TY  - BOOK
AU  - Milligan,Gregg N.
AU  - Barrett,Alan D.T.
TI  - Vaccinology: An Essential Guide
SN  - 9781118636282
AV  - RA638 -- .V33 2015eb 
PY  - 2015///
CY  - Newark
PB  - John Wiley & Sons, Incorporated
KW  - Vaccines - therapeutic use
KW  - Electronic books
N1  - Cover -- Title page -- Copyright page -- Contents -- 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 -- Vaccines developed by trial and error -- Vaccines prepared by trial and error attenuation -- Vaccines for polysaccharide encapsulated bacteria -- Vaccines for hepatitis viruses -- Vaccines for human papillomaviruses -- Influenza -- Influenza vaccines -- Inactivated influenza vaccines -- Live attenuated influenza vaccine -- Rotavirus vaccines -- Further reading -- 2: The vaccine development pathway -- Introduction -- Regulation and approval of vaccines -- Basic research and development -- Manufacturing and process development -- Investigational New Drug Application: the "IND" -- Clinical trials -- The biologics license application -- Meetings with regulatory agencies -- Post-licensure activities -- Alternative pathways to licensure -- Further reading -- 3: Control and eradication of human and animal diseases by vaccination -- The control of diseases by vaccination -- Herd immunity -- Smallpox -- Rinderpest -- Poliomyelitis -- Measles -- Foot-and-mouth disease -- Other potentially eradicable diseases -- 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 -- Tetanus -- Diphtheria -- Anthrax; Diseases for which killed pathogen vaccines were developed -- Rabies -- Respiratory syncytial virus -- Epidemic louse-borne typhus -- Live attenuated pathogen vaccines -- Epidemic louse-borne typhus -- Yellow fever -- Childhood viral infections -- Subunit vaccines -- Hepatitis B -- Neisseria meningitidis -- Streptococcus pneumoniae -- Further reading -- 5: The host immune response, protective immunity, and correlates of protection -- Introduction -- Induction of innate immunity -- Toll-like receptors -- RIG-I-like receptors -- NOD-like receptors (NLRs) -- C-type lectin receptors -- 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 -- Exotoxin-producing bacteria -- Yellow fever virus -- Variola (Smallpox) -- Varicella zoster virus (chickenpox/zoster) -- Rotavirus -- 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 -- Antigen delivery vehicles -- Immunostimulatory 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 -- Multi-segment viruses -- 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 -- Vaccine delivery -- Toward personalized vaccinology -- Conclusions -- Further reading -- 8: Microbial-based and material-based vaccine delivery systems -- Virus vectors as vaccine platforms -- DNA viruses -- Poxviruses -- Adenovirus -- Adeno-associated viruses -- RNA viruses -- Alphavirus vectors -- Newcastle disease virus (NDV) -- Measles virus -- Vesicular stomatitis virus and rabies virus -- Flaviviruses -- Lentiviruses -- Other vaccine vectors -- Bacterial vectors as vaccine platforms -- Bacterial cell surface display systems -- Gram-negative display systems -- Gram-positive display systems -- Novel tuberculosis vaccines -- Novel delivery systems -- Bacterial ghost system -- Genetic vaccination -- Plant vectors -- MucoRice -- Biomaterials: a new generation of vaccine adjuvants and vaccine platforms -- Strategies for antigen encapsulation and presentation -- Strategies for antigen delivery -- Nanogels -- Strategies for activating innate immunity -- Conclusions and future directions for biomaterials -- Further reading -- 9: Licensed vaccines for humans -- Introduction -- Immunization strategies -- Immunization -- Passive immunization -- Active immunization -- Maternal immunization -- Cocooning (maternal and family/household vaccination) -- Ring immunization -- Booster immunizations -- Cell culture used to prepare vaccines -- Vaccine excipients -- Hypersensitivity -- Route of administration -- Dosing regimen -- Mucosal-based vaccines -- Specific vaccine types -- Live attenuated vaccines -- Inactivated vaccines -- Bacterial subunit vaccines; Viral subunit vaccines -- DNA vaccines -- Vaccines for special populations -- Other considerations -- 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 -- Live attenuated virus vaccines -- Inactivated or killed virus vaccines -- Bacteria -- Parasites -- Fungi -- Status of vaccines for aquaculture -- Future challenges -- Further reading -- 11: Development of vaccines for microbial diseases -- Introduction -- Principles of vaccine design -- Product development pathway -- Upstream processes -- Downstream processes -- 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) -- Animal models -- Nonclinical vaccine immunogenicity and efficacy -- Nonclinical vaccine safety and toxicity -- Good laboratory practices -- Further reading -- 12: The regulatory path to vaccine licensure -- Introduction -- Regulation of biologics -- The biological IND -- 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 -- The "Animal Rule" -- Accelerated approval and priority review -- Environmental risk assessment -- Scope -- New Drug Application and Common Technical Document -- Common Technical Document -- Electronic submissions -- Submission and review of the NDA -- Maintenance 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 -- Health Canada -- 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 -- United States of America -- European Union (EU) -- 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 -- Manufacturing steps -- Manufacturing definitions -- Examples of cell substrates -- Vaccine manufacturing: overview -- Examples of vaccine production -- Analytical aspects -- Good manufacturing practices -- Good manufacturing practices -- Good cell culture practices -- Good distribution and supply practices -- Future outlook -- New technologies -- Vaccine safety -- Mucosal vaccination -- Elimination of preservatives -- Influenza viral drift -- Further reading -- 15: Clinical evaluation of vaccines -- Introduction -- Phases of clinical trials -- Phase I -- Phase II -- Phase III -- Phase IV -- 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? -- Recommendations -- Mandates -- What are vaccination schedules? -- Are there any exceptions for certain people (special populations)? -- Children -- Adults -- Aging adult population -- Pregnant women -- Newborns; Altered immunocompetence
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