Effectiveness of enterovirus A71 vaccine in severe hand, foot, and mouth disease cases in Guangxi, China
Effectiveness of enterovirus A71 vaccine in severe hand, foot, and mouth disease cases in Guangxi, China
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DOI：
10.1016/j.vaccine.2019.12.025
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发表时间：
2020-02-11
期刊：
影响因子：
5.5
通讯作者：
Ning, Chuanyi
中科院分区：
文献类型：
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作者：
Jiang, Lina;Wang, Jing;Ning, Chuanyi
背景资料：由肠道病毒A71（EV-A71）引起的手足口病（HFMD）是中国的一个重大公共卫生问题，对儿童，特别是3岁以下儿童的健康构成严重威胁。自2016年以来，已有三家中国制造商开发的EV 71疫苗获批使用，这些疫苗的临床试验证明了对EV-A71感染的保护作用。然而，很少有研究评估这些疫苗在现实世界settings.Methods的有效性：一个测试阴性设计的病例对照研究，用于估计疫苗的有效性（VE）在严重的手足口病的情况下。我们从当地疾病预防控制中心（CDC）获得了2017年1月1日至2018年12月31日中国广西所有12岁以下重症手足口病病例的EV-A71疫苗接种情况等信息。肠道病毒感染经当地CDC实验室确认。EV-A71核酸检测结果阳性的个体被分配到病例组，EV-A71核酸检测结果阴性的个体被分配到对照组。结果：共纳入2779例重症手足口病患儿，其中EV-A71阳性患儿838例，EV-A71阴性对照患儿1941例。6-36月龄EV-A71阳性病例比例低于EV-A71阴性对照。EV-A71感染与死亡风险增加相关（aOR，8.8; 95%CI，1.3-61.6）。结论：EV-A71在广西手足口病重症病例中的感染率有所下降，6-36月龄儿童EV-A71感染的风险降低。灭活疫苗在现实世界中的严重手足口病病例中表现良好。(C)2019爱思唯尔有限公司发布
Background: Hand, foot, and mouth disease (HFMD) caused by enterovirus A71 (EV-A71) is a major public health issue in China that poses severe risks to children's health, especially those under the age of 3. Since 2016, EV71 vaccines developed by three Chinese manufacturers have been approved for use, and clinical trials of these vaccines have demonstrated protection against EV-A71 infection. However, few studies have assessed the effectiveness of these vaccines in real-world settings.Methods: A test-negative design case-control study was used to estimate vaccine effectiveness (VE) in cases of severe HFMD. We obtained information including EV-A71 vaccination status from the Local Center for Disease Control and Prevention (CDC) on all severe HFMD cases under 12 years in age in Guangxi, China, from Jan. 1, 2017, to Dec. 31, 2018. Enterovirus infection was laboratory confirmed by local CDCs. Individuals with a positive EV-A71 nucleic acid test result were assigned to the case group, and those with negative EV-A71 nucleic acid test results were assigned to the control group. We estimated VE using logistic regression.Results: A total of 2779 severe HFMD cases were enrolled in the study; 838 children were EV-A71 positive cases, and 1941 children were EV-A71 negative controls. The proportion of EV-A71 positive cases aged 6-36 months was lower than that for EV-A71 negative controls. EV-A71 infection was associated with an increased risk of mortality (aOR, 8.8; 95% CI, 1.3-61.6). The adjusted VE was 81.4% and 88.3% for one dose and two doses, respectively.Conclusion: Our findings suggest that the rate of EV-A71 has fallen among severe HFMD cases in Guangxi and that the risk for EV-A71 infection in 6-36-month-old children has been reduced by use of the vaccine. Inactivated vaccines performed well in severe HFMD cases in a real-world setting. (C) 2019 Published by Elsevier Ltd.