Chapter
Vaccines for polysaccharide encapsulated bacteria
Vaccines for hepatitis viruses
Vaccines for human papillomaviruses
Inactivated influenza vaccines
Live attenuated influenza vaccine
2: The vaccine development pathway
Regulation and approval of vaccines
Basic research and development
Manufacturing and process development
Investigational New Drug Application: the “IND”
The biologics license application
Meetings with regulatory agencies
Post-licensure activities
Alternative pathways to licensure
3: Control and eradication of human and animal diseases by vaccination
The control of diseases by vaccination
Other potentially eradicable diseases
4: Pathogenesis of infectious diseases and mechanisms of immunity
Definitions: colonization, infection, disease, signs, symptoms
Transmission and portal of entry
Routes of spread in the body
Mechanisms of tissue injury and disease
Pathogen evasion of host defenses
Vaccines for infectious diseases and mechanisms of vaccine-induced immunity
Diseases for which killed pathogen vaccines were developed
Respiratory syncytial virus
Epidemic louse-borne typhus
Live attenuated pathogen vaccines
Epidemic louse-borne typhus
Childhood viral infections
5: The host immune response, protective immunity, and correlates of protection
Induction of innate immunity
NOD-like receptors (NLRs)
Bridging innate and adaptive immunity
Development of adaptive immune responses
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
Benefits of identifying a vaccine correlate of protection
Mechanisms of vaccine-induced protection
Exotoxin-producing bacteria
Varicella zoster virus (chickenpox/zoster)
6: Adjuvants: making vaccines immunogenic
What is an adjuvant and why are they added to certain vaccines?
Characteristics of a good adjuvant
Types of vaccine adjuvants
Antigen delivery vehicles
Immunostimulatory adjuvants
Adjuvants for veterinary vaccines
7: Discovery and the basic science phase of vaccine development
Basic science and translational research
Mechanisms of disease and comparative pathogenesis
Overlapping areas of research
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
Iterative cycle of vaccine development
Toward personalized vaccinology
8: Microbial-based and material-based vaccine delivery systems
Virus vectors as vaccine platforms
Newcastle disease virus (NDV)
Vesicular stomatitis virus and rabies virus
Bacterial vectors as vaccine platforms
Bacterial cell surface display systems
Gram-negative display systems
Gram-positive display systems
Novel tuberculosis vaccines
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
9: Licensed vaccines for humans
Cocooning (maternal and family/household vaccination)
Cell culture used to prepare vaccines
Bacterial subunit vaccines
Vaccines for special populations
Vaccine selection for companion and food-producing animals
Status of veterinary vaccines for infectious and noninfectious diseases in companion and food-producing animals
Live attenuated virus vaccines
Inactivated or killed virus vaccines
Status of vaccines for aquaculture
11: Development of vaccines for microbial diseases
Principles of vaccine design
Product development pathway
Examples of vaccine development and production
Recombinant protein (hepatitis B)
Bacterial polysaccharide (Streptococcus pneumoniae)
Inactivated virus subunits (influenza)
Inactivated virus (polio)
Live attenuated (measles)
Inactivated virus vaccine development (yellow fever)
Nonclinical vaccine immunogenicity and efficacy
Nonclinical vaccine safety and toxicity
Good laboratory practices
12: The regulatory path to vaccine licensure
Content and format of the IND
The US FDA CBER IND review process
CBER organization structure
The CBER review process for INDs
The IND and 30-day review clock
Alternate licensure strategies
Accelerated approval and priority review
Environmental risk assessment
New Drug Application and Common Technical Document
Common Technical Document
Submission and review of the NDA
Worldwide regulatory authorities
European Medicines Agency (EMA)
Japan’s Ministry of Health, Labor and Welfare
China Food and Drug Administration
Australia’s Therapeutic Goods Administration
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
14: Vaccine manufacturing
Manufacturing definitions
Examples of cell substrates
Vaccine manufacturing: overview
Examples of vaccine production
Good manufacturing practices
Good manufacturing practices
Good cell culture practices
Good distribution and supply practices
Elimination of preservatives
15: Clinical evaluation of vaccines
Phases of clinical trials
The investigational new drug process
Good clinical practice (GCP)
Institutional review boards and independent ethics committees
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)?
Behavioral and occupational risks
Vaccine safety in vaccine development
Initial exploratory discovery and nonclinical phase
Clinical studies with human subjects
Vaccine safety post-approval
Post-licensure safety and efficacy monitoring of vaccines
Examples of vaccine fears
Vaccines and mad cow disease
Measles, mumps, rubella vaccine causes autism
Oral polio vaccine trials in Belgian Congo and the origin of HIV
Communication perspective in vaccine safety
Risk perception and irrational behavior
Public health and public communication
18: Understanding and measuring the dynamics of infectious disease transmission
Concepts of infectious disease transmission
Characteristics of infectious agents, hosts, and environments
Measures of disease transmission
Transmission probability (β) and secondary attack rate
Basic reproductive number (R0)
Introduction to infectious disease modeling
Suspectible, Infected, and Recovered (SIR) model
19: Vaccines from a global perspective
Priority diseases for vaccine development
Eradication of infectious diseases
Economics of vaccine development
Major infectious diseases in the world
Private–public partnerships
National regulatory authorities
Regulation of veterinary vaccines
Genetically manipulated organisms
20: Political, ethical, social, and psychological aspects of vaccinology
Philosophical basis for politics in vaccinology
Cognitive biases, distortions, and preferred cognitive styles in vaccine decision making
Rationale for understanding the psychology of vaccine decision making
Models in health care decision making
The influence of groups and peers
Preferred cognitive styles
Ethical issues in vaccination
Parental refusal of childhood immunizations
Imminent risk of serious harm
Exemptions from required school-entry immunizations
The debate over personal belief exemptions
An intersection of knowledge and values
Vaccinology
：An Essential Guide
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