The development of a recombinant hepatitis E vaccine HEV 239

References

• Kamar N, Bendall R, Legrand-Abravanel F, Xia NS, Ijaz S, Izopet J, Dalton HR. Hepatitis E. Lancet 2012; 379(9835):2477-88; PMID:22549046; http://dx.doi.org/10.1016/S0140-6736(11)61849-7
   PubMed Web of Science ®Google Scholar
• Krain LJ, Nelson KE, Labrique AB. Host immune status and response to hepatitis E virus infection. Clin Microbiol Rev 2014; 27(1):139-65; PMID:24396140; http://dx.doi.org/10.1128/CMR.00062-13
   PubMed Web of Science ®Google Scholar
• Purcell RH, Emerson SU. Hepatitis E: an emerging awareness of an old disease. J Hepatol 2008; 48(3):494-503; PMID:18192058; http://dx.doi.org/10.1016/j.jhep.2007.12.008
   PubMed Web of Science ®Google Scholar
• Huang FF, Sun ZF, Emerson SU, Purcell RH, Shivaprasad HL, Pierson FW, Toth TE, Meng XJ. Determination and analysis of the complete genomic sequence of avian hepatitis E virus (avian HEV) and attempts to infect rhesus monkeys with avian HEV. J Gen Virol 2004; 85(Pt 6):1609-18; PMID:15166445; http://dx.doi.org/10.1099/vir.0.79841-0
   PubMed Web of Science ®Google Scholar
• Shrestha MP, Scott RM, Joshi DM, Mammen MP, Jr., Thapa GB, Thapa N, Myint KS, Fourneau M, Kuschner RA, Shrestha SK, et al. Safety and efficacy of a recombinant hepatitis E vaccine. N Engl J Med 2007; 356(9):895-903; PMID:17329696; http://dx.doi.org/10.1056/NEJMoa061847
   PubMed Web of Science ®Google Scholar
• Zhang J, Liu CB, Li RC, Li YM, Zheng YJ, Li YP, Luo D, Pan BB, Nong Y, Ge SX, et al. Randomized-controlled phase II clinical trial of a bacterially expressed recombinant hepatitis E vaccine. Vaccine 2009; 27(12):1869-74; PMID:19168109; http://dx.doi.org/10.1016/j.vaccine.2008.12.061
   PubMed Web of Science ®Google Scholar
• Zhu FC, Zhang J, Zhang XF, Zhou C, Wang ZZ, Huang SJ, Wang H, Yang CL, Jiang HM, Cai JP, et al. Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial. Lancet 2010; 376(9744):895-902; PMID:20728932; http://dx.doi.org/10.1016/S0140-6736(10)61030-6
   PubMed Web of Science ®Google Scholar
• Wu T, Li SW, Zhang J, Ng MH, Xia NS, Zhao Q. Hepatitis E vaccine development: a 14 year odyssey. Hum Vaccin Immunother 2012; 8(6):823-7; PMID:22699438; http://dx.doi.org/10.4161/hv.20042
   PubMed Web of Science ®Google Scholar
• Xing L, Li TC, Mayazaki N, Simon MN, Wall JS, Moore M, Wang CY, Takeda N, Wakita T, Miyamura T, et al. Structure of hepatitis E virion-sized particle reveals an RNA-dependent viral assembly pathway. J Biol Chem 2010; 285(43):33175-83; PMID:20720013; http://dx.doi.org/10.1074/jbc.M110.106336
   PubMedGoogle Scholar
• Li TC, Yoshimatsu K, Yasuda SP, Arikawa J, Koma T, Kataoka M, Ami Y, Suzaki Y, Mai le TQ, Hoa NT, et al. Characterization of self-assembled virus-like particles of rat hepatitis E virus generated by recombinant baculoviruses. J Gen Virol 2011; 92(Pt 12):2830-7; PMID:21865442; http://dx.doi.org/10.1099/vir.0.034835-0
   PubMedGoogle Scholar
• Guu TS, Liu Z, Ye Q, Mata DA, Li K, Yin C, Zhang J, Tao YJ. Structure of the hepatitis E virus-like particle suggests mechanisms for virus assembly and receptor binding. Proc Natl Acad Sci U S A 2009; 106(31):12992-7; PMID:19622744; http://dx.doi.org/10.1073/pnas.0904848106
   PubMedGoogle Scholar
• Yamashita T, Mori Y, Miyazaki N, Cheng RH, Yoshimura M, Unno H, Shima R, Moriishi K, Tsukihara T, Li TC, et al. Biological and immunological characteristics of hepatitis E virus-like particles based on the crystal structure. Proc Natl Acad Sci U S A 2009; 106(31):12986-91; PMID:19620712; http://dx.doi.org/10.1073/pnas.0903699106
   PubMedGoogle Scholar
• Li S, Tang X, Seetharaman J, Yang C, Gu Y, Zhang J, Du H, Shih JW, Hew CL, Sivaraman J, et al. Dimerization of hepatitis E virus capsid protein E2s domain is essential for virus-host interaction. PLoS Pathog 2009; 5(8):e1000537; PMID:19662165; http://dx.doi.org/10.1371/journal.ppat.1000537
   PubMed Web of Science ®Google Scholar
• Tang X, Yang C, Gu Y, Song C, Zhang X, Wang Y, Zhang J, Hew CL, Li S, Xia N, et al. Structural basis for the neutralization and genotype specificity of hepatitis E virus. Proc Natl Acad Sci U S A 2011; 108(25):10266-71; PMID:21642534; http://dx.doi.org/10.1073/pnas.1101309108
   PubMed Web of Science ®Google Scholar
• Zhang J, Gu Y, Ge SX, Li SW, He ZQ, Huang GY, Zhuang H, Ng MH, Xia NS. Analysis of hepatitis E virus neutralization sites using monoclonal antibodies directed against a virus capsid protein. Vaccine 2005; 23(22):2881-92; PMID:15780737; http://dx.doi.org/10.1016/j.vaccine.2004.11.065
   PubMed Web of Science ®Google Scholar
• Li SW, Zhang J, Li YM, Ou SH, Huang GY, He ZQ, Ge SX, Xian YL, Pang SQ, Ng MH, et al. A bacterially expressed particulate hepatitis E vaccine: antigenicity, immunogenicity and protectivity on primates. Vaccine 2005; 23(22):2893-901; PMID:15780738; http://dx.doi.org/10.1016/j.vaccine.2004.11.064
   PubMed Web of Science ®Google Scholar
• Zhao Q, Li S, Yu H, Xia N, Modis Y. Virus-like particle-based human vaccines: quality assessment based on structural and functional properties. Trends Biotechnol 2013; 31(11):654-63; PMID:24125746; http://dx.doi.org/10.1016/j.tibtech.2013.09.002
   PubMed Web of Science ®Google Scholar
• Grgacic EV, Anderson DA. Virus-like particles: passport to immune recognition. Methods (San Diego, Calif) 2006; 40(1):60-5; PMID:16997714; http://dx.doi.org/10.1016/j.ymeth.2006.07.018
   PubMed Web of Science ®Google Scholar
• Yang C, Pan H, Wei M, Zhang X, Wang N, Gu Y, Du H, Zhang J, Li S, Xia N. Hepatitis E virus capsid protein assembles in 4M urea in the presence of salts. Protein Sci 2013; 22(3):314-26; PMID:23281113; http://dx.doi.org/10.1002/pro.2213
   PubMed Web of Science ®Google Scholar
• Zhang X, Wei M, Pan H, Lin Z, Wang K, Weng Z, Zhu Y, Xin L, Zhang J, Li S, et al. Robust manufacturing and comprehensive characterization of recombinant hepatitis E virus-like particles in Hecolin((R)). Vaccine 2014; 32(32):4039-50; PMID:24892250; http://dx.doi.org/10.1016/j.vaccine.2014.05.064
   PubMed Web of Science ®Google Scholar
• Wu T, Wu XL, Ou SH, Lin CX, Cheng T, Li SW, Ng MH, Zhang J, Xia NS. Difference of T cell and B cell activation in two homologous proteins with similar antigenicity but great distinct immunogenicity. Mol Immunol 2007; 44(12):3261-6; PMID:17408743; http://dx.doi.org/10.1016/j.molimm.2007.01.002
   PubMedGoogle Scholar
• Zhang J, Shih JW, Wu T, Li SW, Xia NS. Development of the hepatitis E vaccine: from bench to field. Semin Liver Dis 2013; 33(1):79-88; PMID:23564392; http://dx.doi.org/10.1055/s-0033-1338116
   PubMed Web of Science ®Google Scholar
• Zhao Q, Zhang J, Wu T, Li SW, Ng MH, Xia NS, Shih JW. Antigenic determinants of hepatitis E virus and vaccine-induced immunogenicity and efficacy. J Gastroenterol 2013; 48(2):159-68; PMID:23149436; http://dx.doi.org/10.1007/s00535-012-0701-1
   PubMed Web of Science ®Google Scholar
• Deschuyteneer M, Elouahabi A, Plainchamp D, Plisnier M, Soete D, Corazza Y, Lockman L, Giannini S, Deschamps M. Molecular and structural characterization of the L1 virus-like particles that are used as vaccine antigens in Cervarix, the AS04-adjuvanted HPV-16 and -18 cervical cancer vaccine. Hum Vaccin 2010; 6(5):407-19; PMID:20953154; http://dx.doi.org/10.4161/hv.6.5.11023
   PubMed Web of Science ®Google Scholar
• Mulder AM, Carragher B, Towne V, Meng Y, Wang Y, Dieter L, Potter CS, Washabaugh MW, Sitrin RD, Zhao Q. Toolbox for non-intrusive structural and functional analysis of recombinant VLP based vaccines: a case study with hepatitis B vaccine. PloS one 2012; 7(4):e33235; PMID:22493667; http://dx.doi.org/10.1371/journal.pone.0033235
   PubMedGoogle Scholar
• Wei M, Zhang X, Yu H, Tang ZM, Wang K, Li Z, Zheng Z, Li S, Zhang J, Xia N, et al. Bacteria expressed hepatitis E virus capsid proteins maintain virion-like epitopes. Vaccine 2014; 32(24):2859-65; PMID:24662711; http://dx.doi.org/10.1016/j.vaccine.2014.02.025
   PubMed Web of Science ®Google Scholar
• Zhang Y, Li M, Yang F, Li Y, Zheng Z, Zhang X, Lin Q, Wang Y, Li SW, Xia NS, et al. Comparable quality attributes of hepatitis E vaccine antigen with and without adjuvant adsorption-dissolution treatment, Hum Vaccin Immunothare, 2015, In Press.
   Google Scholar
• Towne V, Zhao Q, Brown M, Finnefrock AC. Pairwise antibody footprinting using surface plasmon resonance technology to characterize human papillomavirus type 16 virus-like particles with direct anti-HPV antibody immobilization. J Immunol Methods 2013; 388(1-2):1-7; PMID:23159495; http://dx.doi.org/10.1016/j.jim.2012.11.005
   PubMedGoogle Scholar
• Zhao Q, Potter CS, Carragher B, Lander G, Sworen J, Towne V, Abraham D, Duncan P, Washabaugh MW, Sitrin RD. Characterization of virus-like particles in GARDASIL(R) by cryo transmission electron microscopy. Hum Vaccin Immunother 2014; 10(3):734-9; PMID:24299977; http://dx.doi.org/10.4161/hv.27316
   PubMed Web of Science ®Google Scholar
• Shank-Retzlaff M, Wang F, Morley T, Anderson C, Hamm M, Brown M, Rowland K, Pancari G, Zorman J, Lowe R, et al. Correlation between mouse potency and in vitro relative potency for human papillomavirus Type 16 virus-like particles and Gardasil vaccine samples. Hum Vaccin 2005; 1(5):191-7; PMID:17012876; http://dx.doi.org/10.4161/hv.1.5.2126
   PubMed Web of Science ®Google Scholar
• Schofield T. In vitro versus in vivo concordance: a case study of the replacement of an animal potency test with an immunochemical assay. Dev Biol 2002; 111:299-304; PMID:12678253
   PubMedGoogle Scholar
• Sitrin RD, Zhao Q, Potter CS, Carragher B, Washabaugh MW. Recombinant protein based viral vaccines, In Vaccine Analysis: Strategies, Principles and Control. Brian Nunnally et al. (eds.) Springer Verlag Berkub Heidelberg, 2015 . Chapter 3, Recombinant Virus-like Particle Protein Vaccines; p.81-112 (DOI: 10.1007/978-3-662-45024-6-3)
   Google Scholar
• Shank-Retzlaff ML, Zhao Q, Anderson C, Hamm M, High K, Nguyen M, Wang F, Wang N, Wang B, Wang Y, et al. Evaluation of the thermal stability of Gardasil. Hum Vaccin 2006; 2(4):147-54; PMID:17012891; http://dx.doi.org/10.4161/hv.2.4.2989
   PubMed Web of Science ®Google Scholar
• Zhao Q, Wang Y, Abraham D, Towne V, Kennedy R, Sitrin RD. Real time monitoring of antigenicity development of HBsAg virus-like particles (VLPs) during heat- and redox-treatment. Biochem Biophys Res Commun 2011; 408(3):447-53; PMID:21527246; http://dx.doi.org/10.1016/j.bbrc.2011.04.048
   PubMed Web of Science ®Google Scholar
• Zhao Q, Towne V, Brown M, Wang Y, Abraham D, Oswald CB, Gimenez JA, Washabaugh MW, Kennedy R, Sitrin RD. In-depth process understanding of RECOMBIVAX HB(R) maturation and potential epitope improvements with redox treatment: multifaceted biochemical and immunochemical characterization. Vaccine 2011; 29(45):7936-41; PMID:21871939; http://dx.doi.org/10.1016/j.vaccine.2011.08.070
   PubMed Web of Science ®Google Scholar
• Zhao Q, Modis Y, High K, Towne V, Meng Y, Wang Y, Alexandroff J, Brown M, Carragher B, Potter CS, et al. Disassembly and reassembly of human papillomavirus virus-like particles produces more virion-like antibody reactivity. Virol J 2012; 9:52; PMID:22356831; http://dx.doi.org/10.1186/1743-422X-9-52
   PubMed Web of Science ®Google Scholar
• Zhang J, Zhang X-F, Huang S-J, Wu T, Hu Y-M, Wang Z-Z, et al. Long-term efficacy of a hepatitis E vaccine. N Engl J Med 2015;372(10):914-22; PMID: 25738667; http://dx.doi.org/10.1056/NEJMoa1406011.
   Web of Science ®Google Scholar
• Zhang J, Zhang XF, Zhou C, Wang ZZ, Huang SJ, Yao X, Liang ZL, Wu T, Li JX, Yan Q, et al. Protection against hepatitis E virus infection by naturally acquired and vaccine-induced immunity. Clin Microbiol Infect 2014; 20(6):O397-405; PMID:24118636; http://dx.doi.org/10.1111/1469-0691.12419
   PubMed Web of Science ®Google Scholar
• Wu T, Huang SJ, Zhu FC, Zhang XF, Ai X, Yan Q, Wang ZZ, Yang CL, Jiang HM, Liu XH, et al. Immunogenicity and safety of hepatitis E vaccine in healthy hepatitis B surface antigen positive adults. Hum Vaccin Immunother 2013; 9(11):2474-9; PMID:23887167; http://dx.doi.org/10.4161/hv.25814
   PubMed Web of Science ®Google Scholar
• WHO Weekly epidemiological record, 2014, 89, 321-336.
   Google Scholar
• Wu T, Zhu FC, Huang SJ, Zhang XF, Wang ZZ, Zhang J, Xia NS. Safety of the hepatitis E vaccine for pregnant women: A preliminary analysis. Hepatology 2012; 55(6):2038; PMID:22161542; http://dx.doi.org/10.1002/hep.25522
   Web of Science ®Google Scholar
• Nelson KE, Shih JW, Zhang J, Zhao Q, Xia N, Ticehurst J, et al. Hepatitis E vaccine to prevent morbidity and mortality during epidemics. Open Forum Infect Dis 2014: 1(3): ofu098; PMID:25714510; PMID: 25734166; http://dx.doi.org/10.1093/ofid/ofu098
   Google Scholar