动物法则在疫苗临床评价中的应用  

The application of Animal Rule in the clinical evaluation of vaccines

作　　者：王家琪 金鹏飞 胡文婧 周利 朱凤才[1,4] 李靖欣 WANG Jiaqi;JIN Pengfei;HU Wenjing;ZHOU Li;ZHU Fengcai;LI Jingxin(School of Public Health,Southeast University,Nanjing,Jiangsu 210009,China;不详)

机构地区：[1]东南大学公共卫生学院,江苏南京210009 [2]江苏省疾病预防控制中心疫苗临床评价所 [3]南京医科大学公共卫生学院 [4]江苏省疾病预防控制中心,国家卫生健康委员会肠道病原微生物重点实验室

出　　处：《中国预防医学杂志》2025年第2期235-242,共8页Chinese Preventive Medicine

基　　金：国家自然科学基金资助项目(82222062);江苏省科技计划项目(BK20220064);江苏省重点研发计划(社会发展)专项资金项目(BE2021738)。

摘　　要：动物法则(Animal Rule)指无法在人群中开展疫苗临床试验的情况下,使用动物模型来评估疫苗的有效性,特别是针对严重威胁公众健康的疾病或生物安全的传染病,允许在动物模型中进行一系列严格设计的科学实验以替代人体临床试验。本研究旨在介绍动物法则在疫苗临床评价中的应用条件和实施原则,并以全球首个以动物法则数据获批适应证的炭疽疫苗为实例,详细阐述应用动物法则评价疫苗的设计方案要点,根据动物研究数据推断疫苗在人体中有效性的评价方法。研究讨论了动物法则应用于尼帕病毒疫苗、丝状病毒疫苗以及鼠疫疫苗的可能性,以及动物法则的优缺点,以期推进动物法则在我国疫苗的有效性评价中的应用。The"Animal Rule"refers to the use of animal models to evaluate the safety and efficacy of vaccines when human clinical trials cannot be conducted,especially for diseases that pose a significant threat to public health or involve biosecurity concerns.This approach allows for a series of rigorously designed scientific experiments in animal models as a substitute for human clinical trials.The aim of this article is to introduce the conditions and principles for the use of the Animal Rule in vaccine clinical evaluation,using the world's first anthrax vaccine approved based on Animal Rule data as a case study to detail the key design elements for evaluating vaccines under this framework.Additionally,methods for inferring vaccine efficacy in humans based on animal study data are discussed.The research also explores the potential application of the Animal Rule for vaccines against Nipah virus,filovirus,and plague,while evaluating the advantages and disadvantages of this approach,aiming to promote the use of the Animal Rule in the efficacy evaluation of vaccines in China.

关 键 词：动物法则 疫苗 临床评价 

分 类 号：R181[医药卫生—流行病学]