Immunogenicity and adverse effects of inactivated virosome versus alum-adsorbed hepatitis A vaccine: A randomized controlled trial

Vaccine

Volumn 14, Issue 10, 1996, Pages 982-986

  Holzer, Benedikt R ^a   Hatz, Christoph ^b   Schmidt Sissolak, Dagmar ^b   Glück, Reinhard ^c   Althaus, Beat ^c   Egger, Matthias ^a  

^a UNIVERSITY OF BERN   (Switzerland)

^b SWISS TROPICAL AND PUBLIC HEALTH INSTITUTE   (Switzerland)

^c Berna Biotech AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ALUMINUM POTASSIUM SULFATE; HEMAGGLUTININ; HEPATITIS A VACCINE; INACTIVATED VIRUS VACCINE; PHOSPHATIDYLCHOLINE; PHOSPHATIDYLETHANOLAMINE;

ADSORPTION; ADULT; ANTIBODY BLOOD LEVEL; ANTIBODY RESPONSE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; FEVER; HEADACHE; HEPATITIS A; HUMAN; IMMUNOGENICITY; INJECTION PAIN; INTRAMUSCULAR DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALAISE; MALE; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; VACCINATION;

EID: 0030197965     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/0264-410X(96)00042-4     Document Type: Article

References (28)

1. 1 Gupta, R.K., Relyveld, E.H., Lindblad, E.B., Bizzini, B., Ben-Efraim, S. and Gupta, C.K. Ajuvants - a balance between toxicity and adjuvanticity. Vaccine 1993, 11, 293-306
2. 2 Glück, R. Immunopotentiating reconstituted influenza virosomes (IRIVs) and other adjuvants for improved presentation of small antigens. Vaccine 1992, 10, 915-919
3. 3 Lowell, G.H. Proteosomes, hydrophobic anchors, iscoms, and liposomes for improved presentation of peptide and protein vaccines. In: New Generation Vaccines (Eds Woodrow G.C. and Levine M.M.). Marcel Dekker, New York, 1990, pp. 141-160
4. 4 Glück, R., Mischler, R., Finkel, B., Que, J.U., Scarpa, B. and Cryz, S.J. Immunogenicity of a new virosome influenza vaccine in elderly people. Lancet 1994, 344, 160-163
5. 5 Perrin, P., Thibodeau, L., Dauget, C., Fritsch, A. and Sureau, P. Amplification des proprétés immunogènes de la glycoprotéine rabique par ancrage sur des liposomes preformés. Ann. Virol. (Inst. Pasteur) 1984, 135E, 183-199
6. 6 Lawman, M.J.P., Naylor, P.T., Huang, L., Courtney, R.J. and Rouse, B.T. Cell-mediated immunity to herpes simplex virus: induction of cytotoxic T lymphocyte responses by viral antigens incorporated into liposomes. J. Immun. 1981, 126, 304-308
7. 7 Glück, R., Mischler, R., Brantschen, S., Just, M., Althaus, B. and Cryz, S.J.Jr Immunopotentiating reconstituted influenza virosome (IRIV) vaccine delivery system for immunization against hepatitis A. J. Clin. Invest. 1992, 90, 2491-2495
8. 8 Wiley, D.C. and Skehel, J.J. The structure and function of the hemagglutinin membrane glycoprotein of influenza virus. A. Rev. Biochem. 1987, 56, 365-394
9. 9 Siegl, G., Frösner, G.G., Gauss-Müller, V., Tratschin, J.-D. and Deinhardt, F. The physicochemical properties of infectious hepatitis A virions. J. Gen. Virol. 1981, 57, 331-341
10. 10 Loutan, L., Bovier, P., Althaus, B. and Glück, R. Inactivated virosome hepatitis A vaccine. Lancet 1994, 343, 322-324
11. 11 André, F.E., D'Hondt, E., Delem, A. and Safary, A. Clinical assessment of the safety and efficacy on an inactivated hepatitis A vaccine: rationale and summary of findings. Vaccine 1992, 10Suppl. 1, S160-S168
12. 12 Briem, H., Wynen, J. and Safary, A. Immunogenicity and reactogenecity of a hepatitis A virus (HAV) vaccine administered as a single dose with a booster at 6 months. International Symposium on Viral Hepatitis and Liver Disease, Tokyo 1993, abstract 048
13. 13 Bovier, P., Loutan, L., Farinelli, T, Herzog, C. and Glueck, R. Cross-immunogenicity and tolerance of two inactivated vaccines against hepatitis A virus. European Conference on Tropical Medicine, Hamburg 1995, abstract C41
14. 14 Berger, R. and Just, M. Vaccination against hepatitis A: control 3 years after the first vaccination. Vaccine 1992, 10, 295
15. 15 Just, M., Berger, R., Drechsler, H., Brantschen, S. and Glück, R. A single vaccination with an inactivated hepatitis A liposome vaccine induces protective antibodies after only two weeks. Vaccine 1992, 10, 737-739
16. 16 Goubau, P., Van Gerven, V., Safary, A. et al. Effect of virus strain and antigen dose on immunogenicity and reactogenicity of an inactivated hepatitis A vaccine. Vaccine 1992, 10Suppl. 1, S114-S118
17. 17 Dukes M.N.G. (Ed.) Meyler's Side Effects of Drugs. An Encyclopedia of Adverse Reactions and Interactions. Elsevier, Amsterdam, 1992
18. 18 Ambrosch, F., Widermann, G., André, F.E., D'Hondt, E., Delem, A. and Safary, A. Comparison of HAV antibodies induced by vaccination, passive immunization, and natural infection. In: Viral Hepatitis and Liver Disease (Eds Hollinger F.B., Lemon S.M. and Margolis H.S.). Williams and Wilkins, Baltimore, 1991
19. 19 Lemon, S.M. and Stapleton, J.T. Prevention of hepatitis A. In: Viral Hepatitis (Ed. Zuckerman A.). Churchill Livingstone, Edinburgh, 1993, pp. 61-79
20. 20 Just, M., Gremmelmaier, D., Berger, R., Collard, F. and Safary, A. Safety and immunogenicity of dose of inactivated hepatitis A vaccine in healthy adults. International Symposium on Viral Hepatitis and Liver Disease, Tokyo 1993, abstract 029
21. 21 Beach, M.L. and Meier, P. Choosing covariates in the analysis of clinical trials. Cont. Clin. Trials 1989, 10, 161S-175S
22. 22 Altman, D.G. Comparability of randomised groups. Statistician 1985, 34, 125-136
23. 23 Buyse, M.E. Analysis of clinical trial outcomes: some comments on subgroup analyses. Cont. Clin. Trials 1989, 10, 187S-194S
24. 24 Pocock, S.J. Clinical Trials. A Practical Approach, John Wiley and Sons, Chichester, 1983
25. 25 Steffen, R., Kane, M.A., Shapiro, C.N., Billo, N., Schoellhorn, K.J. and van Damme, P. Epidemiology and prevention of hepatitis A in travellers. J. Am. Med. Assoc. 1994, 272, 885-889
26. 26 Behrens, R.H. and Roberts, J.A. Is travel prophylaxis worth while? Economic appraisal of prophylactic measures against malaria, hepatitis A, and typhoid in travellers. Br. Med. J. 1994, 309, 1918-1922
27. 27 Lemon, S.M. Inactivated hepatitis A vaccines. J. Am. Med. Assoc. 1993, 271, 1363-1364
28. 28 Holzer, B.R. and Egger, M. Hepatitis A vaccine. Curr. Opinion. Inf. Dis. 1995, 8, 186-190