914
Views
11
CrossRef citations to date
0
Altmetric
Research Papers

Comprehensive safety assessment of a human inactivated diploid enterovirus 71 vaccine based on a phase III clinical trial

, , , , &
Pages 922-930 | Received 17 Jun 2015, Accepted 29 Oct 2015, Published online: 16 Mar 2016

References

  • Xiao G, Hu Y, Yu S, Ma J. Epidemiology of hand, foot and mouth disease in children aged 5 years in China, 2008–2011. Dis Surveill 2012; 27:932-6.
  • Ooi MH, Wong SC, Lewthwaite P, Cardosa MJ, Solomon T. Clinical features, diagnosis, and management of enterovirus 71. Lancet Neurol 2010; 9:1097-105; PMID:20965438; http://dx.doi.org/10.1016/S1474-4422(10)70209-X
  • Lum LC, Wong KT, Lam SK, Chua KB, Goh AY. Neurogenic pulmonary oedema and enterovirus 71 encephalomyelitis. Lancet 1998; 352:1391; PMID:9802304; http://dx.doi.org/10.1016/S0140-6736(05)60789-1
  • Chang LY, Lin TY, Hsu KH, Huang YC, Lin KL, Hsueh C, Shih SR, Ning HC, Hwang MS, Wang HS, et al. Clinical features and risk factors of pulmonary oedema after enterovirus-71-related hand, foot, and mouth disease. Lancet 1999; 354:1682-6; PMID:10568570; http://dx.doi.org/10.1016/S0140-6736(99)04434-7
  • Sun S, Jiang L, Liang Z, Mao Q, Su W, Zhang H, Li X, Jin J, Xu L, Zhao D, et al. Evaluation of monovalent and bivalent vaccines against lethal Enterovirus 71 and Coxsackievirus A16 infection in newborn mice. Hum Vaccin Immunother 2014; 10:2885-95; PMID:25483672; http://dx.doi.org/10.4161/hv.29823
  • De W, Changwen K, Wei L, Monagin C, Jin Y, Cong M, Hanri Z, Jun S. A large outbreak of hand, foot, and mouth disease caused by EV71 and CAV16 in Guangdong, China, 2009. Arch Virol 2011; 156:945-53; PMID:21305327; http://dx.doi.org/10.1007/s00705-011-0929-8
  • Ho M. Enterovirus 71: the virus, its infections and outbreaks. J Microbiol Immunol Infect 2000; 33:205-16; PMID:11269363
  • WHO. Report on the Hand, Foot and Mouth Disease Outbreak in Fuyang City, Anhui Province and the Prevention and Control in China. 2008:1-25.
  • Li YP, Liang ZL, Gao Q, Huang LR, Mao QY, Wen SQ, Liu Y, Yin WD, Li RC, Wang JZ. 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; PMID:22426327; http://dx.doi.org/10.1016/j.vaccine.2012.03.010
  • Chong P, Liu CC, Chow YH, Chou AH, Klein M. Review of enterovirus 71 vaccines. Clin Infect Dis 2015; 60:797-803; PMID:25352588; http://dx.doi.org/10.1093/cid/ciu852
  • McMinn PC. An overview of the evolution of enterovirus 71 and its clinical and public health significance. FEMS Microbiol Rev 2002; 26:91-107; PMID:12007645; http://dx.doi.org/10.1111/j.1574-6976.2002.tb00601.x
  • Weng KF, Chen LL, Huang PN, Shih SR. Neural pathogenesis of enterovirus 71 infection. Microbes Infect 2010; 12:505-10; PMID:20348010; http://dx.doi.org/10.1016/j.micinf.2010.03.006
  • Zhu FC, Liang ZL, Li XL, Ge HM, Meng FY, Mao QY, Zhang YT, Hu YM, Zhang ZY, Li JX, 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; 381:1037-45; PMID:23352749; http://dx.doi.org/10.1016/S0140-6736(12)61764-4
  • Tan X, Huang X, Zhu S, Chen H, Yu Q, Wang H, Huo X, Zhou J, Wu Y, Yan D, 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; PMID:21980521; http://dx.doi.org/10.1371/journal.pone.0025662
  • Zhang Y, Tan X, Cui A, Mao N, Xu S, Zhu Z, Zhou J, Shi J, Zhao Y, Wang X, et al. Complete genome analysis of the C4 subgenotype strains of enterovirus 71: predominant recombination C4 viruses persistently circulating in China for 14 years. PLoS One 2013; 8:e56341; PMID:23441179; http://dx.doi.org/10.1371/journal.pone.0056341
  • Sun LM, Zheng HY, Zheng HZ, Guo X, He JF, Guan DW, Kang M, Liu Z, Ke CW, Li JS, et al. An enterovirus 71 epidemic in Guangdong Province of China, 2008: epidemiological, clinical, and virogenic manifestations. Jpn J Infect Dis 2011; 64:13-8; PMID:21266750
  • Yi L, Lu J, Kung HF, He ML. The virology and developments toward control of human enterovirus 71. Crit Rev Microbiol 2011; 37:313-27; PMID:21651436; http://dx.doi.org/10.3109/1040841X.2011.580723
  • Kung YA, Hung CT, Liu YC, Shih SR. Update on the development of enterovirus 71 vaccines. Expert Opin Biol Ther 2014; 14:1455-64; PMID:24989170; http://dx.doi.org/10.1517/14712598.2014.935330
  • Zhu FC, Meng FY, Li JX, Li XL, Mao QY, Tao H, Zhang YT, Yao X, Chu K, Chen QH, et 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. Lancet 2013; 381:2024-32; PMID:23726161; http://dx.doi.org/10.1016/S0140-6736(13)61049-1
  • Li YP, Liang ZL, Xia JL, Wu JY, Wang L, Song LF, Mao QY, Wen SQ, Huang RG, Hu YS, et al. Immunogenicity, safety, and immune persistence of a novel inactivated human enterovirus 71 vaccine: a phase II, Randomized, double-blind, placebo-controlled Trial. J Infect Dis 2014; 209:46-55; PMID:23922377; http://dx.doi.org/10.1093/infdis/jit429
  • Liang Z, Wang J. EV71 vaccine, an invaluable gift for children. Clin Transl Immunology 2014; 3:e28; PMID:25505956; http://dx.doi.org/10.1038/cti.2014.24
  • Liang ZL, Mao QY, Wang YP, Zhu FC, Li JX, Yao X, Gao F, Wu X, Xu M, Wang JZ. Progress on the research and development of inactivated EV71 whole-virus vaccines. Hum Vaccin Immunother 2013; 9:1701-5; PMID:23744508; http://dx.doi.org/10.4161/hv.24949
  • Jee YM, Cheon DS, Kim K, Cho JH, Chung YS, Lee J, Lee SH, Park KS, Lee JH, Kim EC, et al. Genetic analysis of the VP1 region of human enterovirus 71 strains isolated in Korea during 2000. Arch Virol 2003; 148:1735-46; PMID:14505086; http://dx.doi.org/10.1007/s00705-003-0133-6
  • Hwa SH, Lee YA, Brewoo JN, Partidos CD, Osorio JE, Santangelo JD. Preclinical evaluation of the immunogenicity and safety of an inactivated enterovirus 71 candidate vaccine. PLoS Negl Trop Dis 2013; 7:e2538; PMID:24244774; http://dx.doi.org/10.1371/journal.pntd.0002538
  • Cheng A, Fung CP, Liu CC, Lin YT, Tsai HY, Chang SC, Chou AH, Chang JY, Jiang RH, Hsieh YC, 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; PMID:23541623; http://dx.doi.org/10.1016/j.vaccine.2013.03.015
  • Liu CC, Chow YH, Chong P, Klein M. Prospect and challenges for the development of multivalent vaccines against hand, foot and mouth diseases. Vaccine 2014; 32:6177-82; PMID:25218294; http://dx.doi.org/10.1016/j.vaccine.2014.08.064
  • Yun KW, Lee HJ, Kang JH, Eun BW, Kim YJ, Kim KH, Kim NH, Hong YJ, Kim DH, Kim HM, et al. Safety and immunogenicity of a freeze-dried, Vero cell culture-derived, inactivated Japanese encephalitis vaccine (KD-287, ENCEVAC(R)) versus a mouse brain-derived inactivated Japanese encephalitis vaccine in children: a phase III, multicenter, double-blinded, randomized trial. BMC Infect Dis 2015; 15:7; PMID:25567119; http://dx.doi.org/10.1186/s12879-014-0744-4
  • Carmona Martinez A, Salamanca de la Cueva I, Boutet P, Vanden Abeele C, Smolenov I, Devaster JM. A phase 1, open-label safety and immunogenicity study of an AS03-adjuvanted trivalent inactivated influenza vaccine in children aged 6 to 35 months. Hum Vaccin Immunother 2014; 10:1959-68; PMID:25424805; http://dx.doi.org/10.4161/hv.28743
  • Chou AH, Liu CC, Chang JY, Jiang R, Hsieh YC, Tsao A, Wu CL, Huang JL, Fung CP, Hsieh SM, et al. Formalin-inactivated EV71 vaccine candidate induced cross-neutralizing antibody against subgenotypes B1, B4, B5 and C4A in adult volunteers. PLoS One 2013; 8:e79783; PMID:24278177; http://dx.doi.org/10.1371/journal.pone.0079783
  • Li JX, Mao QY, Liang ZL, Ji H, Zhu FC. Development of enterovirus 71 vaccines: from the lab bench to Phase III clinical trials. Expert Rev Vaccines 2014; 13:609-18; PMID:24621093; http://dx.doi.org/10.1586/14760584.2014.897617
  • Chen YJ, Meng FY, Mao Q, Li JX, Wang H, Liang ZL, Zhang YT, Gao F, Chen QH, Hu Y, et al. Clinical evaluation for batch consistency of an inactivated enterovirus 71 vaccine in a large-scale phase 3 clinical trial. Hum Vaccin Immunother 2014; 10:1366-72; PMID:24633366; http://dx.doi.org/10.4161/hv.28397
  • Li R, Liu L, Mo Z, Wang X, Xia J, Liang Z, Zhang Y, Li Y, Mao Q, Wang J, et al. An inactivated enterovirus 71 vaccine in healthy children. N Engl J Med 2014; 370:829-37; PMID:24571755; http://dx.doi.org/10.1056/NEJMoa1303224
  • Zhu F, Xu W, Xia J, Liang Z, Liu Y, Zhang X, Tan X, Wang L, Mao Q, Wu J, et al. Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China. N Engl J Med 2014; 370:818-28; PMID:24571754; http://dx.doi.org/10.1056/NEJMoa1304923
  • Liu L, Zhang Y, Wang J, Zhao H, Jiang L, Che Y, Shi H, Li R, Mo Z, Huang T, et al. Study of the integrated immune response induced by an inactivated EV71 vaccine. PLoS One 2013; 8:e54451; PMID:23372725; http://dx.doi.org/10.1371/journal.pone.0054451
  • Ma SH, Liu JS, Wang JJ, Shi HJ, Yang HJ, Chen JY, Liu LD, Li QH. Genetic analysis of the VP1 region of human enterovirus 71 strains isolated in Fuyang, China, during 2008. Virologica Sinica 2009; 24:162-70; http://dx.doi.org/10.1007/s12250-009-3033-4
  • Belshe RB, Frey SE, Graham IL, Anderson EL, Jackson LA, Spearman P, Edupuganti S, Mulligan MJ, Rouphael N, Winokur P, et al. Immunogenicity of avian influenza A/Anhui/01/2005(H5N1) vaccine with MF59 adjuvant: a randomized clinical trial. JAMA 2014; 312:1420-8; PMID:25291578; http://dx.doi.org/10.1001/jama.2014.12609
  • Wysocki J, Brzostek J, Szymanski H, Tetiurka B, Toporowska-Kowalska E, Wasowska-Krolikowska K, Sarkozy DA, Giardina PC, Gruber WC, Emini EA, et al. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine administered to older infants and children naive to pneumococcal vaccination. Vaccine 2015; 33:1719-25; PMID:25698485; http://dx.doi.org/10.1016/j.vaccine.2015.02.005
  • Nolan T, Richmond PC, McVernon J, Skeljo MV, Hartel GF, Bennet J, Basser RL. Safety and immunogenicity of an inactivated thimerosal-free influenza vaccine in infants and children. Influenza Other Respir Viruses 2009; 3:315-25; PMID:19903213; http://dx.doi.org/10.1111/j.1750-2659.2009.00108.x
  • Lambert SB, Chuk LM, Nissen MD, Nolan TM, McVernon J, Booy R, Heron L, Richmond PC, Walls T, Marshall HS, et al. Safety and tolerability of a 2009 trivalent inactivated split-virion influenza vaccine in infants, children and adolescents. Influenza Other Respir Viruses 2013; 7:676-85; PMID:23551933; http://dx.doi.org/10.1111/irv.12107
  • Shenyu W, Jingxin L, Zhenglun L, Xiuling L, Qunying M, Fanyue M, Hua W, Yuntao Z, Fan G, Qinghua C, et al. A booster dose of an inactivated enterovirus 71 vaccine in chinese young children: a randomized, double-blind, placebo-controlled clinical trial. J Infect Dis 2014; 210:1073-82; PMID:24625805; http://dx.doi.org/10.1093/infdis/jiu113
  • Hu YM, Wang X, Wang JZ, Wang L, Zhang YJ, Chang L, Liang ZL, Xia JL, Dai QG, Hu YL, et al. Immunogenicity, safety, and lot consistency of a novel inactivated enterovirus 71 vaccine in Chinese children aged 6 to 59 months. Clin Vaccine Immunol 2013; 20:1805-11; PMID:24108780; http://dx.doi.org/10.1128/CVI.00491-13
  • Li L, Yin H, An Z, Feng Z. Considerations for developing an immunization strategy with enterovirus 71 vaccine. Vaccine 2015; 33:1107-12; PMID:25444807; http://dx.doi.org/10.1016/j.vaccine.2014.10.081

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.