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      Epidemiologic Features of Enterovirus 71-Associated Hand-Foot-and-Mouth Disease from 2009 to 2013 in Zhejiang, China

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          Abstract

          Enterovirus 71 (EV71) usually causes hand-foot-and-mouth disease (HFMD) with severe clinical symptoms and even deaths in China. There is no efficient antiviral drug to protect against severe EV71-associated HFMD, making the development of EV71 vaccines therefore a priority. However, the potential target subject population(s) to be immunized with EV71 vaccine are not well understood. In this study, we characterized the epidemiology regarding EV71-associated HFMD on the basis of provincial-level surveillance. We extracted data on EV71-associated HFMD from the National Notifiable Disease Reporting System in Zhejiang Province, China between 1 January 2009 and 31 December 2013 ( n = 7650). The higher incidence rate of EV71 cases occurred in those children aged 12–23 months, with boys being predominant. Interestingly, different peaks activities of EV71 infection was observed in different calendar year, with one peak in 2009 and 2013 and two peaks in 2010–2012. However, EV71 infection seemed to predominately occur in warm season and a distinguished cyclic peak that seemed to be of about 12 months. Children aged 12–23 months are thus identified as an important target population for public health intervention, for example, it is recommended that these key subjects immunized with EV71 vaccine. In addition, an enhanced surveillance system for EV71-associated with HFMD needs to focus on generic and phylogenetic analysis.

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          Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China.

          Enterovirus 71 (EV71) is one of the major causative agents of outbreaks of hand, foot, and mouth disease or herpangina worldwide. This phase 3 trial was designed to evaluate the efficacy, safety, and immunogenicity of an EV71 vaccine. We conducted a randomized, double-blind, placebo-controlled, multicenter trial in which 10,007 healthy infants and young children (6 to 35 months of age) were randomly assigned in a 1:1 ratio to receive two intramuscular doses of either EV71 vaccine or placebo, 28 days apart. The surveillance period was 12 months. The primary end point was the occurrence of EV71-associated hand, foot, and mouth disease or herpangina. During the 12-month surveillance period, EV71-associated disease was identified in 0.3% of vaccine recipients (13 of 5041 children) and 2.1% of placebo recipients (106 of 5028 children) in the intention-to-treat cohort. The vaccine efficacy against EV71-associated hand, foot, and mouth disease or herpangina was 94.8% (95% confidence interval [CI], 87.2 to 97.9; P<0.001) in this cohort. Vaccine efficacies against EV71-associated hospitalization (0 cases vs. 24 cases) and hand, foot, and mouth disease with neurologic complications (0 cases vs. 8 cases) were both 100% (95% CI, 83.7 to 100 and 42.6 to 100, respectively). Serious adverse events occurred in 111 of 5044 children in the vaccine group (2.2%) and 131 of 5033 children in the placebo group (2.6%). In the immunogenicity subgroup (1291 children), an anti-EV71 immune response was elicited by the two-dose vaccine series in 98.8% of participants at day 56. An anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71-associated hand, foot, and mouth disease or herpangina. 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.).
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            An inactivated enterovirus 71 vaccine in healthy children.

            Enterovirus 71 (EV71) is a major cause of hand, foot, and mouth disease in children and may be fatal. A vaccine against EV71 is needed. We conducted a randomized, double-blind, placebo-controlled phase 3 trial involving healthy children 6 to 71 months of age in Guangxi Zhuang Autonomous Region, China. Two doses of an inactivated EV71 vaccine or placebo were administered intramuscularly, with a 4-week interval between doses, and children were monitored for up to 11 months. The primary end point was protection against hand, foot, and mouth disease caused by EV71. A total of 12,000 children were randomly assigned to receive vaccine or placebo. Serum neutralizing antibodies were assessed in 549 children who received the vaccine. The seroconversion rate was 100% 4 weeks after the two vaccinations, with a geometric mean titer of 170.6. Over the course of two epidemic seasons, the vaccine efficacy was 97.4% (95% confidence interval [CI], 92.9 to 99.0) according to the intention-to-treat analysis and 97.3% (95% CI, 92.6 to 99.0) according to the per-protocol analysis. Adverse events, such as fever (which occurred in 41.6% of the participants who received vaccine vs. 35.2% of those who received placebo), were significantly more common in the week after vaccination among children who received the vaccine than among those who received placebo. The inactivated EV71 vaccine elicited EV71-specific immune responses and protection against EV71-associated hand, foot, and mouth disease. (Funded by the National Basic Research Program and others; ClinicalTrials.gov number, NCT01569581.).
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              Phylogenetic analysis of enterovirus 71 strains isolated during linked epidemics in Malaysia, Singapore, and Western Australia.

              Enterovirus 71 (EV71) is a frequent cause of hand, foot, and mouth disease (HFMD) epidemics associated with severe neurological sequelae in a small proportion of cases. There has been a significant increase in EV71 epidemic activity throughout the Asia-Pacific region since 1997. Recent HFMD epidemics in this region have been associated with a severe form of brainstem encephalitis associated with pulmonary edema and high case fatality rates. In this study, we show that four genetic lineages of EV71 have been prevalent in the Asia-Pacific region since 1997, including two previously undescribed genogroups (B3 and B4). Furthermore, we show that viruses belonging to genogroups B3 and B4 have circulated endemically in Southeast Asia during this period and have been the primary cause of several large HFMD or encephalitis epidemics in Malaysia, Singapore, and Western Australia.
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                Author and article information

                Contributors
                Role: Academic Editor
                Journal
                Int J Environ Res Public Health
                Int J Environ Res Public Health
                ijerph
                International Journal of Environmental Research and Public Health
                MDPI
                1661-7827
                1660-4601
                30 December 2016
                January 2017
                : 14
                : 1
                : 33
                Affiliations
                [1 ]Department of Immunization Programme, Zhejiang Provincial Center for Disease Control and Prevention, 3399 Binsheng Road, Hangzhou 310051, China; zfwang@ 123456cdc.zj.cn (Z.W.); hklv@ 123456cdc.zj.cn (H.L.)
                [2 ]Department of Environmental and Occupational Health, Zhejiang Provincial Center for Disease Control and Prevention, 3399 Binsheng Road, Hangzhou 310051, China; wmzhu@ 123456cdc.zj.cn (W.Z.); zhmo@ 123456cdc.zj.cn (Z.M.)
                [3 ]Key Medical Research Center, Zhejiang Provincial Center for Disease Control and Prevention, 3399 Binsheng Road, Hangzhou 310051, China
                [4 ]Department of Science and Technology Information, Zhejiang Provincial Center for Disease Control and Prevention, 3399 Binsheng Road, Hangzhou 310051, China
                Author notes
                [* ]Correspondence: gmmao@ 123456cdc.zj.cn (G.M.); xfwang@ 123456cdc.zj.cn (X.W.); xmlou@ 123456cdc.zj.cn (X.L.); ydchen@ 123456cdc.zj.cn (Y.C.); Tel.: +86-571-8711-5224 (G.M.); +86-571-8711-5222 (X.W.); +86-571-8711-5219 (X.L.); +86-571-8711-5104 (Y.C.)
                Article
                ijerph-14-00033
                10.3390/ijerph14010033
                5295284
                28042848
                60f78dbf-5659-4f69-86fb-0bc132d8b50a
                © 2016 by the authors; licensee MDPI, Basel, Switzerland.

                This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC-BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 10 November 2016
                : 25 December 2016
                Categories
                Article

                Public health
                enterovirus 71,hand-foot-and-mouth disease,epidemiology,surveillance
                Public health
                enterovirus 71, hand-foot-and-mouth disease, epidemiology, surveillance

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