Posintro™-HBsAg, a modified ISCOM including HBsAg, induces strong cellular and humoral responses

International Journal of Pharmaceutics

Volumn 414, Issue 1-2, 2011, Pages 312-320

  Schiött, Åsa ^a   Larsson, Kristina ^b   Manniche, Søren ^a   Kalliomäki, Suzanne ^c   Heydenreich, Annette Vinther ^a   Dalsgaard, Kristian ^c   Kirkby, Nikolai ^b  

^a Nordic Vaccine A/S   (Denmark)

^b UNIVERSITY OF COPENHAGEN   (Denmark)

^c INVITEC ^*  (Denmark)

Author keywords

Adjuvant; HBsAg; Hepatitis B; ISCOM; Posintro ; Vaccine

Indexed keywords

CYTOKINE; GAMMA INTERFERON; HEPATITIS A HEPATITIS B VACCINE; HEPATITIS B SURFACE ANTIGEN; HEPATITIS B VACCINE; IMMUNOLOGICAL ADJUVANT; NANOPARTICLE; PHOSPHORYL LIPID A; POSINTRO; UNCLASSIFIED DRUG;

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ANTIBODY TITER; ANTIGEN SPECIFICITY; ARTICLE; CD4+ T LYMPHOCYTE; CD8+ T LYMPHOCYTE; CELLULAR IMMUNITY; CONTROLLED STUDY; CYTOKINE PRODUCTION; CYTOTOXIC T LYMPHOCYTE; DRUG FORMULATION; ENZYME LINKED IMMUNOSORBENT ASSAY; ENZYME LINKED IMMUNOSPOT ASSAY; FEMALE; GUINEA PIG; HEPATITIS B; HEPATITIS B VIRUS; HUMORAL IMMUNITY; IMMUNE RESPONSE; IMMUNE STIMULATORY COMPLEX; IMMUNIZATION; IMMUNOSTIMULATION; MOUSE; NONHUMAN; PRIORITY JOURNAL; T LYMPHOCYTE SUBPOPULATION; TH1 CELL; TRANSMISSION ELECTRON MICROSCOPY; VACCINATION; VIRUS INFECTION;

ADJUVANTS, IMMUNOLOGIC; ANIMALS; ANTIBODY FORMATION; FEMALE; GUINEA PIGS; HEPATITIS B; HEPATITIS B SURFACE ANTIGENS; HEPATITIS B VACCINES; HEPATITIS B VIRUS; IMMUNITY, CELLULAR; ISCOMS; LIPID A; LYMPHOCYTE ACTIVATION; MASTOCYTOMA; MICE; MICE, INBRED BALB C; SAPONINS; T-LYMPHOCYTES; T-LYMPHOCYTES, CYTOTOXIC; TUMOR CELLS, CULTURED;

EID: 79959712549     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2011.05.026     Document Type: Article

References (44)

1. A. Aguila, A.M. Donachie, M. Peyre, C.P. McSharry, D. Sesardic, and A.M. Mowat Induction of protective and mucosal immunity against diphtheria by a immune stimulating complex (ISCOMS) based vaccine Vaccine 24 2006 5201 5210 (Pubitemid 43818190)
2. S.M. Akbar, K. Kajino, K. Tanimoto, K. Kurose, T. Masumoto, K. Michitaka, N. Horiike, and M. Onji Placebo-controlled trial of vaccination with hepatitis B virus surface antigen in hepatitis B virus transgenic mice J. Hepatol. 26 1997 131 137 (Pubitemid 27072614)
3. M.R. Alderson, P. McGowan, J.R. Baldridge, and P. Probst TLR4 agonists as immunomodulatory agents J. Endotoxin Res. 12 2006 313 319 (Pubitemid 47471343)
4. L. Bandholtz, M.R. Kreuger, C. Svanholm, H. Wigzell, and M.E. Rottenberg Adjuvant modulation of the immune responses and the outcome of infection with Chlamydia pneumoniae Clin. Exp. Immunol. 130 2002 393 403 (Pubitemid 35418321)
5. J. Beran Safety and immunogenicity of a new hepatitis B vaccine for the protection of patients with renal insufficiency including pre-haemodialysis and haemodialysis patients Expert Opin. Biol. Ther. 8 2008 235 247 (Pubitemid 351233716)
6. M.R. Betts, J.M. Brenchley, D.A. Price, S.C. De Rosa, D.C. Douek, M. Roederer, and R.A Koup Sensitive and viable identification of antigen-specific CD8+ T cells by a flow cytometric assay for degranulation J. Immunol. Methods 281 2003 65 78 (Pubitemid 37324571)
7. J.P. Bryan, P.G. Craig, L. Reyes, S. Hakre, R. Jaramillo, H. Harlan, P. MacArthy, and L.J. Legters Randomized comparison of 5 and 10 microgram doses of two recombinant hepatitis B vaccines Vaccine 13 1995 978 982
8. I. Couillin, S. Pol, M. Mancini, F. Driss, C. Brechot, P. Tiollais, and M.L. Michel Specific vaccine therapy in chronic hepatitis B: induction of T cell proliferative responses specific for envelope antigens J. Infect. Dis. 180 1999 15 26 (Pubitemid 29293912)
9. Dalsgaard, K.; Henry, M.; San Martin Gamboa, R.M.; Grande, H.J.; Kamstrup, S.; 1995. Compounds with Adjuvant Activity. Patent Application WO 95/09179.
10. F. Gavilanes, J.M. Gonzalez-Ros, and D.L. Peterson Structure of hepatitis B surface antigen. Characterization of the lipid components and their association with the viral proteins J. Biol. Chem. 257 1982 7770 7777 (Pubitemid 12002791)
11. X.J. Guan, X.J. Guan, Y.Z. Wu, Z.C. Jia, T.D. Shi, and Y. Tang Construction and characterization of an experimental ISCOMS-based hepatitis B polypeptide vaccine World J. Gastroenterol. 8 2002 294 297 (Pubitemid 34428622)
12. L.G. Guidotti The role of cytotoxic T cells and cytokines in the control of hepatitis B virus infection Vaccine 20 2002 A80 82
13. L.G. Guidotti, K. Ando, M.V. Hobbs, T. Ishikawa, L. Runkel, R.D. Schreiber, and F.V. Chisari Cytotoxic T lymphocytes inhibit hepatitis B virus gene expression by a noncytolytic mechanism in transgenic mice Proc. Natl. Acad. Sci. U.S.A. 91 1994 3764 3768 (Pubitemid 24139512)
14. L.G. Guidotti, T. Ishikawa, M.V. Hobbs, B. Matzke, R. Schreiber, and F.V. Chisari Intracellular inactivation of the hepatitis B virus by cytotoxic T lymphocytes Immunity 4 1996 25 36 (Pubitemid 26054933)
15. L.G. Guidotti, R. Rochford, J. Chung, M. Shapiro, R. Purcell, and F.V. Chisari Viral clearance without destruction of infected cells during acute HBV infection Science 284 1999 825 829 (Pubitemid 29291352)
16. K. Heeg, W. Kuon, and H. Wagner Vaccination of class I major histocompatibility complex (MHC)-restricted murine CD8+ cytotoxic T lymphocytes towards soluble antigens: immunostimulating-ovalbumin complexes enter the class I MHC-restricted antigen pathway and allow sensitization against the immunodominant peptide Eur. J. Immunol. 21 1991 1523 1527
17. S. Hoglund, K. Dalsgaard, K. Lovgren, B. Sundquist, A. Osterhaus, and B. Morein ISCOMs and immunostimulation with viral antigens Subcell Biochem. 15 1989 39 68
18. C.R. Howard, B. Sundquist, J. Allan, S.E. Brown, S.H. Chen, and B. Morein Preparation and properties of immune-stimulating complexes containing hepatitis B virus surface antigen J. Gen. Virol. 68 1987 2281 2289 (Pubitemid 17129224)
19. C.R. Kensil, U. Patel, M. Lennick, and D. Marciani Separation and characterization of saponins with adjuvant activity from Quillaja saponaria Molina cortex J. Immunol. 146 1991 431 437
20. C.L. Lai, R.N. Chien, N.W. Leung, T.T. Chang, R. Guan, D.I. Tai, K.Y. Ng, P.C. Wu, J.C. Dent, J. Barber, S.L. Stephenson, and D.F. Gray A one-year trial of lamivudine for chronic hepatitis B Asia Hepatitis Lamivudine Study Group N Engl. J. Med. 339 1998 61 68 (Pubitemid 28304879)
21. A.S. Lok, H.T. Chung, V.W. Liu, and O.C. Ma Long-term follow-up of chronic hepatitis B patients treated with interferon alfa Gastroenterology 105 1993 1833 1838 (Pubitemid 24002802)
22. M.K. Maini, C. Boni, C.K. Lee, J.R. Larrubia, S. Reignat, G.S. Ogg, A.S. King, J. Herberg, R. Gilson, A. Alisa, R. Williams, D. Vergani, N.V. Naoumov, C. Ferrari, and A. Bertoletti The role of virus-specific CD8(+) cells in liver damage and viral control during persistent hepatitis B virus infection J. Exp. Med. 191 2000 1269 1280 (Pubitemid 30227116)
23. H. McClary, R. Koch, F.V. Chisari, and L.G. Guidotti Relative sensitivity of hepatitis B virus and other hepatotropic viruses to the antiviral effects of cytokines J. Virol. 74 2000 2255 2264 (Pubitemid 30091480)
24. G. Missale, A. Redeker, J. Person, P. Fowler, S. Guilhot, H.J. Schlicht, C. Ferrari, and F.V. Chisari HLA-A31- and HLA-Aw68-restricted cytotoxic T cell responses to a single hepatitis B virus nucleocapsid epitope during acute viral hepatitis J. Exp. Med. 177 1993 751 762 (Pubitemid 23104286)
25. B. Morein The iscom antigen-presenting system Nature 332 1988 287 288
26. B. Morein, B. Sundquist, S. Hoglund, K. Dalsgaard, and A. Osterhaus Iscom, a novel structure for antigenic presentation of membrane proteins from enveloped viruses Nature 308 1984 457 460 (Pubitemid 14130919)
27. T. Moriyama, S. Guilhot, K. Klopchin, B. Moss, C.A. Pinkert, R.D. Palmiter, R.L. Brinster, O. Kanagawa, and F.V. Chisari Immunobiology and pathogenesis of hepatocellular injury in hepatitis B virus transgenic mice Science 248 1990 361 364
28. A.M. Mowat, A.M. Donachie, G. Reid, and O. Jarett Immune-stimulating complexes containing Quil A and protein antigen prime class I MHC-restricted T lymphocytes in vivo and are immunogenic by the oral route Immunology 72 1991 317 322
29. G. Ott, G.L. Barchfeld, D. Chernoff, R. Radhakrishnan, P. van Hoogevest, and G. Van Nest MF59. Design and evaluation of a safe and potent adjuvant for human vaccines Pharm. Biotechnol. 6 1995 277 296
30. R.S. Pandey, and V.K. Dixit Evaluation of ISCOMs for immunization against hepatitis B Curr. Pharm. Biotechnol. 10 2009 709 716
31. L.J. Peek, C.R. Middaugh, and C. Berkland Nanotechnology in vaccine delivery Adv. Drug Deliv. Rev. 60 2008 915 928
32. A. Penna, F.V. Chisari, A. Bertoletti, G. Missale, P. Fowler, T. Giuberti, F. Fiaccadori, and C. Ferrari Cytotoxic T lymphocytes recognize an HLA-A2-restricted epitope within the hepatitis B virus nucleocapsid antigen J. Exp. Med. 174 1991 1565 1570
33. S. Pol, B. Nalpas, F. Driss, M.L. Michel, P. Tiollais, J. Denis, and C. Brecho Efficacy and limitations of a specific immunotherapy in chronic hepatitis B J. Hepatol. 34 2001 917 921 (Pubitemid 32595193)
34. B. Rehermann, C. Pasquinelli, S.M. Mosier, and F.V. Chisari Hepatitis B virus (HBV) sequence variation of cytotoxic T lymphocyte epitopes is not common in patients with chronic HBV infection J. Clin. Invest. 96 1995 1527 1534
35. R. Schirmbeck, J. Wild, and J. Reimann Similar as well as distinct MHC class I-binding peptides are generated by exogenous and endogenous processing of hepatitis B virus surface antigen Eur. J. Immunol. 28 1998 4149 4161 (Pubitemid 28558645)
36. C. Seeger, and W.S. Mason Hepatitis B virus biology Microbiol. Mol. Biol. Rev. 64 2000 51 68 (Pubitemid 30143840)
37. N. Shimada, K. Yamamoto, M.J. Kuroda, R. Terada, T. Hakoda, H. Shimomura, H. Hata, E. Nakayama, and Y. Shiratori HBcAg-specific CD8 T cells play an important role in virus suppression, and acute flare-up is associated with the expansion of activated memory T cells J. Clin. Immunol. 23 2003 223 232 (Pubitemid 36521216)
38. M. Singh, M. Ugozzoli, J. Kazzaz, J. Chesko, E. Soenawan, D. Mannucci, F. Titta, M. Contorni, G. Volpini, G. Del Guidice, and D.T. O'Hagan A preliminary evaluation of alternative adjuvants to alum using a range of established and new generation vaccine antigens Vaccine 24 2006 1680 1686 (Pubitemid 43238245)
39. H. Takahashi, T. Takeshita, B. Morein, S. Putney, R.N. Germain, and J.A. Berzofsky Induction of CD8+ cytotoxic T cells by immunization with purified HIV-1 envelope protein in ISCOMs Nature 344 1990 873 875
40. J.T. Ulrich, W. Cieplak, N.J. Paczkowski, S.M. Taylor, and S.D. Sanderson Induction of an antigen-specific CTL response by a conformationally biased agonist of human C5a anaphylatoxin as a molecular adjuvant J. Immunol. 164 2000 5492 5498 (Pubitemid 30305234)
41. R.S. van Binnendijk, C.A. van Baalen, M.C. Poelen, P. de Vries, J. Boes, V. Cerundolo, A.D. Osterhaus, and F.G UytdeHaag Measles virus transmembrane fusion protein synthesized de novo or presented in immunostimulating complexes is endogenously processed for HLA class I- and class II-restricted cytotoxic T cell recognition J. Exp. Med. 176 1992 119 128
42. P. Van Damme, and M. Van der Wielen Combining hepatitis A and B vaccination in children and adolescents Vaccine 19 2001 2407 2412 (Pubitemid 32234250)
43. M. Van der Wielen, P. Van Damme, R. Chlibek, J. Smetana, and F. von Sonnenburg Hepatitis A/B vaccination of adults over 40 years old: comparison of three vaccine regimens and effect of influencing factors Vaccine 24 2006 5509 5515 (Pubitemid 43831382)
44. J.F. Wu, T.C. Wu, C.H. Chen, Y.H. Ni, H.L. Chen, H.Y. Hsu, and M.H. Chang Serum levels of interleukin-10 and interleukin-12 predict early, spontaneous hepatitis B virus e antigen seroconversion Gastroenterology 138 2010 e161 163