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本帖最后由 haofei_wu 于 2013-6-7 20:34 编辑
“Vaccinology” is a term that encompasses the
whole process of producing vaccines – from basic
research and preclinical demonstration of efficacy,
to approval and clinical trial in humans. While
there are many excellent books that detail the various
steps, such as antigen discovery or delivery
systems, there are fewer that also cover so called
“downstream development,” such as the design
of clinical trials, or their regulation in the United
States and the European Union. In this book we
have aimed to fill this gap by providing the reader
with a comprehensive and authoritative reference
that describes the design and construction of vaccines
from first principles to implementation. We
hope it will appeal both to scientists engaged in vaccine
research and development, and to clinicians,
or indeed anyone, with an interest in the opportunities
and challenges facing the development of
new vaccines.
To tackle this vast subject we have organized the
chapters into sections. We start with an examination
of the concept and scope of modern vaccines.
We follow this with the basic tenets of the immune
system that govern our thinking about vaccines,
with chapters on innate immunity, antigen processing
and presentation, mucosal immunity,
immunological memory in T and B cells, and the
utility of mouse and nonhuman primate models for
testing vaccine efficacy. In the following section we
explore antigen discovery in the postgenomic era,
during which there has been remarkable progress
in proteomic mining for potential vaccine antigens,
and powerful predictive algorithms and highthroughput
assay and display technologies. Together
these offer unprecedented opportunities for
the rapid development of new vaccines. This is then
followed by a selection of chapters on antigen engineering
and delivery: attenuated microbe vaccines,
virus-like particles, recombinant viruses (orthopox,
avipox, lentivirus, and adenovirus) and bacteria,
DNA vaccines, and artificial cells. In parallel we
explore methods for antigen delivery, with chapters
on transcutaneous vaccination, needle-free jet
delivery, and oral vaccines. The need to potentiate
otherwise inert proteins is the subject of the next
section, with chapters on designing adjuvants,
particulate delivery systems such as PLGs and
microspheres, co-administration of co-stimulatory
moieties, and the role of TLR signaling in adjuvanticity.
We then transition from basic research to
vaccine implementation. The first of these sections
discusses regulatory considerations, with chapters
on working with the US Food and Drug Administration
(FDA) and the European Medicines Agency
(EMA), developmental pipelines, the design of
clinical trials, immune monitoring and biomarkers,
and vaccine safety. This is followed by chapters on
mass immunization strategies, and mathematical
models and epidemiological monitoring.
This book would not be possible without the
impressive array of experts who have contributed
chapters. We wish to thank every one of you
for making this possible and bearing with us on
this ambitious project. Finally we wish to thank
the production team at John Wiley, especially
Julie Elliott, Maria Khan, and Michael Bevan. This
has been a team effort, but ultimately any omissions
or errors are the responsibility of the editors.
We welcome comments and feedback for future
editions of this book.
疫苗学原理与实践 疫苗学是一个包括从基础研究到效果的临床验证，直至人体临床试验和审批的疫苗生产的整个过程的专业名称。在美国和欧盟，现在有很多优秀的书籍，详细介绍其各个环节，如抗原的发现或者抗原传递系统，另外有一些书籍包括所谓的下游过程，例如临床试验的设计，或者与其相关的管理。在这本书中，我们的目的是，通过给读者提供关于描述疫苗设计和构建的从第一原则到实际操作的广泛而权威的参考以填补这项空白。我们希望它将吸引从事疫苗研究和改进的科学家以及临床学家，或者对新疫苗的发展所面对的机会和挑战感兴趣的任何人。 为了应对这项庞大的任务，我们将这些章节分为几个部分。我们从探讨现代疫苗的概念和所包含的内容开始。紧接着的是关于先天免疫、抗原加工和呈递、粘膜免疫、T细胞和B细胞免疫记忆的免疫系统基本内容的章节，它将引导我们对疫苗的思考。接下来的部分将探讨在后基因组时代的抗原的发现，在此期间，蛋白组学取得了长足的进步，人们开发出了高效的疫苗抗原，强大的预测方法和高通量的检测和展示技术。以上的这些技术，为新疫苗的快速开发提供了史无前例的机会。紧接着的是有关抗原工程和传递的章节，这要关于减毒的微生物疫苗，病毒样颗粒，重组病毒（痘苗，禽痘，慢病毒和腺病毒），细菌，DNA疫苗和人工细胞。与此同时，我们在有关皮下免疫、无针喷射传输和口服疫苗的章节中将探讨抗原传递的方法。增强非活性蛋白的免疫力是下一部分所要讲述的内容，所包含的章节主要关于设计佐剂，颗粒传递系统，如PLGs和微球，共刺激成分的使用，TLR信号在佐剂活性中的作用。接着，我们从基础研究转移到疫苗的实际运用。第一部分将讲述疫苗管理的相关内容，这些章节包含美国食品药品管理局和欧洲医药局的职能，开发流程，临床试验的设计，免疫检测和生物标记，疫苗安全。紧接着将介绍大规模免疫的方法，数学模型和流行病的监控。 本书各个章节由不同的专家编写。我们衷心感谢各位参与编写的专家，因为你们，使得这本书籍的诞生成为可能。最后，我们衷心感谢在John Wiley的排版工作组，尤其是Julie Elliott, Maria Khan, and Michael Bevan。这是一项团体努力的结果，最终任何的缺失和错误，都是编辑的责任。我们欢迎读者对本书提供宝贵的意见和建议，以便使未来的版本得到改进。 Vaccinology Principles and Practice序言
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发表于 2013-6-7 20:30:50
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