Comparable quality attributes of hepatitis E vaccine antigen with and without adjuvant adsorption-dissolution treatment

References

• Perez-Gracia MT, Mateos Lindemann ML, Caridad Montalvo Villalba M. Hepatitis E: current status. Reviews in medical virology 2013; 23:384–98
   Google Scholar
• Haim-Boukobza S, Coilly A, Sebagh M, Bouamoud M, Antonini T, Roche B, Yordanova O, Savary J, Saliba F, Duclos-Vallee JC, et al. Hepatitis E infection in patients with severe acute alcoholic hepatitis. Liver Int: Off J Int Assoc Study Liver 2014; in press http://dx.doi.org/10.1111/liv.12610
   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; 55:2038; PMID:22161542; http://dx.doi.org/10.1002/hep.25522
   PubMed Web of Science ®Google 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; 33:79-88; PMID:23564392; http://dx.doi.org/10.1055/s-0033-1338116
   PubMed Web of Science ®Google Scholar
• Wu T, Li SW, Zhang J, Ng MH, Xia NS, Zhao QJ. Hepatitis E vaccine development A 14-year odyssey. Hum Vacc Immunother 2012; 8:823-7; PMID:22699438; http://dx.doi.org/10.4161/hv.20042
   PubMed Web of Science ®Google Scholar
• Ma Y, Lin SQ, Gao Y, Li M, Luo WX, Zhang J, Xia NS. Expression of ORF2 partial gene of hepatitis E virus in tomatoes and immunoactivity of expression products. World J Gastroentero 2003; 9:2211-5
   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. Vaccine 2014; 32:4039-4050; PMID:24892250; http://dx.doi.org/10.1016/j.vaccine.2014.05.064
   PubMed Web of Science ®Google Scholar
• Li SW, Zhang J, Li YA, Ou SH, Huang GY, Huang GY, He ZQ, Ge SX, Xian YL, Pang SQ, et al. A bacterially expressed particulate hepatitis E vaccine: antigenicity, immunogenicity and protectivity on primates. Vaccine 2005; 23:2893-901; PMID:15780738; http://dx.doi.org/10.1016/j.vaccine.2004.11.064
   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; 376:895-902; PMID:20728932; http://dx.doi.org/10.1016/S0140-6736(10)61030-6
   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; 27:139-65; PMID:24396140; http://dx.doi.org/10.1128/CMR.00062-13
   PubMed 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: Off Pub Eur Soc Clin Microbiol Infect Dis 2014; 20:O309-405; PMID:24112138; http://dx.doi.org/10.1111/1469-0691.12257
   PubMedGoogle Scholar
• Kamili S. Toward the development of a hepatitis E vaccine. Virus Res 2011; 161:93-100; PMID:21620908; http://dx.doi.org/10.1016/j.virusres.2011.05.008
   PubMed Web of Science ®Google Scholar
• Myint KSA, Gibbons RV. Hepatitis E: a neglected threat. T Roy Soc Trop Med H 2008; 102:211-2; PMID:17658568; http://dx.doi.org/10.1016/j.trstmh.2007.03.014
   PubMedGoogle 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. New Engl J Med 2007; 356:895-903; PMID:17329696; http://dx.doi.org/10.1056/NEJMoa061847
   PubMed Web of Science ®Google Scholar
• Shirodkar S, Hutchinson RL, Perry DL, White JL, Hem SL. Aluminum compounds used as adjuvants in vaccines. Pharmaceut Res 1990; 7:1282-8; http://dx.doi.org/10.1023/A:1015994006859
   PubMed Web of Science ®Google Scholar
• Heimlich JM, Regnier FE, White JL, Hem SL. The in vitro displacement of adsorbed model antigens from aluminium-containing adjuvants by interstitial proteins. Vaccine 1999; 17:2873-81; PMID:10438058; http://dx.doi.org/10.1016/S0264-410X(99)00126-7
   PubMed Web of Science ®Google Scholar
• A bacterially expressed particulate hepatitis E vaccine: antigenicity im, J. V., White JL, Hem SL. Effect of pH on the elution of model antigens from aluminum-containing adjuvants. J Colloid Interf Sci 1998; 205:161-5; PMID:9710509; http://dx.doi.org/10.1006/jcis.1998.5648
   PubMedGoogle Scholar
• Jendrek S, Little SF, Hem S, Mitra G, Giardina S. Evaluation of the compatibility of a second generation recombinant anthrax vaccine with aluminum-containing adjuvants. Vaccine 2003; 21:3011-8; PMID:12798645; http://dx.doi.org/10.1016/S0264-410X(03)00109-9
   PubMed Web of Science ®Google Scholar
• Iyer S, Robinett RSR, HogenEsch H, Hem SL. Mechanism of adsorption of hepatitis B surface antigen by aluminum hydroxide adjuvant. Vaccine 2004; 22:1475-9; PMID:15063571; http://dx.doi.org/10.1016/j.vaccine.2003.10.023
   PubMed Web of Science ®Google Scholar
• Weissburg RP, Berman PW, Cleland JL, Eastman D, Farina F, Frie S, Lim A, Mordenti J, Nguyen TT, Peterson MR. Characterization of the Mn Gp120 HIV-1 vaccine - antigen-binding to alum. Pharmaceut Res 1995; 12:1439-46; PMID:8584477; http://dx.doi.org/10.1023/A:1016266916893
   PubMed Web of Science ®Google Scholar
• Rinella JV, White JL, Hem SL. Effect of pH on the elution of model antigens from aluminum-containing adjuvants. J Colloid Interf Sci 1998; 205:161-5; PMID:9710509; http://dx.doi.org/10.1006/jcis.1998.5648
   PubMed Web of Science ®Google Scholar
• Greiner VJ, Ronzon F, Larquet E, Desbat B, Esteves C, Bonvin J, Gréco F, Manin C, Klymchenko AS, Mély Y. The structure of HBsAg particles is not modified upon their adsorption on aluminium hydroxide gel. Vaccine 2012; 30:5240-5; PMID:22705175; http://dx.doi.org/10.1016/j.vaccine.2012.05.082
   PubMed Web of Science ®Google Scholar
• Rinella JV, Workman RF, Hermodson MA, White JL, Hem SL. Elutability of proteins from aluminum-containing vaccine adjuvants by treatment with surfactants. J Colloid Interf Sci 1998; 197:48-56; PMID:9466843; http://dx.doi.org/10.1006/jcis.1997.5230
   PubMed Web of Science ®Google Scholar
• Hutcheon CJ, Becker JO, Russell BA, Bariola PA, Peterson GJ, Stroop SD. Physiochemical and functional characterization of antigen proteins eluted from aluminum hydroxide adjuvant. Vaccine 2006; 24:7214-25; PMID:16860908; http://dx.doi.org/10.1016/j.vaccine.2006.06.043
   PubMed Web of Science ®Google 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 Vacc Immunother 2014; 10:734-9; PMID:24299977; http://dx.doi.org/10.4161/hv.27316
   PubMed Web of Science ®Google Scholar
• Tang XH, Yang CY, Gu Y, Song CL, Zhang X, Wang YB, Zhang J, Hew CL, Li S, Xia N, et al. Structural basis for the neutralization and genotype specificity of hepatitis E virus. P Natl Acad Sci USA 2011; 108:10266-71; 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; 23:2881-92; PMID:15780737; http://dx.doi.org/10.1016/j.vaccine.2004.11.065
   PubMed Web of Science ®Google 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; 32:2859-65; PMID:24662711; http://dx.doi.org/10.1016/j.vaccine.2014.02.025
   PubMed Web of Science ®Google Scholar
• Manek RV, Kunle OO, Emeje MO, Builders P, Rao GVR, Lopez GP, Kolling WM. Physical thermal and sorption profile of starch, obtained from Tacca leontopetaloides. Starch-Starke 2005; 57:55-61; http://dx.doi.org/10.1002/star.200400341
   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; 408:447-53; 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; 29:7936-41; 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; PMID:22356831; http://dx.doi.org/10.1186/1743-422X-9-52
   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 (TM), the AS04-adjuvanted HPV-16 and-18 cervical cancer vaccine. Hum Vaccines 2010; 6:407-19; PMID:20953154; http://dx.doi.org/10.4161/hv.6.5.11023
   PubMed Web of Science ®Google Scholar
• Robert DS, Qinjian Z, Clinton SP, Bridget C, Washabaugh MW. Recombinant protein based viral vaccines, In Vaccine Analysis: Strategies, Principles and Control. (Chapter 3) Brian N et al. eds. Taylor & FrancisTaylor & Francis, 2015; 81–112; http://dx.doi.org/10.1007/978-3-662-45024-6-3
   Google Scholar
• Chang MF, Shi Y, Nail SL, HogenEsch H, Adams SB, White JL, Hem SL. Degree of antigen adsorption in the vaccine or interstitial fluid and its effect on the antibody response in rabbits. Vaccine 2001; 19:2884-9; PMID:11282199; http://dx.doi.org/10.1016/S0264-410X(00)00559-4
   PubMed Web of Science ®Google Scholar
• Iyer S, HogenEsch H, Hem SL. Relationship between the degree of antigen adsorption to aluminum hydroxide adjuvant in interstitial fluid and antibody production. Vaccine 2003; 21:1219-23; PMID:12559801; http://dx.doi.org/10.1016/S0264-410X(02)00556-X
   PubMed Web of Science ®Google Scholar
• Shi Y, HogenEsch H, Hem SL. Change in the degree of adsorption of proteins by aluminum-containing adjuvants following exposure to interstitial fluid: freshly prepared and aged model vaccines. Vaccine 2001; 20:80-5; PMID:11567749; http://dx.doi.org/10.1016/S0264-410X(01)00313-9
   PubMedGoogle Scholar
• Rinella JV, White JL, Hem SL. Effect of anions on model aluminum-adjuvant-containing vaccines. J Colloid Interf Sci 1995; 172:121-30; http://dx.doi.org/10.1006/jcis.1995.1233
   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. Research paper correlation between mouse potency and in vitro relative potency for human papillomavirus type 16 virus-like particles and Gardasil® vaccine samples. Hum Vaccines 2005; 1:191-7; http://dx.doi.org/10.4161/hv.1.5.2126
   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; 31:654-63; PMID:24125746; http://dx.doi.org/10.1016/j.tibtech.2013.09.002
   PubMed Web of Science ®Google Scholar
• Tleugabulova D, Falcon V, Penton E. Evidence for the denaturation of recombinant hepatitis B surface antigen on aluminium hydroxide gel. J Chromatogr B, Biomed Sci Appl 1998; 720:153-63; PMID:9892077; http://dx.doi.org/10.1016/S0378-4347(98)00425-3
   PubMedGoogle Scholar
• Gupta RK, Chang AC, Griffin P, Rivera R, Siber GR. In vivo distribution of radioactivity in mice after injection of biodegradable polymer microspheres containing 14C-labeled tetanus toxoid. Vaccine 1996; 14:1412-6; PMID:8994315; http://dx.doi.org/10.1016/S0264-410X(96)00073-4
   PubMed Web of Science ®Google Scholar
• Weissburg RP, Berman PW, Cleland JL, Eastman D, Farina F, Frie S, Lim A, Mordenti J, Nguyen TT, Peterson MR. Characterization of the MN gp120 HIV-1 vaccine: antigen binding to alum. Pharm Res 1995; 12:1439-46; PMID:8584477; http://dx.doi.org/10.1023/A:1016266916893
   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
• 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 (R). Hum Vaccines 2006; 2:147-54; http://dx.doi.org/10.4161/hv.2.4.2989
   PubMed Web of Science ®Google Scholar
• Schofield T. In virto versus in vivo concordance: a case study of the replacement of an animal potency test with an immunochemical assay. In: Karger BF (ed) Advancing Science and Elimination of the Use of Laboratory Animals for Development and Control of Vaccines and Hormones, 2002; 111:299-304.
   Google Scholar
• Metz B, Hendriksen CFM, Jiskoot W, Kersten GFA. Reduction of animal use in human vaccine quality control: opportunities and problems. Vaccine 2002; 20:2411-30; PMID:12057596; http://dx.doi.org/10.1016/S0264-410X(02)00192-5
   PubMed Web of Science ®Google Scholar
• van der Kamp MD. Replacement, reduction or refinement of animal use in the quality control of veterinary vaccines: development, validation and implementation. Dev Biol Stand 1996; 86:73-6; PMID:8785994
   PubMedGoogle Scholar