Hepatitis B vaccine containing surface antigen and selected preS1 and preS2 sequences. 1. Safety and immunogenicity in young, healthy adults

Vaccine

Volumn 15, Issue 16, 1997, Pages 1724-1731

  Leroux Roels, Geert ^a,b   Desombere, Isabelle ^a   De Tollenaere, Guido ^b   Petit, Marie Anne ^c   Desmons, Pierre ^d   Hauser, Pierre ^d   Delem, Andŕee ^d   De Grave, Danny ^d   Safary, Assad ^d  

^a GHENT UNIVERSITY   (Belgium)

^b GHENT UNIVERSITY HOSPITAL   (Belgium)

^c HÔPITAL PAUL BROUSSE   (France)

^d GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

Author keywords

Hepatitis B vaccine; Humoral and cellular immune response; PreS region

Indexed keywords

HEPATITIS B VACCINE; MEMBRANE ANTIGEN;

ADULT; ANTIBODY RESPONSE; ARTICLE; BELGIUM; CONTROLLED STUDY; FEMALE; HEPATITIS B; HEPATITIS B VIRUS; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; LYMPHOCYTE PROLIFERATION; MALE; NORMAL HUMAN; PRIORITY JOURNAL; SAFETY; SEROCONVERSION; VOLUNTEER;

ADULT; DOUBLE-BLIND METHOD; FEMALE; HEPATITIS B ANTIBODIES; HEPATITIS B SURFACE ANTIGENS; HEPATITIS B VACCINES; HUMANS; LYMPHOCYTE ACTIVATION; MALE; PROTEIN PRECURSORS;

EID: 0030768364     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0264-410X(97)00117-5     Document Type: Article

References (39)

1. André, F. E. Summary of safety and efficacy data on a yeast-derived hepatitis B vaccine. American Journal of Medicine 1989, 87, (suppl. 3A), 14S-20S.
2. Troisi, C. L. and Hollinger, F. B. Overview of clinical trials in low-endemic areas. In Hepatitis B Vaccines in Clinical Practice (Ed Ellis, R. W.). Marcel Dekker, New York, 1993, pp. 179-208
3. McMahon, B. J. and Wainwright, B. J. Protective efficacy of hepatitis B vaccines in infants, children and adults. In Hepatitis B Vaccines in Clinical Practice (Ed Ellis, R.W.). Marcel Dekker, New York, 1993, pp. 243-261
4. Heermann, K. H., Goldmann, U., Schwartz, W., Seyffarth, T., Baumgarten, H. and Gerlich, W. Large surface proteins of hepatitis B virus containing the pre-S sequence. Journal of Virology 1984, 52, 396-413.
5. Machida, A., Kishimoto, S., Ohnuma, H., Baba, K., Ito, Y., Miyamoto, H., Funatsu, G., Oda, K., Usuda, S., Togami, S., Nakamura, T., Miyakawa, Y. and Mayumi, M. A polypeptide containing 55 amino acid residues coded by the pre-S region of hepatitis B virus deoxyribonucleic acid bears the receptor for polymerized human as well as chimpanzee albumins. Gastroenterology 1984, 86, 910-918.
6. Vento, S., Rondanelli, E. G., Ranieri, S., O'Brien, C. J., Williams, R. and Eddleston, A. L.W. F. Prospective study of cellular immunity to hepatitis B virus antigens from the early incubation phase of acute hepatitis B. Lancet 1987, 2, 119-122.
7. Alberti, A., Pontisso, P., Schiavon, E. and Realdi, G. An antibody which precipitates Dane particles in acute hepatitis type B: relation to receptor sites which bind polymerized human serum albumin on virus particles. Hepatology 1984, 4, 220-226.
8. Budkowska, A., Dubreuil, P., Capel, F. and Pillot, J. Hepatitis B virus pre-S gene-encoded antigenic specificity and anti-pre-S antibody: relationship between anti-pre-S response and recovery. Hepatology 1986, 6, 360-368.
9. Okamoto, H., Usuda, S., Imai, M., Tachibana, K., Tanaka, E., Kumakura, T., Itabashi, M., Takai, E., Tsuda, F., Nakamura, T., Miyakawa, Y. and Mayumi, M. Antibody to the receptor for polymerized human serum albumin in acute and persistent infection with hepatitis B virus. Hepatology 1986, 6, 354-359.
10. Klinkert, M. Q., Theilmann, L., Pfaff, E. and Schaller, H. Pre-S1 antigens and antibodies early in the course of acute hepatitis B virus infection. Journal of Virology 1986, 58, 522-525.
11. Alberti, A., Cavalletto, D., Pontisso, P., Chemello, L., Tagariello, G. and Belussi, F. Antibody response to pre-S2 and hepatitis B virus induced liver damage Lancet 1988, 1, 1421-1424.
12. Itoh, Y., Takai, E., Ohnuma, H., Kitajima, K., Tsuda, F., Machida, A., Mishiro, S., Nakamura, T., Miyakawa, Y. and Mayumi, M. A synthetic peptide vaccine involving the product of the pre-S(2) region of hepatitis B virus DNA: protective efficacy in chimpanzees. Proceedings of the National Academy of Sciences of the United States of America 1986, 83, 9174-9178.
13. Emini, E. A., Larson, V., Eichberg, J., Conard, P., Garsky, V. M., Lee, D. R., Ellis, R. W., Miller, W. J., Anderson, C. A. and Gerety, R. J. Protective effect of a synthetic peptide comprising the complete preS2 region of the hepatitis B virus surface protein. Journal of Medical Virology 1989, 28, 7-12.
14. Neurath, A. R., Seto, B. and Strick, N. Antibodies to synthetic peptides from the pre-S1 region of the hepatitis B virus (HBV) envelope (env) protein are virus neutralizing and protective. Vaccine 1989, 7, 234-236.
15. Thornton, G. B., Moriarty, A. M., Milich, D. R., Eichberg, J. W., Purcell, R. H. and Gerin, J. L. Protection of chimpanzees from hepatitis B virus infection after immunization with synthetic peptides: identification of protective epitopes in the pre-S region. In Vaccines 89 (Eds Brown, F., Channock, T., Ginsberg, H. and Lerner, R.). Cold Spring Harbor Press, New York, 1989, pp. 467-470
16. Milich, D. R., Thornton, G. B., Neurath, A. R., Kent, S. B., Michel, M.-L., Tiollais, P. and Chisari, F. V. Enhanced immunogenicity of pre-S region of the hepatitis B virus antigen. Science 1985, 228, 1195-1199.
17. Neurath, A. R., Kent, S. B., Strick, N., Stark, D. and Sproul, P. Genetic restriction of immune responsiveness to synthetic peptides corresponding to sequences in the pre-S region of the hepatitis B virus (HBV) envelope gene. Journal of Medical Virology 1985, 17, 119-125.
18. Milich, D. R., McLachlan, A., Chisari, F. V., Kent, S. B. and Thornton, G. B. Immune response to the pre-S(1) region of the hepatitis B surface antigen (HBsAg): a pre-S(1) specific T cell response can bypass nonresponsiveness to the pre-S(2) and S regions of HBsAg. Journal of Immunology 1986, 137, 315-322.
19. Ferrari, C., Penna, A., Bertoletti, A., Cavalli, A., Valli, A., Schinachi, C. and Fiaccadori, F. The preS1 antigen of hepatitis B virus is highly immunogenic at the T cell level in man. Journal of Clinical Investigation 1989, 84, 1314-1319.
20. Neurath, A. R., Kent, S. B., Strick, N. and Parker, K. Identification and chemical synthesis of a host cell receptor binding site on hepatitis B virus. Cell 1986, 46, 429-436.
21. Ohnuma, H., Takahashi, K., Kishimoto, S., Machida, A., Imai, M., Mishiro, S., Usuda, S., Oda, K., Nakamura, T., Miyakawa, Y. and Mayumi, M. Large hepatitis B surface antigen polypeptides of Dane particles with the receptor for polymerized human serum albumin. Gastroenterology 1986, 90, 695-701.
22. Franco, A., Paroli, M., Testa, U., Benvenuto, R., Peschle, C., Balsano, F. and Barnaba, V. Transferrin receptor mediates uptake and presentation of hepatitis B envelope antigen by T lymphocytes. Journal of Experimental Medicine 1992, 175, 1195-1205.
23. Trevisan, A., Gudat, F., Guggenheim, R., Krey, G., Duermueller, U., Lueond, G., Dueggelin, M., Landmann, J., Tondelli, P. and Bianchi, L. Demonstration of albumin receptors on isolated human hepatocytes by light and scanning electron microscopy. Hepatology 1982, 2, 832-839.
24. Heermann, K. H., Waldeck, F. and Gerlich, W. H. Interaction between native human serum and the pre-S2 domain of hepatitis B virus surface antigen. In Viral Hepatitis and Liver Disease (Ed Zuckerman, A. J.). Alan R Liss, New York, 1988, pp. 697-700
25. Cabezon, T., Rutgers, T., Biemans, R., Vanderbrugge, D., Voet, P. and De Wilde, M. A new hepatitis B vaccine containing preS1 and preS2 epitopes from S. cerevisiae. In Vaccines 90 (Eds Brown, F., Chanock, R., Ginsberg, H. and Lerner, R.). Cold Spring Harbor Press, New York, 1990, pp. 199-203
26. De Wilde, M., Rutgers, T., Cabezon, T., Hauser, P., van Opstal, O., Harford, N., van Wijnendaele, F., Desmons, P., Comberbach, M., Roelants, P., Safary, A., Wiederman, G., Ambrosch, F., Voet, P., Delem, A. and Pêtre, J. PreS-containing HBsAg particles from Saccharomyces cerevisiae: production, antigenicity, and immunogenicity. In Viral Hepatitis and Liver Disease (Eds Hollinger, F. B., Lemon, S. M. and Margolis, H. S.). Williams and Wilkins, Baltimore, 1991, pp. 732-736
27. Hollinger, B., Adam, E., Heiberg, D. and Melnick, L. Response to hepatitis B vaccine in a young adult population. In Viral Hepatitis: 1981 International Symposium (Eds Szmuness, W., Alter, H. and Maynard, J.). Franklin Institute Press, Philadelphia, 1982, pp. 451-466
28. Petit, M. A., Dubanchet, S. and Capel, F. A monoclonal antibody specific for the hepatocyte receptor binding site on hepatitis B virus. Molecular Immunology 1989, 26, 531-537.
29. Leroux-Roels, G. G., Van Hecke, E., Michielsen, W., Voet, P., Hauser, P. and Pêtre, J. Correlation between in vivo humoral and in vitro cellular immune responses following immunization with hepatitis B surface antigen (HBsAg) vaccines. Vaccine 1994, 12, 812-818.
30. Milich, D. R., Leroux-Roels, G. G., Louie, R. E. and Chisari, F. V. Genetic regulation of the immune response to hepatitis B surface antigen (HBsAg). IV. Distinct H-2 linked Ir genes control antibody responses to different HBsAg determinants on the same molecule and map to the I-A and I-C subregions. Journal of Experimental Medicine 1984, 159, 41-56.
31. Cupps, T. R., Tibbles, J., Hurni, W. M., Miller, W. J., Ellis, R. E., Milich, D. and Wetter, N. In vitro T cell immune responses to the preS2 antigen of the hepatitis B virus envelope protein in preS2+S vaccine recipients. Journal of Immunology 1993, 151, 3353-3360.
32. Miskovsky, E., Gershman, K., Clements, M. L., Cupps, T., Calandra, G., Hesley, T., Ioli, V., Ellis, R., Kniskern, P., Miller, W., Gerety, R. and West, D. Comparative safety and immunogenicity of yeast recombinant hepatitis B vaccines containing S and preS2+S antigens. Vaccine 1991, 9, 346-350.
33. Suzuki, H., Iino, S., Shiraki, K., Akahane, Y., Okamoto, H., Domoto, K. and Mishiro, S. Safety and efficacy of a recombinant yeast-derived preS2+S-containing hepatitis B vaccine (TGP-943): phase 1, 2 and 3 clinical testing. Vaccine 1994, 12, 1090-1096.
34. Pillot, J., Poynard, T., Elias, A., Maillard, J., Lazizi, Y., Brancer, M., Dubreuil, P., Budkowska, A. and Chaput, J. C. Weak immunogenicity of the preS2 sequence and lack of circumventing effect on the unresponsiveness to the hepatitis B virus vaccine. Vaccine 1995, 13, 289-294.
35. Gerety, R. J. and West, D. J. Current and future hepatitis B vaccines. In Progress in Hepatitis B Immunization (Eds Coursaget, P. and Tong, M.J.). Colloque INSERM/John Libbey Eurotext Ltd., Paris/London, 1990, 194, pp. 215-225
36. Tron, F., Degos, F., Bréchot, C., Couroucé, A.-M., Goudeau, A., Marie, F.-N., Adamowicz, P., Saliou, P., Laplanche, A., Benhamou, J.-P. and Girard, M. Randomized dose range study of a recombinant hepatitis B vaccine produced in mammalian cells and containing the S and preS2 sequences. Journal of Infectious Diseases 1989, 160, 199-204.
37. Kuroda, S., Fujisawa, Y., Iino, S., Akahane, Y. and Suzuki, H. Induction of protection level of anti-pre-S2 antibodies in humans immunized with a novel hepatitis B vaccine consisting of M (pre-S2+S) protein particles (a third generation vaccine). Vaccine 1991, 9, 163-169.
38. Carman, W. F., Zanetti, A. R., Karayiannis, P., Waters, J., Manzillo, G., Tanzi, E., Zuckerman, A. and Thomas, H. C. Vaccine-induced escape mutant of hepatitis B virus. Lancet 1990, 336, 325-329.
39. Neurath, A. R., Kent, S. B., Parker, K., Prince A. M., Strick, N., Brotman, B. and Sproul, P. Antibodies to a synthetic peptide from the preS 120-145 region of the hepatitis B virus envelope are virus neutralizing. Vaccine 1986, 4, 35-37.