Hepatitis B vaccine containing surface antigen and selected preS1 and preS2 sequences. 2. Immunogenicity in poor responders to hepatitis B vaccines

Vaccine

Volumn 15, Issue 16, 1997, Pages 1732-1736

  Leroux Roels, Geert ^a,b   Desombere, Isabelle ^a   Cobbaut, Luc ^b   Petit, Marie Anne ^c   Desmons, Pierre ^d   Hauser, Pierre ^d   Delem, Andrée ^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; Poor responsiveness; PreS region

Indexed keywords

HEPATITIS B VACCINE; MEMBRANE ANTIGEN; RECOMBINANT HEPATITIS B VACCINE;

ADULT; ANTIBODY RESPONSE; ARTICLE; CELLULAR IMMUNITY; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG RESPONSE; FEMALE; HEPATITIS B; HEPATITIS B VIRUS; HUMAN; IMMUNOGENICITY; MALE; PRIORITY JOURNAL; REVACCINATION; VACCINATION;

ADULT; ANTIBODY FORMATION; DOUBLE-BLIND METHOD; FEMALE; HEPATITIS B ANTIBODIES; HEPATITIS B SURFACE ANTIGENS; HEPATITIS B VACCINES; HUMANS; IMMUNITY, CELLULAR; MALE; MIDDLE AGED; PROTEIN PRECURSORS;

EID: 0030819395     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0264-410X(97)00118-7     Document Type: Article

References (29)

1. André, F. E. Summary of safety and efficacy data on a yeast-derived hepatitis B vaccine. American Journal of Medicine 1989, 87, (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. Szmuness, W., Stevens, C. E., Harley, E. J., Zang, E. A., Oleszko, W. R., William, D. C., Sadovsky, R., Morrison, J. M. and Kellner, A. Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States. New England Journal of Medicine 1980, 303, 833-841.
5. Francis, D. P., Hadler, S. C., Thompson, S. E., Maynard, J., Ostrow, D., Altman, N., Braff, E., O'Malley, P., Hawkins, D., Judson, F., Penley, K., Nylund, T., Christie, G., Meyers, F., Moore, J., Gardner, A., Doto, I., Miller, J., Reynolds, G., Murphy, B., Schable, C., Clark, B., Curran, J. and Redeker, A. The prevention of hepatitis B with vaccine: report of the Centers for Disease Control multicenter efficacy trial among homosexual men. Annals of International Medicine 1982, 97, 362-366.
6. Dienstag, J. L., Werner, B. G., Polk, B. F., Snydman, D. R., Craven, D. E., Platt, R., Crumpacker, C. S., Hellström, R. O. and Grady, G. F. Hepatitis B vaccine in health care personnel: safety, immunogenicity, and indicators of efficacy. Annals of International Medicine 1984, 101, 34-40.
7. Szmuness, W., Stevens, C. E., Harley, E. J., Zang, E., Alter, H., Taylor, P., DeVera, A., Chen, G. and Kellner, A. Hepatitis B vaccine in medical staff of hemodialysis units: efficacy and subtype cross-protection. New England Journal of Medicine 1982, 307, 1481-1486.
8. Sengar, D. P., McLeish, W. A., Sutherland, M., Couture, R. A. and Rashid, A. Hepatitis B antigen (HBAg) infection in a hemodialysis unit. I. HL-A8 and immune response to HBAg. CMA Journal 1975, 112, 968-969.
9. Walker, M., Szmuness, W., Stevens, C. and Rubinstein, P. Genetics of anti-HBs responsiveness. I. HLA-DR7 and non-responsiveness to hepatitis vaccination. Transfusion 1981, 21, 601
10. Craven, D. E., Awdeh, Z. L., Kunches, L. M., Yunis, E. J., Dienstag, J. L., Werner, B. G., Polk, B. F., Snydman, D. R., Platt, R., Crumpacker, C. S., Grady, G. F. and Alper, C. A. Nonresponsiveness to hepatitis B vaccine in health care workers. Results of revaccination and genetic typing. Annals of International Medicine 1986, 105, 356-360.
11. + suppressor T cells. Human Immunology 1988, 22, 9-17.
12. Alper, C. A., Kruskall, M. S., Marcus-Bagley, D., Craven, D. E., Katz, A. J., Brink, S. J., Dienstag, J. L., Awdeh, Z. and Yunis, E. J. Genetic prediction of nonresponse to hepatitis B vaccine. New England Journal of Medicine 1989, 321, 708-712.
13. Milich, D. R., Leroux-Roels, G. G. and Chisari, F. V. Genetic regulation of the immune response to hepatitis B surface antigen (HBsAg). II. Qualitative characteristics of the humoral immune response to the a, d and y determinants of HBsAg. Journal of Immunology 1983, 130, 1395-1400.
14. 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.
15. 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.
16. 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.
17. 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 (Ed Brown, F., Chanock, R., Ginsberg, H. and Lerner, R.). Cold Spring Harbor Press, New York, 1990, pp. 199-203.
18. 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.
19. Leroux-Roels, G., Desombere, I., de Tollenaere, G., Petit, M.-A., Desmons, P., Hauser, P., Delem, A., de Grave, D. and Safary, A. Hepatitis B vaccine containing surface antigen and selected preS1 and preS2 sequences. 1. Safety and immunogenicity in young, healthy adults. Vaccine 1997, 15, 1724-1731.
20. 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.
21. 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 virtu; envelope protein in preS2+S vaccine recipients. Journal of Immunology 1993, 151, 3353-3360.
22. Wismans, P., van Hattum, J., Stelling, T. Poel, J. and de Gast, G. C. Effect of supplementary vaccination in healthy non-responders to hepatitis B vaccination. Hepato-gastroenterology 1988, 35, 78-79.
23. Morris, C. A., Oliver, P. R., Reynolds, F. and Selkon, J. B. Intradermal hepatitis B immunization with a yeast-derived vaccine: serological response by age and sex. Epidemiology of Infection 1989, 103, 387-394.
24. Rogan, P. D. and Duguid, K. M. Immunisation of staff of a regional blood transfusion centre with a recombinant hepatitis B vaccine. Journal of Infection 1991, 22, 5-9.
25. Struve, J., Aronsson, B., Frenning, B., Forsgren, M. and Weiland, O. Seroconversion after additional vaccine doses to non-responders to three doses of intradermally or intramuscularly administered recombinant hepatitis B vaccine. Scandinavian Journal of Infectious Disease 1994, 26, 468-470.
26. Chiaramonte, M., Ngatchu, T., Majori, S., Baldo, V., Moschen, M. E., Renzulli, G. and Trivello, R. Response to an extra dose of hepatitis B vaccine and specific antibody persistence in non-responders to primary immunization. Scandinavian Journal of Gastroenterology 1995, 30, 601-603.
27. Hemmerling, A. E., Müller, R., Firusian, N., Grötz, J., Haubitz, M. and Thoma, H. A. Clinical experience with the preS1-containing hepatitis B vaccine (HG-3) in different non-responder groups. In Viral Hepatitis and Liver Disease (Eds Nishioka, K., Suzuki, H., Mishiro, S. and Oda, T.). Springer, Tokyo, 1994, pp. 540-542
28. 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.
29. 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.