疫苗的非临床安全性研究

Nonclinical safety study of vaccines

通过查阅近年来与疫苗安全性评价研究相关的国内外文献、指导原则,结合已有的疫苗评价经验,对疫苗非临床安全性研究的必要性、主要关注点、评价项目和评价方法进行综述,为疫苗的安全性评价提供参考。安全性评价是疫苗非临床研究的重要组成部分,其主要关注点包括免疫原性、免疫毒性、系统毒性及局部刺激性等,应确定合适的实验动物种属、免疫剂量和频率等,进行包括重复给药毒性研究、急性毒性研究、过敏试验和生殖毒性试验等在内的全面评价。疫苗的非临床安全性研究可为临床研究提供重要的参考资料。应根据疫苗的具体特点和作用机制,应用适当的评价指标和检测方法,进行系统和深入的安全性研究。

In this article, we summarized the necessity, main concerns, evaluation items and methods of nonclinical safety study of vaccines, through looking up domestic and foreign literature and guidelines on the safety study of vaccines in recent years, and combining with existing vaccine evaluation experience. These will provide references for the safety evaluation of vaccines. The safety study is an important part of the nonclinical study of vaccines, with the primary focus on immunogenicity, immunotoxicity, systemic toxicity and local irritation. Appropriate species of test animals, immunization dosage and frequency should be determined. Comprehensive evaluations, including studies of repeated dose toxicity, acute toxicity, allergy and reproductive toxicity, should be carried out. The nonclinical safety study of vaccines can supply important references for its clinical study. The systematical and thorough safety study should be carried out using appropriate evaluation indexes and detection methods according to the specific features and mechanism of action of the vaccine.