Clinical research design and application of vaccines based on maternal immunization

Maternal immunization is a highly effective public health strategy. It is the administration of vaccines to pregnant women that increase 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 and COVID-19 have been widely used around the world, 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 trial, cohort study, case-control study and surveillance data study. It summarizes the strengths and weaknesses of different study approaches and discusses the application prospect of maternal immunization strategy in order to provide reference for the development of maternal immunization research in China.