Division of Infectious Disease, National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, Chinese Center for Disease Control and Prevention, Beijing, China.
Institute for the Control of Infectious and Endemic Diseases, Beijing Center for Disease Prevention and Control, Beijing, China.
Hum Vaccin Immunother. 2024 Dec 31;20(1):2330163. doi: 10.1080/21645515.2024.2330163. Epub 2024 Mar 27.
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 ( < .001). The overall VE was estimated to be 90.8%. The VE estimates for partially and fully vaccinated children were 90.1% and 90.9%, respectively. Stratified by age group, the VE estimates were 88.7% for 6 to 35-month-olds and 95.5% for 36 to 71-month-olds. Regarding disease severity, the VE 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.
肠道病毒 A71（EV-A71）疫苗于 2015 年 12 月在中国推出，作为预防由 EV-A71 引起的手足口病（HFMD）的措施。然而，需要评估疫苗在真实环境中的效果（VE）。我们进行了一项病例对照研究，以评估 EV-A71 疫苗预防 EV-A71 相关 HFMD 的效果。纳入年龄为 6-71 个月的 HFMD 患儿作为参与者。病例组包括 EV-A71 检测阳性的患儿，对照组包括 EV-A71 检测阴性的患儿。为了估计 VE，我们采用逻辑回归模型，调整了年龄、性别和临床严重程度等潜在混杂因素。共有 3223 名年龄为 6-71 个月的儿童纳入研究，病例组 162 例，对照组 3061 例。与对照组相比，病例组接受 EV-A71 疫苗接种的儿童比例显著较低（<0.001）。总体 VE 估计为 90.8%。部分和完全接种疫苗的儿童的 VE 估计值分别为 90.1%和 90.9%。按年龄组分层，6-35 月龄儿童的 VE 估计值为 88.7%，36-71 月龄儿童的 VE 估计值为 95.5%。关于疾病严重程度，VE 估计值为轻症病例 86.3%，重症病例 100%。敏感性分析显示 VE 点估计值变化很小，大多数变化不超过 1%点。我们的研究表明，EV-A71-HFMD 疫苗具有很高的效果，特别是在重症病例中。积极推广 EV-A71 疫苗接种是预防 EV-A71 感染的有效策略。
