桥接试验设计在预防性疫苗临床研究中的应用  

Application of bridging study design in preventive vaccine clinical trials

作　　者：朱雅文 夏芯 李镯沛 吴燕飞 朱凤才[3] 李靖欣 Zhu Yawen;Xia Xin;Li Zhuopei;Wu Yanfei;Zhu Fengcai;Li Jingxin(School of Public Health,Nanjing Medical University,Nanjing 211166,China;School of Public Health,Southeast University,Nanjing 210009,China;National Health Commission(NHC)Key Laboratory of Enteric Pathogenic Microbiology,Jiangsu Provincial Center for Disease Control and Prevention,Nanjing 210009,China)

机构地区：[1]南京医科大学公共卫生学院,南京211166 [2]东南大学公共卫生学院,南京210009 [3]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,南京210009

出　　处：《中华预防医学杂志》2023年第12期2201-2211,共11页Chinese Journal of Preventive Medicine

摘　　要：在疫苗临床研究中,桥接试验是指在疫苗原有的安全性和有效性在临床试验中已得到证实的基础上,再通过一系列的小规模附加试验,证明疫苗从一种组分、人群、接种程序等改变为其他类型后的安全性、免疫原性及有效性特征与改变之前的特征具有相似性或一致性,从而可以将原有的临床试验数据外推的研究。与传统的疫苗临床试验相比,桥接试验可以推进疫苗获得批准上市,可加快扩大疫苗的应用范围,促进疫苗的跨地域和跨人群应用。近年来,桥接试验设计在疫苗临床研究中的应用愈加常见。为了更好地指导和推广桥接试验设计在疫苗临床研究领域的应用,本研究拟对桥接试验设计在疫苗临床试验中的设计的特点及应用实例进行梳理,对桥接试验设计思路、要点和统计学评价方法进行系统阐述。Bridging study in vaccine clinical trials means a series of small-scale additional tests on the basis that the original safety and effectiveness of a vaccine have been confirmed in clinical trials,to prove that the characteristics of safety,immunogenicity and effectiveness of a vaccine are similar or consistent after component,population and immunization procedure change to other types which can extrapolate data from existing clinical trials.Compared with traditional vaccine clinical trials,bridging trials can promote the approval of vaccines to the market,accelerate the expansion of vaccine application,and promote the use of vaccines across regions and populations.In recent years,the application of bridge study design in vaccine clinical research has become more and more common.In order to better guide and promote the application of bridging trial design in the field of vaccine clinical research,we reviewed the design characteristics and application examples of bridging study design in vaccine clinical trials,and systematically elaborated the design ideas,key points and statistical evaluation methods of bridging study.

关 键 词：桥接 疫苗 临床试验 

分 类 号：R392-33[医药卫生—免疫学]