Overview of marker vaccine and differential diagnostic test technology
Overview of marker vaccine and differential diagnostic test technology
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DOI：
10.1016/j.biologicals.2005.08.006
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发表时间：
2005-12-01
期刊：
影响因子：
1.7
通讯作者：
Henderson, LM
中科院分区：
文献类型：
--
作者：
Henderson, LM
分子生物学、免疫学、微生物学、遗传学和微生物发病机制方面的最新进展导致了基于亚单位疫苗、基因缺失疫苗、活载体疫苗和DNA介导疫苗等设计的各种新方法的发展，以开发更安全、更有效的疫苗。技术工具可以是基本的，比如识别带有缺失的自然产生的菌株，以支持区分受感染动物(DIVA)的需要，或者基于更高的技术发展，如改进的蛋白质表达和纯化方法，转基因植物和植物病毒抗原的生产，以及针对特定免疫反应的新型佐剂。当这些新方法应用于标记疫苗和配套诊断检测试剂盒的开发时，具有开发用于根除和控制程序的改进工具的巨大潜力。标记疫苗和配套诊断检测试剂盒必须满足对纯度、效力、安全性和有效性的既定许可要求。功效声明是基于对宿主动物试验中证明的保护水平的评估，范围从“用(特定制剂)预防感染”到“用作减少(特定制剂)引起的疾病的辅助”。主张和建议的差异是不同疫苗在保护方面的不同所致。为了设计有效的根除计划，必须很好地定义疫苗效力特征，如减少感染易感性和感染传播；同样，必须确定诊断测试性能特征(效力)。除了支持效力声明的数据外，必须对疫苗生产和使用的安全性进行评估。在设计标记疫苗和诊断测试时，重要的是要考虑应用适当的技术来提高这些产品的安全性。使用重组技术生产疫苗和/或诊断测试抗原可以减少生产和使用期间的生物安全问题，包括人类在生产和使用期间暴露于人畜共患病病原体，以及由于失去生物遏制而可能传播外国动物病原体。此外，疫苗可能会引起不良反应。重要的是要确定不良事件的发生频率，并通过适当的设计减少诱发不良反应的可能性。由爱思唯尔有限公司代表国际生物制品协会出版。
Recent advances in molecular biology, immunology, microbiology, genetics and microbial pathogenesis have lead to the development of a wide variety of new approaches for developing safer and more effective vaccines based on designs such as subunit vaccines, gene deleted vaccines, live vectored vaccines, and DNA mediated vaccines. Technology tools can be as basic as identifying naturally occurring strains with deletions that support differentiating infected from vaccinated animal (DIVA) needs or be based on higher technology developments such as improved protein expression and purification methods, transgenic plant- and plant virus-based antigen production, and novel adjuvants that target specific immune responses. These new approaches, when applied to the development of marker vaccines and companion diagnostic test kits hold tremendous potential for developing improved tools for eradication and control programs.Marker vaccines and companion diagnostic test kits must meet the established licensing requirements for purity, potency, safety and efficacy. Efficacy claims are based on evaluation of the level of protection demonstrated in host animal trials and may range from "prevents infection with (a specific agent)", to "for use as an aid in the reduction of disease due to (a specific agent)." The differences in claims and recommendations are a function of the variation in protection elicited by various vaccines. For designing effective eradication programs, vaccine efficacy characteristics such as for reducing susceptibility to infections and spread of infections must be well defined; similarly, diagnostic test performance characteristics (efficacy) must be determined.In addition to data to support efficacy claims, it is imperative that safety of production and use of vaccines be evaluated. During the design of marker vaccines and diagnostic tests, it is important to consider the application of appropriate technologies to improve the safety of these products. Use of recombinant technologies for production of vaccines and/or diagnostic test antigens can reduce the biosafety concerns during production and during use, including human exposure to zoonotic pathogens during production and use, and potential spread of foreign animal disease agents due to loss of biocontainment. In addition, vaccines may induce adverse reactions. It is important to determine the frequency of adverse events and to reduce the likelihood of induction of adverse reactions through proper design. Published by Elsevier Ltd on behalf of The International Association for Biologicals.