Abstract
刘玥,贾斯月,马鑫模,文凤,朱凤才,李靖欣.基于孕妇免疫策略的疫苗临床研究设计及应用[J].Chinese journal of Epidemiology,2025,46(2):345-351
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
Received:July 12, 2024  
DOI:10.3760/cma.j.cn112338-20240712-00419
KeyWord: 疫苗  孕妇免疫  临床研究
English Key Word: Vaccine  Maternal immunization  Clinical studies
FundProject: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)
Author NameAffiliationE-mail
Liu Yue School of Public Health, Southeast University, Nanjing 210009, China  
Jia Siyue 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  
Ma Xinmo School of Public Health, Southeast University, Nanjing 210009, China  
Wen Feng School of Public Health, Southeast University, Nanjing 210009, China  
Zhu Fengcai 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 jszfc@vip.sina.com 
Li Jingxin School of Public Health, Southeast University, Nanjing 210009, China jingxin42102209@126.com 
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Abstract:
      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。
English Abstract:
      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.
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