology
Pathogenesis as it relates to prevention
Modes of transmission
Diagnosis
Case management
Epidemiology
Passive immunization
Active immunization
Future vaccines
Acknowledgement
Chapter 12: Diphtheria toxoid
History of the disease
Clinical description
Bacteriology
Pathogenesis as it relates to prevention
Diagnosis
Treatment and prevention with antimicrobials
Epidemiology
Passive immunization
Treatment of diphtheria
Active immunization
Public health considerations
Eradication
Future vaccines
Chapter 13: Haemophilus influenzae vaccines
History
Background (Box 13-1)
Epidemiology in the prevaccine era (Box 13-2)
Passive immunization
Active immunization (Box 13-3)
The postvaccine era: Public health considerations
Future vaccines
Chapter 14: Hepatitis A vaccines
Why the disease is important
Background
Epidemiology
Modes of transmission
Significance as a public health problem
Passive immunization
Active immunization
Public health considerations
Eradication or elimination
Future vaccines
Acknowledgment
Chapter 15: Hepatitis B vaccines
Background
Burden and Epidemiology
Passive immunization
Active immunization
Results of vaccination
Indications and goals for Hepatitis B Vaccination
Maternal hepatitis B surface antigen (HBsAg) testing
Vaccination of infants
Vaccination of children and adolescents
Persons at risk for infection by sexual exposure
Persons at risk for infection by percutaneous or mucosal exposure to blood
Others
Contraindications
Public health considerations and impact of worldwide hepatitis B vaccination programs
Future vaccines
Chapter 16: Human papillomavirus vaccines
Clinical description
Virology
Pathogenesis
Epidemiology and transmission
Diagnosis
Prophylactic vaccines
Current vaccines
Immunogenicity bridging trials
Mechanism of protection
Duration of protection
Indications
Recommended schedule
Precautions and contraindications
Postlicensure vaccine safety evaluations
Cervical cancer screening among vaccinated females
Vaccine introduction
Postlicensure monitoring and impact of vaccination
Second-generation prophylactic vaccines
Therapeutic vaccines
Why therapeutic HPV vaccines have had modest success
Chapter 17: Inactivated influenza vaccines
Background
Epidemiology
Active immunization
Immune responses to vaccination and correlates of protection
Efficacy and effectiveness of vaccine
Safety
Indications for vaccine
Other directions for influenza virus vaccines
Public health considerations
Chapter 18: Influenza vaccine―live
Why the disease is important
Influenza
Virology
Pathogenesis as it relates to prevention
Live attenuated vaccines
History and development of cold-adapted intranasal live attenuated vaccine
Reverse genetics
Characteristics and formulations of LAIV
Immune correlates of protection for LAIV
Live attenuated vaccines against pandemic influenza
Transmission of LAIV
Indications for use of LAIV to prevent influenza
Special Considerations and Contraindications
Timing of LAIV administration
Conclusions
Acknowledgment
Chapter 19: Japanese encephalitis vaccines
History of disease
Why the disease is important
Background
Chapter 20: Measles vaccine
Background
Epidemiology
Passive immunization
Active immunization
Results of vaccination
Future vaccines
Public health considerations
Acknowledgment
Chapter 21: Meningococcal vaccines
Importance of meningococcal disease
Background
Case confirmation
Treatment and prevention
Epidemiology
Meningococcal immunity
Polysaccharide meningococcal vaccines: composition, immunogenicity, limitations, efficacy, and safety
Meningococcal polysaccharide-protein conjugate vaccines
Multivalent meningococcal conjugate vaccines
Recommendations for the use of meningococcal vaccines in the United States
Meningococcal vaccines in Canada
Meningococcal vaccine policy in Europe
A meningococcal capsular group A conjugate vaccine for Africa
Group B vaccine development
Acknowledgments
Chapter 22: Mumps vaccine
Background
Virology
Pathogenesis as it relates to prevention
Humoral and cell-mediated responses to natural infection
Diagnosis
Correlates of immunity
Epidemiology
Passive immunization
Active immunization
Stability of vaccine
Combinations including mumps vaccine
Results of vaccination
Cellular immune responses to vaccination
Factors influencing seroconversion
Persistence of antibodies
Immunocompromised persons
Protective efficacy in controlled clinical trials
Effectiveness in field use and duration of immunity
Risk factors for vaccine failure and recent outbreaks
Transmission of vaccine virus
Possibility of herd immunity
Simultaneous administration with other vaccines
Adverse events
Indications for vaccination
Precautions and contraindications
Public health considerations
Disease control strategies and possible eradication
Chapter 23: Pertussis vaccines
History of disease
Why the disease is important
Clinical description
Bacteriology
Pathogenesis of pertussis
Diagnosis
Treatment and prevention with antibiotics
Epidemiology
Passive immunization
Active immunization
Results of vaccination: whole-cell pertussis vaccines
Results of vaccination: acellular pertussis vaccines
Indications for vaccine
Public health considerations
Chapter 24: Plague vaccines
Clinical description
Bacteriology
Pathogenesis
Models of disease and protection
Diagnosis of plague
Treatment and prevention with antimicrobials
Epidemiology
Passive immunization
Active immunization
Results of vaccination
Indications for vaccine use
Persistence of immunity
Safety
Future developments
Chapter 25: Pneumococcal conjugate vaccine and pneumococcal common protein vaccines
Introduction
Pathogenesis
Background
Epidemiology
History of vaccine development and vaccine formulations
Immunogenicity
Efficacy and effectiveness
Safety
Public health considerations
Future vaccines
Chapter 26: Pneumococcal polysaccharide vaccines
Introduction
Background
Epidemiology of pneumococcal infections
Passive immunization
Active immunization with pneumococcal polysaccharide vaccine
Immunogenicity of vaccine
Vaccine efficacy and effectiveness
Vaccine safety
Indications for vaccine
Contraindications and precautions
Public health considerations
Chapter 27: Poliovirus vaccine―inactivated
Historical introduction
Passive immunization
Active immunization
Contraindications to IPV
Public health considerations
Chapter 28: Poliovirus vaccine―live
Why is the disease important?
Background
Virology
Pathogenesis as it relates to prevention
Diagnosis
Epidemiology
Passive immunization
Active immunity
Results of vaccination
Public health considerations
Conclusion
Chapter 29: Rabies vaccines
Historical perspective
Clinical description
Virology
Pathogenesis as it relates to prevention
Diagnosis
Epizootiology and epidemiology
Nonbite transmission
Human rabies
Passive immunization
Active immunization
Cell culture rabies vaccines
Immunization schedules
Serum and vaccine prophylaxis
Results of immunization
Persistence of immunity and booster doses
Vaccination of immunosuppressed persons
Protection against lyssaviruses other than genotype 1
Correlates of immunoprotection
Treatment failures
Adverse reactions
Indications for vaccination
Contraindications to vaccination
Public health considerations
The “fourth-generation” rabies vaccines
Monoclonal antibodies
Conclusions
Chapter 30: Rotavirus vaccines
Clinical disease
Passive immunization
Active immunization
Recommendations for use of RotaTeq and Rotarix
Acknowledgements
Chapter 31: Rubella vaccine
Rubella
Background
Epidemiology
Passive immunization
Active immunization
Public health considerations
The future
Chapter 32: Smallpox and vaccinia
Early history of smallpox disease
Development of the smallpox vaccine
Smallpox eradication
Significance as a public health problem―why the disease is important
Background
Epidemiology
Passive immunization and vaccinia immune globulin
Active immunization
Immunogenicity and results of vaccination
Duration of immunity and protection, including description of reinfection
Postexposure prophylaxis and therapeutic vaccination
Safety and adverse events
Indications for vaccine―who and why
Contraindications and precautions
Future vaccines
Destruction of the virus
Chapter 33: Tetanus toxoid
Clinical description
Bacteriology
Pathogenesis
Diagnosis
Treatment
Epidemiology
Natural immunity
Passive immunization
Active immunization: toxoid
Results of active immunization
Indications for use
Duration of immunity
Booster immunization for prevention of maternal and neonatal tetanus
Immunization in immunodeficiency
Adverse events after immunization
Tetanus prophylaxis in wound management
Public health perspective
Chapter 34: Tick-borne encephalitis virus vaccines
Background
Epidemiology
Passive immunization
Active immunization
Vaccine immunogenicity
Comparative studies
Duration of immunity and protection
Efficacy and effectiveness of vaccine
Public health considerations
Future vaccines
Acknowledgments
Chapter 35: Tuberculosis vaccines
Human tuberculosis: a brief history
Clinical description
Complications
Bacteriology
Pathogenesis as it relates to prevention
Diagnosis
Increased risk of exposure to an infectious adult
Increased risk of disease occurring after infection
Treatment and prevention with antibiotics
Epidemiology
Active immunization with bacille Calmette-GuIJrin
Public health considerations
Future vaccines for tuberculosis
Chapter 36: Typhoid fever vaccines
History of the disease
Why typhoid fever is important
Clinical description of typhoid fever
Complications of typhoid fever
Bacteriology
Pathogenesis
Diagnosis
Treatment with antimicrobials
Epidemiology
Risk groups
Modes of transmission and reservoirs of infection
Passive immunization
Active immunization
Vaccine constituents
Manufacture
Dosage and route
Vaccine stability
Immunogenicity
Efficacy and effectiveness of typhoid vaccines
Public health aspects
Future vaccines
Chapter 37: Varicella vaccine
Historical aspects
Clinical description
Virology
Pathogenesis as it relates to prevention
Immune responses to VZV
Diagnosis
Treatment and prophylaxis
Epidemiology
Passive immunization
Active immunization: the Oka vaccine strain
The VZV vaccine in healthy children
VZV vaccine in adolescents and adults
Immunocompromised patients
Vaccine Adverse Events
Indications for vaccination
Routine childhood schedule
Persons ◎ 13 years
Public health considerations
Potential for elimination of endemic disease transmission and eradication
Acknowledgments
Chapter 38: Yellow fever vaccine
History
Background
Pathogenesis
Innate and adaptive immune responses 쭯 general considerations
Diagnosis
Treatment
Epidemiology
Passive immunization and passive-active immunization
Inactivated vaccines
Live vaccines
Results of vaccination
Primary vaccine failure
Adverse events
Indications and contraindications for vaccination
Simultaneous and combined vaccination
Future yellow fever vaccines and yellow fever쭯vectored vaccines
Public health considerations
Chapter 39: Zoster vaccine
Pathogenesis
Clinical manifestations
Epidemiology
Treatment
Passive immunization
Active immunization
Indications
Contraindications
Concomitant administration
Public health considerations
Other considerations
Chapter 40: Combination vaccines
Terminology
Principles of combined vaccines
Combinations based on DTwP (or its components)
Combinations based on acellular pertussis vaccine
Combinations based on hepatitis vaccine, without DTP or DTaP
Combinations based on MMR vaccine
Combinations of Hib, meningococcal, or pneumococcal conjugate vaccines
Future combination vaccines
Practical issues in the use of combination vaccines
Public health considerations
Section 3: Vaccines in development and new vaccine strategies
Chapter 41: Biodefense and special pathogen vaccines
Limited-use vaccines against viral diseases
Limited-use vaccines against bacterial diseases
Acknowledgments
Chapter 42: Therapeutic cancer vaccines
Principles for developing cancer vaccines
Unique problems for cancer vaccines and strategies to overcome them
Immunologic monitoring
Cancer vaccines
Future for cancer vaccines
Chapter 43: Cytomegalovirus vaccines
Correlates of CMV immunity: implications for vaccine design
Vaccines in clinical trials
Subunit vaccine
Vectored vaccines
DNA gB, pp65, and IE1 vaccines
Future prospects: CMV vaccine approaches in preclinical development
Chapter 44: Dengue vaccines
Dengue viruses and dengue disease
Developing dengue vaccines
Vaccines in development
Live attenuated virus vaccines
Vectored vaccines
Replication-defective vaccines
Nucleic acid쭯based vaccines
Conclusions
Chapter 45: Diarrhea caused by bacteria
Shiga toxin쭯producing Escherichia coli (STEC)
Enterotoxigenic E. coli
Shigella species
Campylobacter jejuni
Chapter 46: Ebola vaccine
Background
Epidemiology
Postexposure treatments
Description of current vaccine and history of development
Immunogenicity of vaccine
Efficacy of vaccine
Duration of immunity
Safety
Public health considerations
Acknowledgments
Chapter 47: Epstein-Barr virus vaccines
Biology and immunology of EBV relevant to vaccine formulations
Positive and negative influences in EBV vaccine formulations
Transition from animal models to experimental vaccines
Vaccines for IM, PTLD, and XLP
Vaccines for NPC and HL
The role of adoptive immunotherapy
Integration of immunotherapy and conventional clinical control protocols
Conclusions
Chapter 48: Hepatitis C vaccines
Virology
HCV infection
Epidemiology
Immune response to HCV
Protective immunity against HCV
Strategies for an HCV vaccine
Future directions
Chapter 49: Hepatitis E vaccines
Clinical description
Virology and pathogenesis
Diagnosis
Treatment
Epidemiology
Passive immunization
Active immunization
Preclinical trials: safety, immunogenicity, and efficacy
Clinical trials: safety and immunogenicity
Clinical trials: safety, immunogenicity, and efficacy
Prospects for the future
Chapter 50: Herpes simplex virus vaccines
Background
Epidemiology
Active immunization
Chapter 51: Human immunodeficiency virus vaccines
Virology
Virus-cell interactions
Clinical disease
Virus variability
Epidemiology and disease burden
Immune correlates of protection
Candidate HIV vaccines: preclinical development
The challenge of eliciting broadly neutralizing antibodies against HIV-1
Passive immunoprophylaxis and immunotherapy
Clinical trials of HIV vaccines
Therapeutic vaccines
Summary and future directions in HIV vaccine development
Acknowledgments
Chapter 52: Lyme disease vaccines
Clinical description
Bacteriology
Pathogenesis
Diagnosis
Treatment and prevention with antimicrobials
Early infection (local or disseminated)
Neurologic abnormalities (early or late)
Arthritis (intermittent or chronic)
Cardiac abnormalities
Pregnant women
Epidemiology
Passive immunization
Active immunization
Future considerations
Summary
Chapter 53: Malaria vaccines
Background
Epidemiology and burden of disease
Vaccinology
Vaccines in late-stage development
Vaccines in early-stage development
Chapter 54: Noninfectious disease vaccines
Introduction
Tolerance, T-cell help, and how to induce antibodies against self
Targets for therapeutic B-cell vaccination
Conclusion―outlook
Chapter 55: Respiratory syncytial virus and parainfluenza virus vaccines
Background
Epidemiology
Mechanisms of immunity and correlates of protection
Passive immunization against RSV
Vaccine development
Conclusions
Chapter 56: Parasitic disease vaccines
Anthelmintic vaccines
Antiprotozoan vaccines
Chapter 57: Staphylococcus aureus vaccines
Ecology
The clinical spectrum
The problem of antimicrobial resistance in S. aureus: epidemic community-acquired methicillin-resistant disease
Microbiology and pathogenesis
Do we need a staphylococcal vaccine?
Vaccine development
Other potential vaccine targets
Epilog
Acknowledgments
Chapter 58: Streptococcus group A vaccines
Introduction
Background
Active immunization
Indirect effects
Future challenges
Chapter 59: Streptococcus group B vaccines
Background
Epidemiology
Active immunization
Immunogenicity
Safety
Public health considerations
Future vaccines
Chapter 60: Technologies for making new vaccines
Active vaccines
Passive vaccines
Conclusion
Chapter 61: Alternative vaccine delivery methods
Cutaneous vaccination
Jet injection
Respiratory vaccination
Conclusion
Disclosure
Acknowledgments
Chapter 62: The development of gene-based vectors for immunization
Nonviral vectors and DNA vaccines
Viral vectors
Vectors in development
Clinical applications of gene-based vector technology
Section 4: Vaccination of special groups
Chapter 63: Vaccination of immunocompromised hosts
Patients with cancer
Allogeneic hematopoietic stem cell transplantation recipients
Autologous hematopoietic stem cell transplantation recipients
Solid organ transplant recipients
Primary immunodeficiency diseases
Chronic inflammatory disorders
Household contacts of immunocompromised persons
Future directions
Chapter 64: Vaccination of human immunodeficiency virus쭯infected persons
Guidelines for use of vaccines in HIV-infected persons
Nonreplicating vaccines
Live bacterial vaccines
Live virus vaccines
Summary
Chapter 65: Vaccines for international travel
International travel
General information about immunizations for international travel
Vaccines for travel
Cost-effectiveness of travel immunizations
The future
Chapter 66: Vaccines for health care personnel
Vaccines recommended for health care personnel
Providing vaccines for health care personnel
Improving vaccine coverage of health care personnel
Guidelines for the use of selected vaccines
Conclusions
Section 5: Public health and regulatory issues
Chapter 67: Immunization in the United States
Immunization recommendations
The US immunization program
Roles of the US immunization program
Impact of immunization programs
Conclusion
Chapter 68: Immunization in Europe
Overview
Policy-making processes in European countries
Organizations working in immunization in the European region
World Health Organization (WHO) Regional Office for Europe
European Technical Advisory Group of Experts on Immunization (ETAGE)
UNICEF Regional Office for Central and Eastern European and Commonwealth of Independent States (UNICEF CEE/CIS)
European Union
Global Alliance for Vaccines and Immunization (GAVI)
Procurement
Vaccine-preventable diseases: surveillance in the European Region (as of 2011)
Vaccines used in the European Region and immunization coverage (as of 2011)
European Region strategy for strengthening national immunization systems
Health system reforms in the European Region
The next decade of immunization in the European Region
Chapter 69: Immunization in the Asia-Pacific region
Vaccines developed in and for the Asia-Pacific region
Clinical development and regulatory approval
Vaccine production
Vaccine policy and schedules
Vaccine delivery and coverage
Future trends and challenges
Acknowledgments
Chapter 70: Immunization in developing countries
Policies and strategies for vaccines included in NIPs
Management and logistics for immunization
Monitoring and evaluation of immunization programs
Progress, challenges, and opportunities
Conclusions
Sources of information on vaccines
Acknowledgments
Chapter 71: Community immunity
Historical background
Theoretical arguments
The real world
Discussion
Acknowledgment
Chapter 72: Economic analyses of vaccine policies
Important considerations in quantitative policy analysis
Examples of uses of quantitative policy analysis
Other economic considerations
Conclusion
Acknowledgments
Chapter 73: Regulation and testing of vaccines
Historical perspective
Federal laws and regulations
Stages of the regulatory review of biological products
Vaccine testing
Adverse event monitoring
Product labeling and advertising
Special considerations
Emerging post-licensure issues: detection of porcine circoviruses in rotavirus vaccines
Conclusion
Acknowledgments
Chapter 74: Regulation of vaccines in Europe
Marketing authorization
Scientific advice and authorization of clinical trials
Requirements for pediatric medicinal products
Medicinal products intended for markets outside the European Union
Risk management
Part I
Part II
Annexes
Safety specification
Pharmacovigilance plan
Postauthorization evaluation of benefits and risks
Marketing Authorization Holder
Member States
European Medicines Agency
Committee for Human Medicinal Products Rapporteur
Committee for Human Medicinal Products Pharmacovigilance Working Party
Committee for Human Medicinal Products Vaccine Working Party
Committee for Human Medicinal Products
European Commission
Communication of benefits and risks
Summary
Acknowledgement
Chapter 75: Regulation of vaccines in developing countries
Regulation of vaccines
WHO prequalification program for vaccines
Current status of assured-quality vaccines and functionality of NRAs by regulatory function
Initiatives to strengthen regulatory systems in developing countries for regulatory oversight of vaccines
Future directions
Chapter 76: Vaccine safety
Methods of monitoring immunization safety
Safety of mass immunization campaigns
Vaccine fears
Vaccine risk communication
Future considerations
Acknowledgments
Chapter 77: Legal issues
Vaccine liability before 1986
National Childhood Vaccine Injury Act
National Vaccine Injury Compensation Program
VICP cases since 1986
Modifying the VIT
Medical review of claims
Ongoing challenges
Vaccine liability since 1986
International compensation programs
The power to compel vaccination
Summary, conclusions, and future implications
Acknowledgments
Chapter 78: Ethics
Ethical issues unique to vaccination
Ethical considerations in the vaccine life cycle: an overview
Special topics in vaccine ethics
Conclusion: the future of vaccine ethics
Appendix: Web Sites That Contain Information About Immunization
Index