Vaccinology by Milligan, Gregg N. -- Read -- Imperial Library of Trantor

Index

Cover Table of Contents Title page Copyright page Contributors Preface 1: The History of Vaccine Development and the Diseases Vaccines Prevent

The 18th Century: Vaccines for Smallpox The 19th Century: New Understanding of Infectious Diseases and Immunity The 20th Century: The Control of Diseases Using Vaccines Vaccines Influenza Rotavirus Vaccines Further reading

2: The vaccine Development Pathway

Introduction Regulation and Approval of Vaccines Investigational New Drug Application: The “IND” The Biologics License Application Further reading

3: Control and Eradication of Human and Animal Diseases by Vaccination

The Control of Diseases by Vaccination Further reading

4: Pathogenesis of Infectious Diseases and Mechanisms of Immunity

Introduction Definitions: Colonization, Infection, Disease, Signs, Symptoms Transmission and Portal of Entry Routes of Spread in the Body Target Organs and Cells Mechanisms of Tissue Injury and Disease Pathogen Evasion of Host Defenses Vaccines for Infectious Diseases and Mechanisms of Vaccine-Induced Immunity Toxin-Mediated Diseases Diseases for Which Killed Pathogen Vaccines Were Developed Live Attenuated Pathogen Vaccines Subunit Vaccines Further reading

5: The Host Immune Response, Protective Immunity, and Correlates of Protection

Introduction Induction of Innate Immunity Bridging Innate and Adaptive Immunity Development of Adaptive Immune Responses T Lymphocyte Immunity B Lymphocyte Immunity T Cell-Dependent B-Cell Responses Persistent Production of Vaccine-Specific Antibody and B-cell Memory T Cell-Independent B-Cell Responses Mechanisms of Antibody-Mediated Protection Development of Immunity at Mucosal Sites Correlates of Protection Benefits of Identifying a Vaccine Correlate of Protection Mechanisms of Vaccine-Induced Protection Further Reading

6: Adjuvants: Making Vaccines Immunogenic

What Is an Adjuvant and Why Are They Added to Certain Vaccines? Characteristics of a Good Adjuvant Safety Types of Vaccine Adjuvants Combination Adjuvants Adjuvants for Veterinary Vaccines Future Challenges Further reading

7: Discovery and the Basic Science Phase of Vaccine Development

Basic Science and Translational Research Mechanisms of Disease and Comparative Pathogenesis Molecular Biology and Recombinant Vaccines Therapeutic Vaccines and Vaccines Against Noninfectious Agents Immunology of Protection and Adjuvants High-Throughput Methods and Systems Biology Bioinformatics and Reverse Vaccinology Additional Roles for Basic Science in Vaccine Development Conclusions Further reading

8: Microbial-Based and Material-Based Vaccine Delivery Systems

Virus Vectors as Vaccine Platforms DNA Viruses RNA Viruses Other Vaccine Vectors Bacterial Vectors as Vaccine Platforms Novel Tuberculosis Vaccines Novel Delivery Systems Plant Vectors Biomaterials: a New Generation of Vaccine Adjuvants and Vaccine Platforms Strategies for Antigen Encapsulation and Presentation Strategies for Antigen Delivery Strategies for Activating Innate Immunity Conclusions and Future Directions for Biomaterials Further reading

9: Licensed Vaccines for Humans

Introduction Immunization Strategies Specific Vaccine Types Further reading

10: Veterinary Vaccines

Vaccine Selection for Companion and Food-Producing Animals Status of Veterinary Vaccines for Infectious and Noninfectious Diseases in Companion and Food-producing Animals Viruses Bacteria Parasites Fungi Status of Vaccines for Aquaculture Future Challenges Further Reading

11: Development of Vaccines for Microbial Diseases

Introduction Principles of Vaccine Design Examples of Vaccine Development and Production Inactivated Virus Vaccine Development (Yellow Fever) Animal Models Good Laboratory Practices Further Reading

12: The regulatory Path to Vaccine Licensure

Introduction Regulation of Biologics The Biological IND The US FDA CBER IND Review Process Alternate Licensure Strategies Environmental Risk Assessment New Drug Application and Common Technical Document Worldwide Regulatory Authorities Further Reading

13: Veterinary Vaccines: Regulations and Impact on Emerging Infectious Diseases

Global Veterinary Vaccine Market Veterinary versus Human Vaccine Development Veterinary Vaccine Regulations: an Overview Veterinary Vaccine Regulations: USA, European Union, and Australia Animal Testing During Vaccine Development Impact of Veterinary Vaccines in Public Health Response of National Authorities to Animal Disease Threats Future Challenges Further Reading

14: Vaccine Manufacturing

Introduction Manufacturing Principles Analytical Aspects Good Manufacturing Practices Future Outlook Note Further reading

15: Clinical Evaluation of Vaccines

Introduction Phases of Clinical Trials Government Jurisdiction The Investigational New Drug Process Good Clinical Practice (GCP) The Sponsor The Investigator Institutional Review Boards and Independent Ethics Committees Conclusion Further reading

16: Vaccine Recommendations and Special Populations

What Happens After a Vaccine Is Licensed? What Are Vaccination Schedules? Are There Any Exceptions for Certain People (Special Populations)? Conclusion Further reading

17: Vaccine Safety

Introduction Vaccine Safety in Vaccine Development Vaccine Safety Post-Approval Causality Assessment Examples of Vaccine Fears Communication Perspective in Vaccine Safety Further reading

18: Understanding and Measuring the Dynamics of Infectious Disease Transmission

Concepts of Infectious Disease Transmission Measures of Disease Transmission Introduction to Infectious Disease Modeling Further Reading

19: Vaccines from a Global Perspective

The Global Perspective Diseases Infrastructure Regulatory Future Challenges Further Reading

20: Political, Ethical, Social, and Psychological Aspects of Vaccinology

Introduction Politics in Vaccinology Cognitive Biases, Distortions, and Preferred Cognitive Styles in Vaccine Decision Making Ethical Issues in Vaccination Further Reading

Index End User License Agreement