基于孕妇免疫策略的疫苗临床研究设计及应用  

Clinical research design and application of vaccines based on maternal immunization

作　　者：刘玥 贾斯月 马鑫模 文凤 朱凤才[2] 李靖欣 Liu Yue;Jia Siyue;Ma Xinmo;Wen Feng;Zhu Fengcai;Li Jingxin(School of Public Health,Southeast University,Nanjing 210009,China;Jiangsu Provincial Medical Innovation Center,National Health Commission Key Laboratory of Enteric Pathogenic Microbiology,Jiangsu Provincial Center for Disease Control and Prevention(Jiangsu Provincial Academy of Preventive Medicine),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(江苏省预防医学科学院)/国家卫生健康委员会肠道病原微生物重点实验室/江苏省医学创新中心,南京210009

出　　处：《中华流行病学杂志》2025年第2期345-351,共7页Chinese Journal of Epidemiology

基　　金：国家自然科学基金优秀青年基金(82222062);江苏省杰出青年基金(BK20220064)。

摘　　要：孕妇免疫策略是一种高效的公共卫生策略,其通过为孕妇接种疫苗来提高经胎盘转移的母体特异性抗体水平,从而在保护母体自身的同时也保护胎儿、新生儿和婴儿早期免受相应病原体的感染。目前,百日咳、流感等疫苗的孕妇免疫策略已经在全世界范围内广泛应用,通过孕妇免疫平台来预防婴儿感染呼吸道合胞病毒也取得了积极的成果。而我国基于孕妇免疫策略的疫苗临床研究鲜有报道。因此,本文对随机对照试验、队列研究、病例对照研究以及监测数据研究设计类型的孕妇免疫策略临床研究进行梳理,总结了各种设计类型的优势和劣势,并讨论了孕妇免疫策略的应用前景,以期为今后我国开展相关方面的研究提供参考。Maternal immunization is a highly effective public health strategy.The administration of vaccines to pregnant women increases the level of specific transplacental maternal antibodies,thereby protecting the pregnant fetuses,newborns,and early-life infants from the corresponding pathogens.Currently,maternal immunization strategies for pertussis,influenza,etc.have been widely used worldwide,and positive results have been achieved in preventing respiratory syncytial virus infection in infants.This article reviews different designs of maternal vaccination clinical studies,including randomized controlled trials,cohort studies,case-control studies,and surveillance data studies.It summarizes the strengths and weaknesses of different study approaches and discusses the application of maternal immunization strategies to provide a reference for developing maternal immunization research in China.

关 键 词：疫苗 孕妇免疫 临床研究 

分 类 号：R186[医药卫生—流行病学]