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

ABSTRACTThe 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-...

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Main Authors: Yutong Zhang, Jinzhao Cui, Fengfeng Liu, Yang Song, Quanyi Wang, Yanzhe Liu, Yanping Zhang, Zhongjie Li, Zhaorui Chang
Format: Article
Language:English
Published: Taylor & Francis Group 2024-12-01
Series:Human Vaccines & Immunotherapeutics
Subjects:
Online Access:https://www.tandfonline.com/doi/10.1080/21645515.2024.2330163
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author Yutong Zhang
Jinzhao Cui
Fengfeng Liu
Yang Song
Quanyi Wang
Yanzhe Liu
Yanping Zhang
Zhongjie Li
Zhaorui Chang
author_facet Yutong Zhang
Jinzhao Cui
Fengfeng Liu
Yang Song
Quanyi Wang
Yanzhe Liu
Yanping Zhang
Zhongjie Li
Zhaorui Chang
author_sort Yutong Zhang
collection DOAJ
description ABSTRACTThe 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 (p < .001). The overall VEadj was estimated to be 90.8%. The VEadj estimates for partially and fully vaccinated children were 90.1% and 90.9%, respectively. Stratified by age group, the VEadj estimates were 88.7% for 6 to 35-month-olds and 95.5% for 36 to 71-month-olds. Regarding disease severity, the VEadj estimates were 86.3% for mild cases and 100% for severe cases. Sensitivity analysis showed minimal changes in the VE point estimates, with most changing by no more than 1% point. Our study demonstrates a high level of vaccine effectiveness against EV-A71-HFMD, especially in severe cases. Active promotion of EV-A71 vaccination is an effective strategy in preventing EV-A71 infections.
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spelling doaj.art-d806a3cea00f46e2ac44a4efcbece4e32024-03-28T06:19:37ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2024-12-0120110.1080/21645515.2024.2330163Effectiveness of Enterovirus 71 inactivated vaccines against hand, foot, and mouth disease: A test-negative case-control studyYutong Zhang0Jinzhao Cui1Fengfeng Liu2Yang Song3Quanyi Wang4Yanzhe Liu5Yanping Zhang6Zhongjie Li7Zhaorui Chang8Division of Infectious Disease, National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, Chinese Center for Disease Control and Prevention, Beijing, ChinaDivision of Infectious Disease, National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, Chinese Center for Disease Control and Prevention, Beijing, ChinaDivision of Infectious Disease, National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, Chinese Center for Disease Control and Prevention, Beijing, ChinaDivision of Infectious Disease, National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, Chinese Center for Disease Control and Prevention, Beijing, ChinaInstitute for the Control of Infectious and Endemic Diseases, Beijing Center for Disease Prevention and Control, Beijing, ChinaDivision of Infectious Disease, National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, Chinese Center for Disease Control and Prevention, Beijing, ChinaDivision of Infectious Disease, National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, Chinese Center for Disease Control and Prevention, Beijing, ChinaPeking Union Medical College, Chinese Academy of Medical Sciences, Beijing, ChinaDivision of Infectious Disease, National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, Chinese Center for Disease Control and Prevention, Beijing, ChinaABSTRACTThe 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 (p < .001). The overall VEadj was estimated to be 90.8%. The VEadj estimates for partially and fully vaccinated children were 90.1% and 90.9%, respectively. Stratified by age group, the VEadj estimates were 88.7% for 6 to 35-month-olds and 95.5% for 36 to 71-month-olds. Regarding disease severity, the VEadj estimates were 86.3% for mild cases and 100% for severe cases. Sensitivity analysis showed minimal changes in the VE point estimates, with most changing by no more than 1% point. Our study demonstrates a high level of vaccine effectiveness against EV-A71-HFMD, especially in severe cases. Active promotion of EV-A71 vaccination is an effective strategy in preventing EV-A71 infections.https://www.tandfonline.com/doi/10.1080/21645515.2024.2330163Enterovirus A71Enterovirus A71 inactivated vaccinevaccine effectivenesstest negative designhand, foot, and mouth disease
spellingShingle Yutong Zhang
Jinzhao Cui
Fengfeng Liu
Yang Song
Quanyi Wang
Yanzhe Liu
Yanping Zhang
Zhongjie Li
Zhaorui Chang
Effectiveness of Enterovirus 71 inactivated vaccines against hand, foot, and mouth disease: A test-negative case-control study
Human Vaccines & Immunotherapeutics
Enterovirus A71
Enterovirus A71 inactivated vaccine
vaccine effectiveness
test negative design
hand, foot, and mouth disease
title Effectiveness of Enterovirus 71 inactivated vaccines against hand, foot, and mouth disease: A test-negative case-control study
title_full Effectiveness of Enterovirus 71 inactivated vaccines against hand, foot, and mouth disease: A test-negative case-control study
title_fullStr Effectiveness of Enterovirus 71 inactivated vaccines against hand, foot, and mouth disease: A test-negative case-control study
title_full_unstemmed Effectiveness of Enterovirus 71 inactivated vaccines against hand, foot, and mouth disease: A test-negative case-control study
title_short Effectiveness of Enterovirus 71 inactivated vaccines against hand, foot, and mouth disease: A test-negative case-control study
title_sort effectiveness of enterovirus 71 inactivated vaccines against hand foot and mouth disease a test negative case control study
topic Enterovirus A71
Enterovirus A71 inactivated vaccine
vaccine effectiveness
test negative design
hand, foot, and mouth disease
url https://www.tandfonline.com/doi/10.1080/21645515.2024.2330163
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