Ⅱ/Ⅲ期无缝设计在疫苗临床试验中的应用  

Application of seamless phaseⅡ/Ⅲdesign in vaccine clinical trials

作　　者：刘倩 金来润 金鹏飞 朱凤才[2] 李靖欣 Liu Qian;Jin Lairun;Jin Pengfei;Zhu Fengcai;Li Jingxin(School of Public Health,Southeast University,Nanjing 210009,China;Department of Vaccine Clinical Evaluation,Jiangsu Provincial Center for Disease Control and Prevention,Nanjing 210009,China;National Health Commission Key Laboratory of Enteric Pathogenic Microbiology,Jiangsu Provincial Center for Disease Control and Prevention,Nanjing 210009,China)

机构地区：[1]东南大学公共卫生学院,南京210009 [2]江苏省疾病预防控制中心疫苗临床评价所,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：《中华流行病学杂志》2024年第4期602-607,共6页Chinese Journal of Epidemiology

基　　金：江苏省基础研究计划自然科学基金(BK20220064);国家自然科学基金优秀青年科学基金(82222062);国家自然科学基金(82173584)。

摘　　要：Ⅱ/Ⅲ期无缝设计是将独立的Ⅱ期和Ⅲ期临床试验整合为一个连续的、分阶段的适应性临床试验设计。相较于传统的独立Ⅱ期和Ⅲ期临床试验,无缝设计在加速药物或疫苗上市、提高临床试验效率方面具有显著的优势。目前该设计在抗肿瘤药物研究领域的应用上日益成熟,也逐渐扩展到疫苗的临床试验中,包括九价人乳头瘤病毒疫苗、Sabin株脊髓灰质炎灭活疫苗等。本文旨在阐述Ⅱ/Ⅲ期无缝设计的概念,并以九价人乳头瘤病毒疫苗的Ⅱ/Ⅲ期无缝设计的临床试验为例,阐述实施Ⅱ/Ⅲ期无缝设计时需注意的细节和潜在的挑战,以期为我国在优化疫苗临床试验方面提供参考。The seamless phaseⅡ/Ⅲdesign integrates independent phaseⅡand phaseⅢclinical trials into a continuous,phased adaptive clinical trial design.Compared with traditional independent phaseⅡand phaseⅢclinical trials,the seamless design offers significant advantages in accelerating drug or vaccine development and improving clinical trial efficiency.Currently,the application of this design in anti-tumor drug research is becoming increasingly mature,and it is gradually expanding to clinical trials of vaccines,including the 9-valent human papillomavirus vaccine,sabin strain inactivated polio vaccine,and others.This paper aims to clarify the seamless phaseⅡ/Ⅲdesign concept and offer valuable insights into its implementation.It accomplishes this by presenting a clinical trial example featuring a phaseⅡ/Ⅲseamless design for a 9-valent human papillomavirus vaccine.The article delves into the specific considerations and potential challenges related to implementing the seamless design,aiming to provide valuable insights for optimizing vaccine clinical trials within our country.

关 键 词：疫苗 临床试验 Ⅱ/Ⅲ期无缝设计 

分 类 号：R392-33[医药卫生—免疫学]