[Immunogenicity and stability of an aluminum-free liposomal hepatitis A vaccine (Epaxal Berna)].
The high immunogenicity of the liposomal hepatitis A vaccine (Epaxal Berna) after a single dose and after a booster dose one year later has been confirmed in several studies with healthy adult volunteers: 95-100% and 96-100% seroconversion (> or = 20 mIE/ml) after 1 and 12 months respectively, as well as a booster effect in 100% of the cases after revaccination. The tolerability of this new, alum-free vaccine has been excellent with 6-25% local and 0-13% mild systemic reactions after a dose of 0.5 ml. Stability testing with and without detergent indicated partial internalization of the hepatitis A virions in the phospholipid bilayer of the liposome vesicles with storage. Immunization of 10 healthy adult volunteers with vaccine stored for 32 months at 4 degrees C showed, however, that the duration of storage has no influence on immunogenicity and tolerability of the vaccine.
Schweizerisches Serum- und Impfinstitut, Bern.
A
A
Wegmann
M
M
Zellmeyer
R
R
Glück
B
B
Finkel
A
A
Flückiger
R
R
Berger
M
M
Just
D000328:Adult; D000535:Aluminum; D004337:Drug Carriers; D004355:Drug Stability; D004356:Drug Storage; D005260:Female; D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D006508:Hepatitis Antibodies / Q000302:isolation & purification; D006507:Hepatovirus / Q000276:immunology*; D006801:Humans; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D014613:Vaccines, Attenuated; D014761:Viral Hepatitis Vaccines / Q000008:administration & dosage / Q000276:immunology*
D004337:Drug Carriers; D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D006508:Hepatitis Antibodies; D008081:Liposomes; D014613:Vaccines, Attenuated; D014761:Viral Hepatitis Vaccines; D000535:Aluminum
Immunogenität und Stabilität eines aluminiumfreien liposomalen Hepatitis-A-Impfstoffs (Epaxal Berna).