2,692
Views
62
CrossRef citations to date
0
Altmetric
Reviews

EV-A71 vaccine licensure: a first step for multivalent enterovirus vaccine to control HFMD and other severe diseases

, , , &
Pages 1-7 | Received 29 Jan 2016, Accepted 02 May 2016, Published online: 25 Jan 2019

  • FauquetCM,MayoMA,ManiloffJet al.Virus Taxonomy, Eighth Report of the International Committee on Taxonomy of Viruses.Elsevier Academic Press: San Diego.2005,757–778.
  • MirandA,HenquellC,ArchimbaudCet al.Outbreak of hand, foot and mouth disease/herpangina associated with coxsackievirus A6 and A10 infections in 2010, France: a large citywide, prospective observational study.Clin Microbiol Infect2012; 18:E110–E118.
  • MaoQ,WangY,YaoXet al.Coxsackievirus A16: epidemiology, diagnosis, and vaccine.Hum Vaccin Immunother2014; 10:360–367.
  • YipCC,LauSK,WooPCet al.Human enterovirus 71 epidemics: what’s next?Emerg Health Threats J2013; 6:19780.
  • ChenYJ,ChangSC,TsaoKCet al.Comparative genomic analysis of coxsackievirus A6 strains of different clinical disease entities.PLoS One2012; 7:e52432.
  • FujimotoT,IizukaS,EnomotoMet al.Hand, foot, and mouth disease caused by coxsackievirus A6, Japan, 2011.Emerg Infect Dis2012; 18:337–339.
  • PuenpaJ,ChieochansinT,LinsuwanonP.Hand, foot, and mouth disease caused by coxsackievirus A6, Thailand, 2012.Emerg Infect Dis2013; 19:641–643.
  • LiJL,YuanJ,YangFet al.Epidemic characteristics of hand, foot, and mouth disease in southern China, 2013: coxsackievirus A6 has emerged as the predominant causative agent.J Infect2014; 69:299–303.
  • YangQ,DingJ,CaoJet al.Epidemiological and etiological characteristics of hand, foot, and mouth disease in Wuhan, China from 2012 to 2013: outbreaks of coxsackieviruses A10.J Med Virol2015; 87:954–960.
  • NiH,YiB,YinJet al.Epidemiological and aetiological characteristics of hand, foot and mouth disease in Ningbo, China, 2008-2011.J Clin Virol2012; 54:342–348.
  • TianH,ZhangY,SunQet al.Prevalence of multiple enteroviruses associated with hand, foot, and mouth disease in Shijiazhuang City, Hebei province, China: outbreaks of coxsackieviruses a10 and b3.PLoS One2014; 9:e84233.
  • KimDS,NamJH.Characterization of attenuated coxsackievirus B3 strains and prospects of their application as live-attenuated vaccines.Expert Opin Biol Ther2010; 10:179–190.
  • KimHJ,KangB,HwangSet al.Epidemics of viral meningitis caused by echovirus 6 and 30 in Korea in 2008.Virol J2012; 9:38.
  • China Food and Drug AdministrationCFDA PIZHUN CHANGDAO BINGDU 71XING MIEHUOYIMIAO SHENGCHAN SHANGSHI. Chinese.CFDA: Beijing.2015.Available athttp://www.sfda.gov.cn/WS01/CL0051/136853.html (accessed on 27 January 2016).
  • China Food and Drug AdministrationCFDA PIZHUN SHANGSHIYAOPIN GONGGAO. Chinese.CFDA: Beijing.2016.Available athttp://www.sda.gov.cn/WS01/CL0087/142000.html (accessed on 27 January 2016).
  • CaiY,KuZ,LiuQet al.A combination vaccine comprising of inactivated enterovirus 71 and coxsackievirus A16 elicits balanced protective immunity against both viruses.Vaccine2014; 32:2406–2412.
  • KuZ,LiuQ,YeXet al.A virus-like particle based bivalent vaccine confers dual protection against enterovirus 71 and coxsackievirus A16 infections in mice.Vaccine2014; 32:4296–4303.
  • BianL,WangY,YaoXet al.Coxsackievirus A6: a new emerging pathogen causing hand, foot and mouth disease outbreaks worldwide.Expert Rev Anti Infect Ther2015; 13:1061–1071.
  • AngLW,KohBK,ChanKPet al.Epidemiology and control of hand, foot and mouth disease in Singapore, 2001-2007.Ann Acad Med Singapore2009; 28:106–112.
  • LinsuwanonP,PuenpaJ,HuangSWet al.Epidemiology and seroepidemiology of human enterovirus 71 among Thai populations.J Biomed Sci2014; 21:16.
  • LiuSL,PanH,LiuPet al.Comparative epidemiology and virology of fatal and nonfatal cases of hand, foot and mouth disease in mainland China from 2008 to 2014.Rev Med Virol2015; 25:115–128.
  • XingW,LiaoQ,ViboudCet al.Hand, foot and mouth disease in China, 2008-12: an epidemiological study.Lancet Infect Dis2014; 14:308–318.
  • RobinsonCR,DoaneFW,RhodesAJ.Report of an outbreak of febrile illness with pharyngeal lesions and exanthem: Toronto, summer 1957; isolation of group A Coxsackie virus.Can Med Assoc J1958; 79:615–621.
  • FersonMJ,BellSM.Outbreak of coxsackievirus A16 hand, foot, and mouth disease in a child day-care center.Am J Public Health1991; 81:1675–1676.
  • BendigJW,FlemingDM.Epidemiological, virological, and clinical features of an epidemic of hand, foot, and mouth disease in England and Wales.Commun Dis Rep CDR Rev1996; 6:R81–R86.
  • ChangLY.Enterovirus 71 in Taiwan.Pediatr Neonatol2008; 49:103–112.
  • TuPV,ThaoNTT,PereraDet al.Epidemiologic and virologic investigation of hand, foot and mouth disease, Southern Vietnam, 2005.Emerg Infect Dis2007; 13:1733–1741.
  • KarBR,DwibediB,KarSK.An outbreak of hand, foot and mouth disease in Bhubaneswar, Odisha.Indian Pediatr2013; 50:139–142.
  • WangCY,Li LuF,WuMHet al.Fatal coxsackievirus A16 infection.Pediatr Infect Dis J2004; 23:275–276.
  • WuY,YeoA,PhoonMCet al.The largest outbreak of hand, foot and mouth disease in Singapore in 2008: the role of enterovirus71 and coxsackievirus A strains.Int J Infect Dis2010; 14:e1076.
  • MontesM,ArtiedaJ,PiñeiroLDet al.Hand, foot, and mouth disease outbreak and coxsackievirus A6, northern Spain, 2011.Emerg Infect Dis2013; 19:676–678.
  • PuenpaJ,MauleekoonphairojJ,LinsuwanonPet al.Prevalence and characterization of enterovirus infections among pediatric patients with hand foot mouth disease, herpangina and influenza like illness in Thailand, 2012.PLoS One2014; 9:e98888.
  • Centers for Disease Control and Prevention (CDC).Notes from the field: severe hand, foot, and mouth disease associated with coxsackievirus A6–Alabama, Connecticut, California, and Nevada, November 2011-February 2012.MMWR Morb Mortal Wkly Rep2012; 61:213–214.
  • SinclairC,GauntE,SimmondsPet al.Atypical hand, foot, and mouth disease associated with coxsackievirus A6 infection, Edinburgh, United Kingdom, January to February 2014.Euro Surveill2014; 19:20745.
  • KimDS,NamJH.Application of attenuated coxsackievirus B3 as a viral vector system for vaccines and gene therapy.Hum Vaccin2011; 7:410–416.
  • BaekK,ParkK,JungEet al.Molecular and epidemiological characterization of enteroviruses isolated in Chungnam, Korea from 2005 to 2006.J Microbiol Biotechnol2009; 19:1055–1064.
  • BaekK,YeoS,LeeBet al.Epidemics of enterovirus infection in Chungnam Korea, 2008 and 2009.Virol J2011; 8:297.
  • ShahVA,ChongCY,ChanKPet al.Clinical characteristics of an outbreak of hand, foot and mouth disease in Singapore.Ann Acad Med Singapore2003; 32:381–387.
  • HsuCH,LuCY,ShaoPLet al.Epidemiologic and clinical features of non-polio enteroviral infections in northern Taiwan in 2008.J Microbiol Immunol Infect2011; 44:265–273.
  • YaoX,BianLL,LuWWet al.Enterovirus spectrum from the active surveillance of hand foot and mouth disease patients under the clinical trial of inactivated Enterovirus A71 vaccine in Jiangsu, China, 2012-2013.J Med Virol2015; 87:2009–2017.
  • ChenP,TaoZ,SongYet al.A coxsackievirus B5-associated aseptic meningitis outbreak in Shandong Province, China in 2009.J Med Virol2013; 85:483–489.
  • MooreM,KaplanMH,McPheeJet al.Epidemiologic, clinical, and laboratory features of Coxsackie B1-B5 infections in the United States, 1970-79.Public Health Rep1984; 99:515–522.
  • BaeEY,LeeEJ,HanSBet al.A case of myocarditis following neonatal meningitis caused by coxsackievirus B1 in spite of intravenous immunoglobulin treatment.J Trop Pediatr2014; 60:164–167.
  • TapparelC,SiegristF,PettyTJet al.Picornavirus and enterovirus diversity with associated human diseases.Infect Genet Evol2013; 14:282–293.
  • PeiYW,WangJX,LinYet al.Genetic analysis of Echovirus 30 isolated from hand-foot-mouth disease causes and healthy controls from Shandong, China in 2010.Chin J Viral Dis2013; 3:367–371.
  • ZhangT,DuJ,XueYet al.Epidemics and frequent recombination within species in outbreaks of human enterovirus B-associated hand,foot and mouth disease in Shandong China in 2010 and 2011.PLoS One2013; 8:e67157.
  • HeP,ChenC,DiBet al.Spectrum analysis of hand, foot and mouth disease in Guangzhou in 2011.J Trop Med2012; 12:613–616.
  • KumarA,ShuklaD,KumarRet al.Molecular identification of enteroviruses associated with aseptic meningitis in children from India.Arch Virol2013; 158:211–215.
  • MartinoTA,LiuP,SoleMJ.Viral infection and the pathogenesis of dilated cardiomyopathy.Circ Res1994; 74:182–188.
  • DumaidiK,FrantzidouF,PapaAet al.Enterovirus meningitis in Greece from 2003-2005: diagnosis, CSF laboratory findings, and clinical manifestations.J Clin Lab Anal2006; 20:177–183.
  • ZhuFC,MengFY,LiJXet al.Efficacy, safety, and immunology of an inactivated alum-adjuvant enterovirus 71 vaccine in children in China: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.Lancet2013; 381:2024–2032.
  • ChengA,FungCP,LiuCCet al.A phase I, randomized, open-label study to evaluate the safety and immunogenicity of an enterovirus 71 vaccine.Vaccine2013; 31:2471–2476.
  • National Institutes of HealthSafety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus 71. ClinicalTrials.gov Identifier: NCT01376479.NIH: USA.2015.Available athttps://prsinfo.clinicaltrial.gov/ct2/show/nct01376479?term=inviragen±%28singapore%29±pte±ltd.&rank=1%202013 (accessed 27 January 27 2016).
  • WuCY,LinYW,KuoCHet al.Inactivated enterovirus 71 vaccine produced by 200-L scale serum-free microcarrier bioreactor system provides cross-protective efficacy in human SCARB2 transgenic mouse.PLoS One2015; 10:e0136420.
  • AritaM,NagataN,IwataNet al.An attenuated strain of enterovirus 71 belonging to genotype A showed a broad spectrum of antigenicity with attenuated neurovirulence in cynomolgus monkeys.J. Virol2007; 81:9386–9395.
  • ChungYC,HoMS,WuJCet al.Immunization with virus-like particles of enterovirus 71 elicits potent immune responses and protects mice against lethal challenge.Vaccine2008; 26:1855–1862.
  • KuZ,YeX,HuangXet al.Neutralizing antibodies induced by recombinant virus-like particles of enterovirus 71 genotype C4 inhibit infection at pre- and post-attachment steps.PLoS One2013; 8:e57601.
  • LiuQ,ShiJ,HuangXet al.A murine model of coxsackievirus A16 infection for anti-viral evaluation.Antiviral Res2014; 105:26–31.
  • LiJ,LiuG,LiuXet al.Optimization and characterization of candidate strain for coxsackievirus A16 inactivated vaccine.Viruses2015; 7:3891–3909.
  • ShiJ,HuangX,LiuQet al.Identification of conserved neutralizing linear epitopes within the VP1 protein of coxsackievirus A16.Vaccine2013; 31:2130–2136.
  • ZhaoH,LiHY,HanJFet al.Virus-like particles produced in Saccharomyces cerevisiae elicit protective immunity against coxsackievirus A16 in mice.Appl Microbiol Biotechnol2013; 97:10445–10452.
  • GongM,ZhuH,ZhouJet al.Cryo-electron microscopy study of insect cell-expressed enterovirus 71 and coxsackievirus a16 virus-like particles provides a structural basis for vaccine development.J Virol2014; 88:6444–6452.
  • SomasundaramB,ChangC,FanYYet al.Characterizing enterovirus 71 and coxsackievirus A16 virus-like particles production in insect cells.Methods2016; 95:38–45.
  • ChenYJ,MengFY,MaoQet al.Clinical evaluation for batch consistency of an inactivated enterovirus 71 vaccine in a large-scale phase 3 clinicaltrial.Hum Vaccin Immunother2014; 10:1366–1372.
  • LiJX,SongYF,WangLet al.Two-year efficacy and immunogenicity of Sinovac enterovirus 71 vaccine against hand, foot and mouth disease in children.Expert Rev Vaccines2015; 15:129–137.
  • LiuL,MoZ,LiangZet al.Immunity and clinical efficacy of an inactivated enterovirus 71 vaccine in healthy Chinese children: a report of further observations.BMC Med2015; 13:226.
  • ZhuFC,LiangZL,LiXLet al.Immunogenicity and safety of an enterovirus 71 vaccine in healthy Chinese children and infants: a randomised, double-blind, placebo-controlled phase 2 clinical trial.Lancet2013; 381:1037–1045.
  • MaoQ,WangY,ShaoJet al.The compatibility of inactivated-enterovirus 71 vaccination with coxsackievirus A16 and Poliovirus immunizations in humans and animals.Hum Vaccin Immunother2015; 11:2723–2733.
  • LiangZ,MaoQ,GaoQet al.Establishing China’s national standards of antigen content and neutralizing antibody responses for evaluation of enterovirus 71 (EV71) vaccines.Vaccine2011; 29:9668–9674.
  • LiangZ,WangJ.EV71 vaccine, an invaluable gift for children.Clin Transl Immunology2014; 3:e28.
  • CaiY,LiuQ,HuangXet al.Active immunization with a coxsackievirus A16 experimental inactivated vaccine induces neutralizing antibodies and protects mice against lethal infection.Vaccine2013; 31:2215–2221.
  • Qi AnW,Guo SuZ,Wen PanRet al.The immunogenicity and protection effect of the BPL-inactivated CA16 vaccine in different animal systems.Hum Vaccin Immunother2014; 10:628–639.
  • YangE,ChengC,ZhangYet al.Comparative study of the immunogenicity in mice and monkeys of an inactivated CA16 vaccine made from a human diploid cell line.Hum Vaccin Immunother2014; 10:1266–1273.
  • SunS,JiangL,LiangZet al.Evaluation of monovalent and bivalent vaccines against lethal enterovirus 71 and coxsackievirus A16 infection in newborn mice.Hum Vaccin Immunother2014; 10:2885–2895.
  • LiuQ,TongX,HuangZ.Towards broadly protective polyvalent vaccines against hand, foot and mouth disease.Microbes Infect2015; 17:155–162.
  • SeeDM,TillesJG.Occurrence of coxsackievirus hepatitis in baby rabbits and protection by a formalin-inactivated polyvalent vaccine.Proc Soc Exp Biol Med1997; 216:52–56.
  • WuXY,ZhaoTQ,TianYet al.A bivalent VP1 gene vaccine against Coxsackie virus B1/B3.Natl Med J China2001; 81:480–484.
  • LiuZ,CarthyCM,CheungPet al.Structural and functional analysis of the 5′ untranslated region of coxsackievirus B3 RNA: In vivo translational and infectivity studies of full-length mutants.Virology1999; 265:206–217.
  • M’hadheb-GharbiMB,El HiarR,PaulousSet al.Role of GNRA motif mutations within stem-loop V of internal ribosome entry segment in coxsackievirus B3 molecular attenuation.J Mol Microbiol Biotechnol2008; 14:147–156.
  • LanJ,GaoZ,XiongHet al.Generation of protective immune responses against coxsackievirus B3 challenge by DNA prime-protein boost vaccination.Vaccine2011; 29:6894–6902.
  • Economic Daily. EV71 SHOUZUKOU YIMIAO KAISHI JIEZHONG, MEIJI JIAGE BU CHAO 218 YUAN. Chinese. Beijing: ED, 2016. Available athttp://baby.ce.cn/qt/201603/29/t20160329_3652260.shtml (accessed on 13 April 2016).
  • GanZK,JinH,LiJXet al.Disease burden of enterovirus 71 in rural central China: a community-based survey.Hum Vaccin Immunother2015; 11:2400–2405.
  • LeeBY,WateskaAR,BaileyRRet al.Forecasting the economic value of an enterovirus 71 (EV71) vaccine.Vaccine2010; 28:7731–7736.
  • LiL,YinH,AnZet al.Considerations for developing an immunization strategy with enterovirus 71 vaccine.Vaccine2015; 33:1107–1112.
  • KleinM,ChongP.Is a multivalent hand, foot, and mouth disease vaccine feasible?Hum Vaccin Immunother2015; 11:2688–2704.
  • LiuCC,ChowYH,ChongPet al.Prospect and challenges for the development of multivalent vaccines against hand, foot and mouth diseases.Vaccine2014; 32:6177–6182.
  • CaineEA,FuchsJ,DasSCet al.Efficacy of a trivalent hand, foot, and mouth disease vaccine against enterovirus 71 and coxsackieviruses A16 and A6 in mice.Viruses2015; 7:5919–5932.
  • LiuCC,GuoMS,WuSRet al.Immunological and biochemical characterizations of coxsackievirus A6 and A10 viral particles.Antiviral Res2016; 129:58–66.