《生命科学》 2013, 25(9): 858-864
摘 要：摘 要：核酸疫苗是20 世纪90 年代兴起的一种新型疫苗，已在免疫学及预防医学等方面显示出巨大潜能，迄今已有10 余种被FDA 批准进入非临床和临床试验。然而，目前仍存在许多尚未解决的问题，如生产工艺、质量标准、制剂和效应，特别是安全性方面的问题，它直接关系到核酸疫苗的应用。因此，解决安全问题是目前核酸疫苗研究的热点和焦点。核酸疫苗的安全隐患主要包括基因整合、免疫学疾病、种属、个体差异性及生产带来的一些安全隐患。为此，对其进行优化设计及生产主要应从表达载体、免疫佐剂、免疫途径及免疫程序等方面进行优化。主要就核酸疫苗的安全性方面问题及有关优化策略作一综述，希望对核酸疫苗的基础研究与临床应用具有一定的指导意义。
关键词：核酸疫苗；安全性；优化
Abstract: Abstract: Nucleic acid vaccine is a brand-new vaccine sprung up in 1990s， and has shown its tremendous potentials in immunology and preventive medicals. Up to date， more than 10 DNA vaccines have been approved by FDA to conduct clinical and non-clinical experiments. However， there are still some unsolved problems， such as manufacturing techniques， quality standards， preparation and effects. Among the problems， safety is of major importance as it has a direct bearing on the application of DNA vaccine. Therefore， to address the security concern is the hot-spot and focus of current research on DNA vaccine. For the time being， security risks mainly include gene integration， immunologic diseases， difference of species and individuals， risks emerging in manufacturing process. To this end， we are supposed to optimize the designation and manufacturing of it， mainly from aspects such as expression vector， immunoadjuvant， immunization route， and immunization program. This paper aims to give a review on safety of DNA vaccine as well as optimum strategies， and thus be of significance to fundamental and clinical researches.
Key words: nucleic acid vaccine; safety; optimization
