Effectiveness of Enterovirus 71 inactivated vaccines against hand, foot, and mouth disease: A test-negative case-control study

• Published in: Human vaccines & immunotherapeutics 2024-12, Vol.20 (1), p.2330163
• Main Authors: Zhang, Yutong, Cui, Jinzhao, Liu, Fengfeng, Song, Yang, Wang, Quanyi, Liu, Yanzhe, Zhang, Yanping, Li, Zhongjie, Chang, Zhaorui
• Format: Article
• Language: English
• Subjects: Antigens, Viral; Case-Control Studies; Child; China - epidemiology; Enterovirus; Enterovirus A, Human; Enterovirus A71; Enterovirus A71 inactivated vaccine; Enterovirus Infections; Hand, Foot and Mouth Disease - prevention & control; hand, foot, and mouth disease; Humans; test negative design; vaccine effectiveness; Vaccine Safety; Vaccines, Inactivated
• ISSN: 2164-5515; 2164-554X; 2164-554X
• DOI: 10.1080/21645515.2024.2330163

The Enterovirus A71 (EV-A71) vaccine was introduced in China in December 2015 as a preventive measure against hand, foot, and mouth disease (HFMD) caused by EV-A71. However, the effectiveness of the vaccine (VE) in real-world settings needs to be evaluated. We conducted a test-negative case-control study to assess the effectiveness of EV-A71 vaccines in preventing EV-A71-associated HFMD. Children aged 6-71 months with HFMD were enrolled as participants. The case group comprised those who tested positive for EV-A71, while the control group comprised those who tested negative for EV-A71. To estimate VE, a logistic regression model was employed, adjusting for potential confounders including age, gender, and clinical severity. In total, 3223 children aged 6 to 71 months were included in the study, with 162 in the case group and 3061 in the control group. The proportion of children who received EV-A71 vaccination was significantly lower in the case group compared to the control group (