Efficacy, Safety, and Immunogenicity of an Enterovirus 71 Vaccine in China

Zhu, Fengcai; Xu, Wenbo; Xia, Jielai; Liang, Zhenglun; Liu, Yan; Zhang, Xuefeng; Tan, Xiaojuan; Wang, Ling; Mao, Qunying; Wu, Junyu; Hu, Yuemei; Ji, Tianjiao; Song, Li-Fei; Qi, Liang; Zhang, Baomin; Gao, Qiang; Li, Jingxin; Wang, Shenyu; Hu, Yuansheng; Gu, Shanru; Zhang, Jianhua; Yao, Genhong; Gu, Jianxiang; Wang, Xushan; Zhou, Yuchun; Chen, Changbiao; Zhang, Minglei; Cao, Minquan; Wang, Junzhi; Wang, Hua; Wang, Nan

doi:10.1056/nejmoa1304923

Cited by 384 publications

(291 citation statements)

References 24 publications

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“…Three biological product companies have completed the phase III clinical trial of EV71 inactivated vaccine and the results show that the vaccine is safe and effective. 23,32,33 Our findings suggest that more financial resources should be invested toward the prevention and management of EV71-associated disease, especially the severe HFMD. The department of health administration and government should reduce the disease burden of patients through various measures such as improving medical cost reimbursement, optimizing methods for diagnosis or treatment of EV71-associated disease.…”

Section: Discussionmentioning

confidence: 86%

See 1 more Smart Citation

Disease burden of enterovirus 71 in rural central China: A community-based survey

Gan¹,

Jin²,

et al. 2015

Human Vaccines & Immunotherapeutics

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Section: Discussionmentioning

confidence: 86%

“…23,33 The surveillance and definition of EV71-associated disease was referred to in these trials. We investigated 343 cases due to EV71 infection, which were reported between 2011 and 2013 by the Ganyu and Sheyang prefecture Centers for Disease Control and Prevention.…”

Section: Methodsmentioning

confidence: 99%

Disease burden of enterovirus 71 in rural central China: A community-based survey

Gan¹,

Jin²,

et al. 2015

Human Vaccines & Immunotherapeutics

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“…However efforts have been initiated to develop a vaccine against specific EVs most notably EV-71 (Liang and Wang, 2014;Lu, 2014;Zhu et al, 2014). …”

Section: Poliomyelitis Vaccination and Eradication Updatementioning

confidence: 99%

Polioviruses and other Enteroviruses

Betancourt¹,

Shulman²

2019

Water and Sanitation for the 21st Century: Health and Microbiological Aspects of Excreta and Wastewater Management (Global Wate

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“…8,9 Currently, 3 inactivated EV71 vaccines developed in China have demonstrated good efficacy and safety profile in the phase 3 clinical trials. [10][11][12] These 3 EV71 vaccines are very likely to be the first available vaccines against EV71-associated disease in the world.…”

Section: Introductionmentioning

confidence: 99%

“…In two of the 3 trials, 10,12 correlate of immunity againstEV71-associated disease was explored by applying a receiver operating characteristics (ROC) curve analysis in a subset of cohort selected by matching each case with 5 controls. The results suggested that antibody titers of 1:16-1:32 with the maximum Youden index might be a possible serologic marker for protection against EV71-associated disease.…”

Section: Introductionmentioning

confidence: 99%

Validation and evaluation of serological correlates of protection for inactivated enterovirus 71 vaccine in children aged 6-35 months

Jin

Zhang

et al. 2016

Human Vaccines & Immunotherapeutics

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Background: A primary goal of this study was to establish the serological mechanistic correlate of protection (mCoP) for an inactivated Enterovirus 71 (EV71) vaccine. Methods: We used the Prentice criterion framework and scaled logit model to explore the relationship between the neutralizing antibody (NTAb) and EV71-associated disease, and to build a protection curve for estimating the efficacy of EV71 vaccine. Data of NTAb at day 56 post-vaccination and the occurrence of EV71-associated disease during a 12-month follow-up period were collected from a phase 3 efficacy trial of EV71 vaccine in this study.Results: NTAb at day 56 post-vaccination in participants met the Prentice criterion framework. According to the protection curve, the antibody levels of 14.7, 27.8, 55.7, 129.0 and 459.4 (U/mL) were associated with 50%, 60%, 70%, 80% and 90% clinical protection rate, respectively. Vaccine efficacy predicted by the model was 81.5%, which was very similar to the actual vaccine efficacy of 80.4% (95% CI, 58.2, 90.8) observed in the phase 3 trial. Conclusions: NTAb titers post-vaccination can be validated as mCoP for evaluating the efficacy of an inactivated enterovirus 71 vaccine, with a titers of 14.7 (U/ml) as a surrogate associated with the protection of 50% against EV71-associated disease.

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Efficacy, Safety, and Immunogenicity of an Enterovirus 71 Vaccine in China

Abstract: The EV71 vaccine provided protection against EV71-associated hand, foot, and mouth disease or herpangina in infants and young children. (Funded by Sinovac Biotech; ClinicalTrials.gov number, NCT01507857.).

Cited by 384 publications

References 24 publications

Disease burden of enterovirus 71 in rural central China: A community-based survey

Disease burden of enterovirus 71 in rural central China: A community-based survey

Polioviruses and other Enteroviruses

Validation and evaluation of serological correlates of protection for inactivated enterovirus 71 vaccine in children aged 6-35 months

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