案例信息
标题：首个国产HPV疫苗III期随机对照临床试验的设计与实践
【专业学位类别】 公共卫生
【专业领域/方向】 流行病学
【作者】 吴婷
【单位】 厦门大学公共卫生学院
【关键词】随机对照、临床试验、人乳头瘤病毒、疫苗、宫颈癌
【适用课程】流行病学、转化医学、生物制品学
【版权说明】真实性案例，仅用于教学目的
【案例摘要】
III期临床试验是疫苗上市前极其关键的环节，我国急需熟悉疫苗临床试验研究的人才。厦门大学牵头研发的首个国产HPV疫苗2019年12月在国内获批上市，2021年获WHO PQ认证，为全球宫颈癌防控提供了新的高质量的疫苗供给。本案例介绍我国首个HPV疫苗III期临床试验的设计与实践。该研究采用随机、双盲、对照设计，招募18~45岁健康女性，按年龄分层后随机至试验组或对照组。研究主要终点为HPV 16/18相关的高度生殖器癌前病变和持续性感染。结果显示，受试疫苗能有效预防HPV 16和/或18相关的高度生殖器病变和持续性感染。通过解读该研究的关键环节，使学生掌握随机双盲试验这一重要实验流行病学研究方法的基本概念，学习方案设计与实施，培养学生开展临床试验研究的能力。
Title: A Phase III Multicenter, Randomized Controlled Trial of Recombinant Human Papillomavirus 16/18 Bivalent Vaccine
Professional Degree Category: Master of Public Health
Specialized fields: Epidemiology
Authors: Ting Wu
Affiliation: School of Public Health, Xiamen University
Key words: Randomized controlled, Clinical trial, Human papillomavirus, Vaccine, Cervical cancer
Abstract
Phase III clinical trial is a key step before vaccine is marketed, it is urgent need of talents familiar with vaccine clinical trial in China. The first domestic HPV vaccine developed by Xiamen University was licensed in China in Dec 2019 and has been accepted by WHO for prequalification in 2021, which provide a new high-quality vaccine for cervical cancer prevention and control worldwide. This case mainly introduces the phase III clinical trial of the new bivalent HPV vaccine. The study is a multicenter, randomized, double-blind, controlled clinical trial in adult women. In total, eligible women aged 18~45 years were age-stratified and randomly assigned according to a permuted block randomization list to receive the test or control vaccine. Co-primary endpoints included high grade genital lesions and persistent infection (over 6 months）associated with HPV 16/18. The study suggested that the HPV 16/18 vaccine is highly efficacious against HPV 16/18-associated high-grade genital lesions and persistent infection in women. By interpreting the critical components of the study, we help students to grasp the basic concepts, and to learn the protocol design and implementation method of randomized double-blind trial that is an important experimental epidemiological research method, and to acquire ability to carry out clinical trial.
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