预防用疫苗临床试验安全性研究设计和实施的考虑

预防用疫苗(疫苗)的安全性是临床试验重点关注和评价的内容之一。本文结合近年来疫苗注册试验的审评实践,就安全性研究的常见问题提出系列思考和建议,包括安全性研究假设,入排标准及暂停/终止标准的考虑,安全性观察的常规要求和临床指标、疫苗排毒及佐剂安全性等特殊研究内容,并进一步明确了序贯入组的安全性观察要求,强调了因果相关性的科学判定和安全性监测工作质量等方面内容,供疫苗研发参考和借鉴,同时探讨适宜的解决方法,以促进我国疫苗研发和风险控制。

The consideration about study design and implementation of vaccine clinic trials

The safety of prophylactic vaccine is one of the key points both in clinical trials and evaluation.Based on the review practice of vaccine registration clinical trials in recent years,we puts forward a series of thoughts and suggestions on the common problems of safety study on vaccine,including the hypothesis of safety study,the consideration of inclusion/exclusion criteria and suspension/termination criteria for study;the routine requirements of safety study and some special issue such as medical laboratory test index,vaccine virus shedding and safety of adjuvant,and further clarifies the requirements of safety observation on sequential enrollment;also emphasized the scientific judgment of causality and the quality of safety monitoring.It can be used for reference by vaccine researchers and to explore appropriate solutions to promote vaccine research&development and risk control in China.