title: Long-term immunogenicity of preservative-free hepatitis B vaccine formulations in adults.
abstract: Vaccination with recombinant hepatitis B vaccines is highly effective in preventing hepatitis B infection. Recently, a preservative-free (PF) formulation of hepatitis B vaccine [GlaxoSmithKline (GSK) Biologicals, Rixensart, Belgium] has been licensed. The immunogenicity of the PF hepatitis B vaccine and antibody persistence 6 years later was assessed in this study. This formulation was compared with the preservative- containing (PC) formulation of the vaccine and a low-preservative (LP) content formulation. Five hundred forty-one healthy adult subjects were evaluated in the primary study. Over 94% of the subjects in the three study groups had seroprotective anti-HBs antibody concentrations (>or=10 mIU/ml) 1 month after completing primary vaccination. Antibody measurements in 242 healthy adults who returned for the follow-up study and who had received primary vaccination 6 years earlier showed that over 81% of subjects in the three study groups still had anti-HBs antibody concentrations >or=10 mIU/ml. No apparent differences in antibody decline or distribution between the study groups were observed. These results indicate that the removal of preservatives from the hepatitis B vaccine does not affect adversely its immunogenicity both in the short and in the longer term.
authors.affiliation: Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Wilrijk, Belgium.
authors.forename: Pierre
authors.initials: P
authors.lastname: Van Damme
authors.forename: Frank
authors.initials: F
authors.lastname: von Sonnenburg
authors.forename: Christoph
authors.initials: C
authors.lastname: Hatz
authors.forename: Bernard
authors.initials: B
authors.lastname: Hoet
authors.forename: Inge
authors.initials: I
authors.lastname: Lefevre
authors.forename: Maarten
authors.initials: M
authors.lastname: Leyssen
mesh_terms: D000293:Adolescent; D000328:Adult; D001530:Belgium; D004355:Drug Stability; D005260:Female; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011310:Preservatives, Pharmaceutical / Q000494:pharmacology*; D055815:Young Adult
chemical_list: D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D011310:Preservatives, Pharmaceutical