案例信息

标题：全球首个戊肝疫苗III期临床试验及延续性监测的研究设计与实践

【专业学位类别】 公共卫生

【专业领域/方向】 流行病学

【作者】 张军 教授

【单位】 厦门大学公共卫生学院

【关键词】随机对照、临床试验、戊型肝炎病毒、戊型肝炎、疫苗

【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】疫苗Ⅲ期临床试验的意义在于验证疫苗在大规模人群中的有效性及安全性，为其获得批准并被广泛应用提供可靠的科学支持。厦门大学牵头研发的全球首个戊型肝炎疫苗于2011年和2020年先后在中国和巴基斯坦获批上市，2022年经无国界医生组织应用于南苏丹的戊肝疫情防控，是目前人类唯一的可用于预防戊肝疾病的生物制品。本案例介绍全球首个戊肝疫苗III期临床试验及延续性监测的研究设计与实践。该研究采用随机、双盲、安慰剂对照设计，招募16-65岁健康人群，样本量约11万，按性别和年龄分层后1：1随机至试验组或对照组，研究主要目的为评价戊肝疫苗的有效性及安全性。Ⅲ期临床试验结果显示，受试疫苗全程接种后1年内的有效性高达100.0%。随后开展的延续性监测研究结果显示，4.5年内疫苗有效性仍有93.3%。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 Clinical Trial and Extension Follow-up Study of the World’s First Hepatitis E Vaccine

Professional Degree Category: Master of Public Health

Specialized fields: Epidemiology

Authors: Jun Zhang

Affiliation: School of Public Health, Xiamen University

Key words: Randomized controlled, Clinical trial, Hepatitis E virus, Hepatitis E, Vaccine

Abstract

The significance of Phase III clinical trials for vaccines lies in verifying their efficacy and safety in large populations, providing reliable scientific support for their approval and widespread application. The world's first Hepatitis E vaccine, developed by Xiamen University, was approved in China and Pakistan in 2011 and 2020 respectively. In 2022, it was utilized by Médecins Sans Frontières for Hepatitis E outbreak control in South Sudan. Currently, this vaccine is the sole available bioproduct for preventing Hepatitis E. This case introduces the trial design and implementation of the Phase III clinical trial and extension study for the world’s first Hepatitis E vaccine. The study was randomized, double-blind, placebo-controlled, and conducted in a healthy population aged 16-65, with a sample size of around 110,000. All participants in the study were randomly assigned to either the vaccine or placebo group in a 1:1 ratio, stratified by sex and age. The primary objective was to evaluate the vaccine efficacy and safety. The results of the phase III trial demonstrated an efficacy of 100.0% within one year after three doses. Subsequent long-term extended follow-up study showed an efficacy of 93.3% over 4.5 years. By dissecting the critical elements of this study, students grasp the fundamental concepts of randomized double-blind trials as a vital epidemiological study method, learn about study design and implementation, and cultivate their ability to conceive and conduct clinical studies.