Progress on the research and development of inactivated EV71 whole-virus vaccines

References

• Schmidt NJ, Lennette EH, Ho HH. An apparently new enterovirus isolated from patients with disease of the central nervous system. J Infect Dis 1974; 129:304 - 9; http://dx.doi.org/10.1093/infdis/129.3.304; PMID: 4361245
   PubMed Web of Science ®Google Scholar
• Solomon T, Lewthwaite P, Perera D, Cardosa MJ, McMinn P, Ooi MH. Virology, epidemiology, pathogenesis, and control of enterovirus 71. Lancet Infect Dis 2010; 10:778 - 90; http://dx.doi.org/10.1016/S1473-3099(10)70194-8; PMID: 20961813
   PubMed Web of Science ®Google Scholar
• Dong C, Wang J, Liu L, Zhao H, Shi H, Zhang Y, et al. Optimized development of a candidate strain of inactivated EV71 vaccine and analysis of its immunogenicity in rhesus monkeys. Hum Vaccin 2010; 6:1028 - 37; http://dx.doi.org/10.4161/hv.6.12.12982; PMID: 21150270
   PubMed Web of Science ®Google Scholar
• Liu L, Zhang Y, Wang J, Zhao H, Jiang L, Che Y, et al. Study of the integrated immune response induced by an inactivated EV71 vaccine. PLoS One 2013; 8:e54451; http://dx.doi.org/10.1371/journal.pone.0054451; PMID: 23372725
   PubMed Web of Science ®Google Scholar
• Dong C, Liu L, Zhao H, Wang J, Liao Y, Zhang X, et al. Immunoprotection elicited by an enterovirus type 71 experimental inactivated vaccine in mice and rhesus monkeys. Vaccine 2011; 29:6269 - 75; http://dx.doi.org/10.1016/j.vaccine.2011.06.044; PMID: 21722686
   PubMed Web of Science ®Google Scholar
• Li XL, Zhang ZY, Wang XX, Hao CS, Yang YJ, Li Y, et al. Immunogenicity and protective efficacy of the inactivated EV71 vaccine. Chinese Journal of Viral Diseases 2012; 6:415 - 8
   Google Scholar
• Bek EJ, Hussain KM, Phuektes P, Kok CC, Gao Q, Cai F, et al. Formalin-inactivated vaccine provokes cross-protective immunity in a mouse model of human enterovirus 71 infection. Vaccine 2011; 29:4829 - 38; http://dx.doi.org/10.1016/j.vaccine.2011.04.070; PMID: 21550375
   PubMed Web of Science ®Google Scholar
• Zhao HL, Wang JJ, Zhang Y, et al. Immunoprotection of Inactivated EV71 Vaccine Against Enterovirus in Neonatal Rhesus Monkey. SCIENTIA SINICA Vitae 2011; 41:439 - 48
   Google Scholar
• Chiu CH, Chu C, He CC, Lin TY. Protection of neonatal mice from lethal enterovirus 71 infection by maternal immunization with attenuated Salmonella enterica serovar Typhimurium expressing VP1 of enterovirus 71. Microbes Infect 2006; 8:1671 - 8; http://dx.doi.org/10.1016/j.micinf.2006.01.021; PMID: 16815726
   PubMed Web of Science ®Google Scholar
• Arita M, Nagata N, Iwata N, Ami Y, Suzaki Y, Mizuta K, et al. An attenuated strain of enterovirus 71 belonging to genotype a showed a broad spectrum of antigenicity with attenuated neurovirulence in cynomolgus monkeys. J Virol 2007; 81:9386 - 95; http://dx.doi.org/10.1128/JVI.02856-06; PMID: 17567701
   PubMed Web of Science ®Google Scholar
• Chung YC, Ho MS, Wu JC, Chen WJ, Huang JH, Chou ST, et al. Immunization with virus-like particles of enterovirus 71 elicits potent immune responses and protects mice against lethal challenge. Vaccine 2008; 26:1855 - 62; http://dx.doi.org/10.1016/j.vaccine.2008.01.058; PMID: 18329759
   PubMed Web of Science ®Google Scholar
• Wu CN, Lin YC, Fann C, Liao NS, Shih SR, Ho MS. Protection against lethal enterovirus 71 infection in newborn mice by passive immunization with subunit VP1 vaccines and inactivated virus. Vaccine 2001; 20:895 - 904; http://dx.doi.org/10.1016/S0264-410X(01)00385-1; PMID: 11738755
   PubMed Web of Science ®Google Scholar
• Chung CY, Chen CY, Lin SY, Chung YC, Chiu HY, Chi WK, et al. Enterovirus 71 virus-like particle vaccine: improved production conditions for enhanced yield. Vaccine 2010; 28:6951 - 7; http://dx.doi.org/10.1016/j.vaccine.2010.08.052; PMID: 20797455
   PubMed Web of Science ®Google Scholar
• Tung WS, Bakar SA, Sekawi Z, Rosli R. DNA vaccine constructs against enterovirus 71 elicit immune response in mice. Genet Vaccines Ther 2007; 5:6; http://dx.doi.org/10.1186/1479-0556-5-6; PMID: 17445254
   PubMedGoogle Scholar
• Foo DG, Alonso S, Chow VT, Poh CL. Passive protection against lethal enterovirus 71 infection in newborn mice by neutralizing antibodies elicited by a synthetic peptide. Microbes Infect 2007; 9:1299 - 306; http://dx.doi.org/10.1016/j.micinf.2007.06.002; PMID: 17890123
   PubMed Web of Science ®Google Scholar
• Liu JN, Wang W, Duo JY, Hao Y, Ma CM, Li WB, et al. Combined peptides of human enterovirus 71 protect against virus infection in mice. Vaccine 2010; 28:7444 - 51; http://dx.doi.org/10.1016/j.vaccine.2010.08.080; PMID: 20831911
   PubMed Web of Science ®Google Scholar
• Chong P, Hsieh SY, Liu CC, Chou AH, Chang JY, Wu SC, et al. Production of EV71 vaccine candidates. Hum Vaccin Immunother 2012; 8; http://dx.doi.org/10.4161/hv.21739; PMID: 22992566
   PubMed Web of Science ®Google Scholar
• Li YP, Liang ZL, Gao Q, Huang LR, Mao QY, Wen SQ, et al. Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: a randomized, placebo-controlled, double-blind, Phase I clinical trial. Vaccine 2012; 30:3295 - 303; http://dx.doi.org/10.1016/j.vaccine.2012.03.010; PMID: 22426327
   PubMed Web of Science ®Google Scholar
• Liang Z, Mao Q, Gao Q, Li X, Dong C, Yu X, et al. Establishing China’s national standards of antigen content and neutralizing antibody responses for evaluation of enterovirus 71 (EV71) vaccines. Vaccine 2011; 29:9668 - 74; http://dx.doi.org/10.1016/j.vaccine.2011.10.018; PMID: 22015395
   PubMed Web of Science ®Google Scholar
• Liu CC, Chang HW, Yang G, Chiang JR, Chow YH, Sai IH, et al. Development of a quantitative enzyme linked immunosorbent assay for monitoring the Enterovirus 71 vaccine manufacturing process. J Virol Methods 2011; 176:60 - 8; http://dx.doi.org/10.1016/j.jviromet.2011.06.001; PMID: 21704080
   PubMed Web of Science ®Google Scholar
• Liu CC, Guo MS, Lin FH, Hsiao KN, Chang KH, Chou AH, et al. Purification and characterization of enterovirus 71 viral particles produced from vero cells grown in a serum-free microcarrier bioreactor system. PLoS One 2011; 6:e20005; http://dx.doi.org/10.1371/journal.pone.0020005; PMID: 21603631
   PubMed Web of Science ®Google Scholar
• Long RX, Xie ZP, Yang R, Li H, Bai HZ, Dong CH, et al. Development and Application of BA-ELISA Method for EV71 Antigen. Chinese Journal of Biological 2009; 12:1230 - 2
   Google Scholar
• Jia H, Cai F, Gao Q, Zhang JS, Jing SR. Development of A Quantitative ELISA Method for EV71 Antigen. Chinese Journal of Biologicals 2010; 23:87 - 90
   Google Scholar
• Meng FY, Li JX, Li XL, Chu K, Zhang YT, Ji H, et al. Tolerability and immunogenicity of an inactivated enterovirus 71 vaccine in Chinese healthy adults and children: an open label, phase 1 clinical trial. Hum Vaccin Immunother 2012; 8:668 - 74; http://dx.doi.org/10.4161/hv.19521; PMID: 22634437
   PubMed Web of Science ®Google Scholar
• A Protected Study of Inactivated EV71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants and Children. Mar 10, 2013 2013. http://www.deepdyve.com/lp/clinical-trials/a-protected-study-of-inactivated-ev71-vaccine-human-diploid-cell-kmb-679kOYq0nc/1.
   Google Scholar
• Positive topline results from Phase III trial of Enterovirus 71 vaccine (Sinovac Biotech) against Hand, Foot and Mouth Disease. 2013. http://www.epgonline.org/news/2013/Mar/Positive-topline-results-fromPhase.cfm.
   Google Scholar
• Liang Y, Zhao HL, Liu LD, Liao Y, Dong CH, Na RX, et al. Large scale preparation of enterovirus type 71 inactivated vaccine in human diploid cells and its immunogenic study. Chinese Journal of Viral Diseases 2012; 2:409 - 14
   Google Scholar
• Liu L, Zhao H, Zhang Y, Wang J, Che Y, Dong C, et al. Neonatal rhesus monkey is a potential animal model for studying pathogenesis of EV71 infection. Virology 2011; 412:91 - 100; http://dx.doi.org/10.1016/j.virol.2010.12.058; PMID: 21262515
   PubMed Web of Science ®Google Scholar
• Chen H, Zhang Y, Yang E, Liu L, Che Y, Wang J, et al. The effect of enterovirus 71 immunization on neuropathogenesis and protein expression profiles in the thalamus of infected rhesus neonates. Virology 2012; 432:417 - 26; http://dx.doi.org/10.1016/j.virol.2012.06.026; PMID: 22819834
   PubMed Web of Science ®Google Scholar
• Liang Y, Zhou X, Yang E, Pu J, Che Y, Wang J, et al. Analysis of the Th1/Th2 reaction in the immune response induced by EV71 inactivated vaccine in neonatal rhesus monkeys. J Clin Immunol 2012; 32:1048 - 58; http://dx.doi.org/10.1007/s10875-012-9690-3; PMID: 22585051
   PubMed Web of Science ®Google Scholar
• Mao Q, Li N, Yu X, Yao X, Li F, Lu F, et al. Antigenicity, animal protective effect and genetic characteristics of candidate vaccine strains of enterovirus 71. Arch Virol 2012; 157:37 - 41; http://dx.doi.org/10.1007/s00705-011-1136-3; PMID: 21984267
   PubMed Web of Science ®Google Scholar
• Zhu FC, Wang JZ, Li XL, Liang ZL, Ge HM, Meng FY, et al. Reactogenicity and immunogenicity of an enterovirus 71 vaccine in Chinese healthy children and infants. Pediatr Infect Dis J 2012; 31:1158 - 65; http://dx.doi.org/10.1097/INF.0b013e31826eba74; PMID: 22926209
   PubMed Web of Science ®Google Scholar
• Zhu FC, Liang ZL, Li XL, Ge HM, Meng FY, Mao QY, et 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. Lancet 2013; PMID: 23352749
   PubMed Web of Science ®Google Scholar
• http://wb.yunnan.cn/html/2013/ducheng_0312/64349.html
   Google Scholar
• EV71 Inactivated Vaccine Which Independently Researched and Developed by China has Achieved Important Progress – Phase III Clinical Research Demonstrated Good Efficacy and Safety. 2013. http://en.cnbg.com.cn/html/news/2013/0326/768.html
   Google Scholar
• Chang JY, Chang CP, Tsai HH, Lee CD, Lian WC, Ih-Jen-Su, et al. Selection and characterization of vaccine strain for Enterovirus 71 vaccine development. Vaccine 2012; 30:703 - 11; http://dx.doi.org/10.1016/j.vaccine.2011.11.087; PMID: 22142585
   PubMed Web of Science ®Google Scholar
• Lin YC, Wu CN, Shih SR, Ho MS. Characterization of a Vero cell-adapted virulent strain of enterovirus 71 suitable for use as a vaccine candidate. Vaccine 2002; 20:2485 - 93; http://dx.doi.org/10.1016/S0264-410X(02)00182-2; PMID: 12057603
   PubMed Web of Science ®Google Scholar
• Chou AH, Liu CC, Chang JY, Lien SP, Guo MS, Tasi HP, et al. Immunological evaluation and comparison of different EV71 vaccine candidates. Clin Dev Immunol 2012; 2012:831282; http://dx.doi.org/10.1155/2012/831282; PMID: 23008736
   PubMed Web of Science ®Google Scholar
• Chou AH, Liu CC, Chang CP, Guo MS, Hsieh SY, Yang WH, et al. Pilot scale production of highly efficacious and stable enterovirus 71 vaccine candidates. PLoS One 2012; 7:e34834; http://dx.doi.org/10.1371/journal.pone.0034834; PMID: 22529942
   PubMed Web of Science ®Google Scholar
• Wu SC, Liu CC, Lian WC. Optimization of microcarrier cell culture process for the inactivated enterovirus type 71 vaccine development. Vaccine 2004; 22:3858 - 64; http://dx.doi.org/10.1016/j.vaccine.2004.05.037; PMID: 15364432
   PubMed Web of Science ®Google Scholar
• Liu CC, Lian WC, Butler M, Wu SC. High immunogenic enterovirus 71 strain and its production using serum-free microcarrier Vero cell culture. Vaccine 2007; 25:19 - 24; http://dx.doi.org/10.1016/j.vaccine.2006.06.083; PMID: 16919374
   PubMed Web of Science ®Google Scholar
• Cheng A, Fung CP, Liu CC, Lin YT, Tsai HY, Chang SC, et al. A Phase I, randomized, open-label study to evaluate the safety and immunogenicity of an enterovirus 71 vaccine. Vaccine 2013; 31:2471 - 6; http://dx.doi.org/10.1016/j.vaccine.2013.03.015; PMID: 23541623
   PubMed Web of Science ®Google Scholar
• Safety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus. http://prsinfo.clinicaltrial.gov/ct2/show/nct01376479?term=inviragen+%28singapore%29+pte+ltd.&rank=1 2013.
   Google Scholar
• Requirements for the use of animal cells as in vitro substrates for the production of biologicals. WHO Expert Comminittee on Biological Standardization Forty-seventh Report. Geneva,World Health Organization; 1998.
   Google Scholar
• Requirements for continuous cell lines used for biological production. WHO Expert Commmitte on Biological Standardiztion Thirty-sixth Report Geneva, World Health Organization: (WHO Technical Report Series, No. 745,Annex 3). 1987.
   Google Scholar
• Cell Lines Derived from Human Tumors for Vaccine Manufacture. Vaccines and Related Biological Products Advisory Committee Meeting 2012; 2012.
   Google Scholar
• Safety of biological products prepared from mammalian cell culture. DNA. 1st ed. Basel: S Karger; 1998.
   Google Scholar
• Theresa M. Finn WE. Vaccine additives and manufacturing residuals in the United States: licensed vaccines. 6th ed. Edinburgh: Elsevier/Saunders; 2013.
   Google Scholar
• Cao S, Dong G, Tang J, Li J, Liu J, Shi L, et al. Development of a Vero cell DNA reference standard for residual DNA measurement in China. Hum Vaccin Immunother 2013; 9; http://dx.doi.org/10.4161/hv.22699; PMID: 23291952
   PubMed Web of Science ®Google Scholar
• Mao QY, He P, Yu X, Li N, Hao CS, Gao Q, et al. Laboratory Evaluation of Method for Determination of Neutralizing Antibodyagainst Human Enterovirus 71. Chin J Biologicals 2010; 8:99 - 102
   Google Scholar
• Mao Q, Dong C, Li X, Gao Q, Guo Z, Yao X, et al. Comparative analysis of the immunogenicity and protective effects of inactivated EV71 vaccines in mice. PLoS One 2012; 7:e46043; http://dx.doi.org/10.1371/journal.pone.0046043; PMID: 23029378
   PubMed Web of Science ®Google Scholar
• Wu X, Mao QY, Yao X, Chen P, Chen XM, Shao J, et al.Development and Evaluation of a Pseudovirus-Luciferase Assay for Rapid and Quantitative Detection of Neutralizing Antibodies against Enterovirus 71. PLoS ONE 2013; 8: e64116.
   Google Scholar
• Tan X, Huang X, Zhu S, Chen H, Yu Q, Wang H, et al. The persistent circulation of enterovirus 71 in People’s Republic of China: causing emerging nationwide epidemics since 2008. PLoS One 2011; 6:e25662; http://dx.doi.org/10.1371/journal.pone.0025662; PMID: 21980521
   PubMed Web of Science ®Google Scholar
• Zhang D, Lu J, Lu J. Enterovirus 71 vaccine: close but still far. Int J Infect Dis 2010; 14:e739 - 43; http://dx.doi.org/10.1016/j.ijid.2009.12.002; PMID: 20400350
   PubMed Web of Science ®Google Scholar
• Lee MS, Tseng FC, Wang JR, Chi CY, Chong P, Su IJ. Challenges to licensure of enterovirus 71 vaccines. PLoS Negl Trop Dis 2012; 6:e1737; http://dx.doi.org/10.1371/journal.pntd.0001737; PMID: 22953003
   PubMed Web of Science ®Google Scholar
• Xu J, Qian Y, Wang S, Serrano JM, Li W, Huang Z, et al. EV71: an emerging infectious disease vaccine target in the Far East?. Vaccine 2010; 28:3516 - 21; http://dx.doi.org/10.1016/j.vaccine.2010.03.003; PMID: 20304038
   PubMed Web of Science ®Google Scholar