Vaccinology An Essential Guide 1st edition by Gregg Milligan, Alan Barrett – Ebook PDF Instant Download/Delivery: 0470656166 , 978-0470656167
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ISBN 10: 0470656166
ISBN 13: 978-0470656167
Author: Gregg Milligan, Alan Barrett
Vaccinology: An Essential Guide outlines in a clear, practical format the entire vaccine development process, from conceptualization and basic immunological principles through to clinical testing and licensing of vaccines. With an outstanding introduction to the history and practice of vaccinology, it also guides the reader through the basic science relating to host immune responses to pathogens.
Covering the safety, regulatory, ethical, and economic and geographical issues that drive vaccine development and trials, it also presents vaccine delivery strategies, novel vaccine platforms (including experimental vaccines and pathogens), antigen development and selection, vaccine modelling, and the development of vaccines against emerging pathogens and agents of bioterror. There are also sections devoted to veterinary vaccines and associated regulatory processes.
Vaccinology: An Essential Guide is a perfect tool for designed for undergraduate and graduate microbiologists and immunologists, as well as residents, fellows and trainees of infectious disease and vaccinology. It is also suitable for all those involved in designing and conducting clinical vaccine trials, and is the ideal companion to the larger reference book Vaccinology: Principles and Practice.
Vaccinology An Essential Guide 1st Table of contents:
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
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