核酸疫苗的药动学与安全性研究进展  

Advances of pharmacokinetics and safety of nucleic acid vaccines

作　　者：付洁[1] 宋海峰[1] 

机构地区：[1]军事医学科学院放射与辐射医学研究所 药物代谢与药物动力学实验室,北京100850

出　　处：《中国新药杂志》2006年第5期337-340,共4页Chinese Journal of New Drugs

摘　　要：核酸疫苗是将编码某种抗原蛋白的外源基因(DNA或RNA)直接导入机体细胞内,通过宿主细胞的转录系统合成抗原蛋白,诱导宿主对该抗原蛋白的免疫应答,从而达到预防和治疗疾病的目的。作为一种新型疫苗,核酸疫苗迄今已有10余种被FDA批准进入非临床和临床试验,但其应用于人体的有效性、安全性、可接受性仍是值得关注的问题。基于对乙肝病毒DNA疫苗药动学的研究基础,结合近几年国内外相关研究,笔者对核酸疫苗的药动学与安全性进行综述。Establishing the effective use of ＇ naked＇ nucleic acids as vaccines in 90 s would undoubtedly be one of the most important advances in the history of vaccinology, which was regarded as ＂the third vaccine revolution＂. Although more than ten naked vaccines have been approved by FDA to use in experimental animals and clinical trials, efficacy, safety and acceptability are still three hurdles for this new biotech drug to be applied in humans. Here we illustrate progresses that have been made in the nucleic acid vaccines in passing years as well as the pharmacokinetics studies of HBV DNA vaccine we investigated. A focus on the pharmacokinetics and safety of the nucleic acid vaccines is made.

关 键 词：核酸疫苗 药动学 生物分布 安全性 

分 类 号：R967[医药卫生—药理学] R392.11[医药卫生—药学]