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. 2019;15(5):1183-1190.
doi: 10.1080/21645515.2019.1581539. Epub 2019 Mar 20.

Enterovirus A71 vaccine effectiveness in preventing enterovirus A71 infection among medically-attended hand, foot, and mouth disease cases, Beijing, China

Xiaoli Wang  1   2 , Zhijie An  1 , Da Huo  2 , Lei Jia  2 , Jie Li  2 , Yang Yang  2 , Zhichao Liang  2 , Quanyi Wang  2 , Huaqing Wang  1
Affiliations

Enterovirus A71 vaccine effectiveness in preventing enterovirus A71 infection among medically-attended hand, foot, and mouth disease cases, Beijing, China

Xiaoli Wang et al. Hum Vaccin Immunother. 2019.

Abstract

Introduction: Enterovirus A71(EV-A71)-associated hand, foot, and mouth disease (HFMD) has been reported worldwide, and poses a particularly heavy burden on patients, families, and society in China. Three Chinese companies have licensed inactivated EV-A71 vaccines, all of which have demonstrated good efficacy for preventing EV-A71-associated disease in clinical trials. However, real-world performance of EV-A71 vaccine has not been evaluated.

Methods: We used a test-negative design case-control study to estimate vaccine effectiveness (VE) against medically attended EV-A71-associated HFMD. Subjects were children 5 years of age and under who had been in health facilities participating in the HFMD case and virologic surveillance platforms in Beijing. Enterovirus infections were laboratory confirmed, and EV-A71 vaccination status was extracted from electronic immunization records. Children testing positive for EV-A71 were cases; controls were children testing negative for EV-A71 infection. Logistic regression was used to estimate VE. We assessed sensitivity of VE estimates to control group inclusion criteria by repeating the regression analyses with two alternative control groups.

Results: A total of 2,184 HFMD patients aged 5 years and under were enrolled in the study; 24 were severe, and 2,160 were mild. For severe cases, two-dose VE estimate was 100% (95% CI: -68.1%, 100%). For mild cases, 1-dose and 2-dose adjusted VE estimates were 69.8% and 83.7%, respectively. Two-dose VE estimates varied by less than 4 percentage points regardless of control group definition.

Conclusions: Our findings suggested the vaccines performed well in the real world for children 5 years of age and under in Beijing, China.

Keywords: Hand; and mouth disease; enterovirus infections; foot; inactivated vaccines.

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Figures

Figure 1.
Figure 1.
Flow chart of subject enrollment in the test-negative design case-control study for the estimates of EV-A71 vaccine effectiveness during 2017, in Beijing, China. Note: HFMD: hand, foot, and mouth disease. EV-A71: enterovirus A71. BMSIIP: Beijing Management System of Information for the Immunization Program. VE: vaccine effectiveness.
Figure 2.
Figure 2.
Monthly number of the cases testing negative and positive for enterovirus by serotype. Note: EV-A71: enterovirus A71. CV-A16: coxsackievirus A16. CV-A6: coxsackievirus A6. Others: otherenterovirus than EV-A71, CV-A16 and CV-A6. Negative: negative for all enteroviruses.
Figure 3.
Figure 3.
Timeline of number of subjects receiving two doses of EV-A71 vaccine. Note: EV-A71: enterovirus A71. The number of subjects who received EV-A71 vaccine were excluded: (1) who only received one dose of EV-A71 vaccine, and (2) who received a second dose of EV-A71 vaccine that was <28 days before the illness onset.
Figure 4.
Figure 4.
Phylogentic analysis of VP1 gene of EV-A71 strains from HFMD virological surveillance during the 2016–2017 in Beijing, China#. Note: EV-A71: enterovirus A71.HFMD: hand, foot, and mouth disease.# The EV-A71 strains analyzed in this study were indicated with solid triangles and squares, and the vaccine strains were shown with solid dots. ▲the strains isolated in 2016, ■ the strains isolated in 2017; ● vaccine strains
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Grants and funding

This work was supported by Beijing Excellent Talent Training Project of Beijing Municipal Committee Organization Department (grant number 2016000021469G184) and the Central finance- operation of public health emergency response mechanism of Chinese Center for Disease Control and Prevention (grant number 131031001000150001).

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