Safety and immunogenicity of a hepatitis B vaccine formulated with a novel adjuvant system

Vaccine

Volumn 16, Issue 7, 1998, Pages 708-714

  Thoelen, S ^a   Van Damme, P ^a   Mathei, C ^a   Leroux Roels, G ^b   Desombere, I ^b   Safary, A ^c   Vandepapeliere, P ^c   Slaoui, M ^c   Meheus, A ^a  

^a UNIVERSITY OF ANTWERP   (Belgium)

^b GHENT UNIVERSITY   (Belgium)

^c GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

Author keywords

Adjuvant; Hepatitis B vaccine; SBAS4

Indexed keywords

HEPATITIS B VACCINE;

ADULT; ANTIBODY TITER; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; FEMALE; HEPATITIS B; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INFECTION PREVENTION; INJECTION PAIN; INTRAMUSCULAR DRUG ADMINISTRATION; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADJUVANTS, IMMUNOLOGIC; ADULT; ALUMINUM COMPOUNDS; ANTIBODIES, FUNGAL; ANTIBODY FORMATION; DOUBLE-BLIND METHOD; FEMALE; HEPATITIS B SURFACE ANTIGENS; HEPATITIS B VACCINES; HUMANS; IMMUNITY, CELLULAR; LIPID A; MALE;

EID: 0032054151     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0264-410X(97)00254-5     Document Type: Article

References (27)

1. 1 Kane, M.A., Clements, J. and Hu. D. Hepatitis B. In: Disease Control Priorities in Developing Countries. A World Bank book (Eds Jamisor, D.T., Mosley, W.H., Measham, A.R. and Bobadilla, J.L.). Oxford University Press, New York, 1993, pp. 321-330.
2. 2 Maynard, J.E., Kane, M.A. and Hadler, S.C. Global control of hepatitis B through vaccination: the role of hepatitis B vaccine in the Expanded Programme on Immunization. Rev. Infect. Dis. 1989, 2, (Suppl. 3), S574-S575.
3. 3 Szmuness, W., Stevens, C.E., Zang, E.A., Harley, E.J. and Kellner, A. A controlled clinical trial of the efficacy of the hepatitis B vaccine (Heptavax B): a final report. Hepatology 1981, 1, 377-385.
4. 4 Stéphenne, J. Recombinant versus plasma-derived hepatitis B vaccines: issues of safety, immunogenicity and cost effectiveness. Vaccine 1988, 6, 299-303.
5. 5 Goilav, C., Prinsen, H., Safary, A., André, F.E. and Piot, P. Immunisation of homosexual men with a recombinant DNA vaccine against hepatitis B: immunogenicity and protection. In: Viral Hepatitis and Liver Disease (Ed. Zuckerman, A.J.). Alan Liss, Inc., New York, 1988, pp. 1057-1058.
6. 6 Hadler, S., Francis, D. and Maynard, J. et al. Longterm immunogenicity and efficacy of hepatitis B vaccine in homosexual men. N. Engl. J. Med. 1986, 315, 209-214.
7. 7 Van Damme, P., Vranckx, R., Safary, A., André, F.E. and Meheus, A. Protective efficacy of recombinant deoxyribonucleic acid hepatitis B vaccine in institutionalised mentally handicapped clients. Am. J. Med. 1989, 87, (3A), 26S-29S.
8. 8 Poovorawan, Y., Sanpavat, S., Pongpunlert, W., Chumdermpadetstuk, S., Sentrakel, P. and Safary, A. Protective efficacy of a recombinant DNA hepatitis B vaccine in neonates of HBeAg positive mothers. JAMA 1989, 261, 3278-3281.
9. 9 Hollinger, B.F. Factors influencing the immune response to hepatitis B vaccine, booster dose guidelines and vaccine protocol recommendations. Am. J. Med. 1989, 87, (Suppl. 3A), 36-40.
10. 10 Gupta, R. and Siber, G.R. Adjuvants for human vaccines - current status, problems and future prospects. Vaccine 1995, 13, 1263-1273.
11. 11 Rudbach, J.A., Myers, K.R., Rechtman, D.J. and Ulrich, J.T. Prophylactic use of mono-phosphoryl lipid A in patients at risk for sepsis. In: Gram Negative Sepsis: Basic Science to Clinical Intervention (Ed. Liven, J.). Wiley-Liss, Inc., New York, 1994 (preprint).
12. 12 Ribi, E., Cantrell, J. and Feldner, T. Biological activities of monophosphoryl Lipid A. In: Microbiology 1986 (Eds Levine, L., Bonventre, P.F. and Morello, J.A.). Washington DC, 1986, pp. 9-13.
13. 13 Myers, K.R., Truchot. A, T. and Ward, J. A critical determinant of lipid A endotoxic activity. In: Cellular and Molecular Aspects of Endotoxin Reactions: Proceedings of the first Congress of the International Endotoxin Society, 1990 (Ed. Nowotny, A.). Elsevier, Amsterdam, 1990, pp. 145-156.
14. 14 Tomai, M.A., Solem, L.E., Johnson, A.G. and Ribi, E. The adjuvant properties of a non-toxic monophosphoryl lipid A in hyporesponsive and aging mice. J. Biol. Resp. Modifiers 1987, 6, 99.
15. 15 Sager, P. Current protocols for enhancing the immune response in rabbits. J. NIH Res. 1993, 5, 82.
16. 16 Hollinger, F.B., Adam, E., Heiberg, D. and Melnick, J.L. Response to Hepatitis B vaccine in a young adult population. In: Viral Hepatitis (Eds Szumess, W., Alter, H., Maynard, J.E.). Franklin Institute Press, Philadelphia, 1982, pp. 451-466.
17. 17 West, D.J. and Calandra, G.B. Vaccine induced immunologic memory for hepatitis B surface antigen: implications for policy on booster vaccination. Vaccine 1996, 11, 1019-1025.
18. 18 Howard, P.A. and Haley, C. Duration of immunity from hepatitis B vaccine. Drug Intell. and Clin. Pharm. 1988, 22, (12), 985-987.
19. 19 Collaborators of the International Group Immunisation against hepatitis B. Lancet 1988, 1, 875-876.
20. 20 Advisory Committee on Immunization Practices Recommendations for protection against viral hepatitis. MMWR 1985, 34, (22), 313-335.
21. 21 Advisory Committee on Immunization Practices Update on hepatitis B prevention. MMWR 1987, 36, (23), 353-367.
22. 22 Leroux-Roels, 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, 811-818.
23. 23 Tilzey, A.J., Laidler, P.W. and Banatvala, J.E. Reactogenicity and immunogenicity of a yeast-derived recombinant DNA hepatitis B vaccine in healthy young adults. In: Viral Hepatitis and Liver Disease (Ed. Zuckerman, A.J.). Alan Liss, Inc., New York, 1988, pp. 1047-1049.
24. 24 Crovari, P., Cuneo-Crovari, P., Icardi, G.C., Bonanni, P. and Coppola, R.C. Immunization of young adults with two yeast-drived hepatitis B vaccines. In: Viral Hepatitis and Liver Disease (Ed. Zuckerman, A.J.). Alan Liss, Inc., New York, 1988, 1071-1073.
25. 25 Wismans, P., van Hattum, J. and de Gast, G. et al. The spot-ELISA: a sensitive in vitro method to study the immune response to hepatitis B surface antigen. Clin. Exp. Immunol. 1989, 78, 75-78.
26. 26 Wismans, P., van Hattum, J. and de Gast, G. et al. A prospective study of in vitro anti-HBs producing B cells (spot-ELISA) following primary and supplementary vaccination with recombinant hepatitis B vaccine in insulin-dependent diabetic patients and matched controls. J. Med. Virol. 1991, 35, 216-222.
27. 27 Tilzey, A.J. Hepatitis B vaccine boosting: the debate continues. Lancet 1995, 345, 1000-1001.