title: Improved immunogenicity of a novel third-generation recombinant hepatitis B vaccine in patients with end-stage renal disease.
abstract: Hepatitis B (HBV) infection remains a significant epidemiological problem in the end-stage renal disease (ESRD) population. Vaccination programs using second-generation vaccines lead to effective seroprotection in only 50-60% of these patients. The purpose of this case series was to describe our experience with a novel third-generation vaccine, Bio-Hep-B, in ESRD patients who had not developed protective anti-HBs titers following a second-generation HBV vaccination protocol. Twenty-nine ESRD patients who had not responded in the past to a standard second-generation HBV vaccination protocol were included in this series. Each patient received 10 microg of Bio-Hep-B) intramuscularly at 0, 1 and 6 months. A month after completion of the vaccination protocol, anti-HBs antibody levels were measured. Following immunization, 25 of 29 patients (86%) developed seroprotective anti-HBs levels > or =10 mIU/ml. There was a significant difference in the titers of anti-HBs antibodies prior to and following vaccination (p < 0.0001). Statistical analysis of the variables age, gender, diagnosis, dialysis mode, weight, hemoglobin, albumin, and KT/V failed to detect predictors of antibody response. A retrospective analysis of the results of a second-generation vaccination program for the years 1999-2001 in our department showed that 19 of 36 (56.4%) ESRD patients developed seroprotection. In conclusion, the results of this study show that the third-generation HBV vaccine Bio-Hep-B is highly immunogenic in the population of ESRD patients who did not respond in the past to a second-generation vaccine. This enhanced seroprotection offers hope that the new vaccine will reduce the rate of non-responders and help to eliminate HBV infection from dialysis centers.
authors.affiliation: Department of Nephrology, Rabin Medical Center-Campus Golda, Petach-Tikva, Israel.
authors.forename: Talia
authors.initials: T
authors.lastname: Weinstein
authors.forename: Avry
authors.initials: A
authors.lastname: Chagnac
authors.forename: Mona
authors.initials: M
authors.lastname: Boaz
authors.forename: Yaacov
authors.initials: Y
authors.lastname: Ori
authors.forename: Michal
authors.initials: M
authors.lastname: Herman
authors.forename: Dina
authors.initials: D
authors.lastname: Zevin
authors.forename: Hemda
authors.initials: H
authors.lastname: Schmilovitz-Weiss
authors.forename: Uzi
authors.initials: U
authors.lastname: Gafter
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000276:immunology*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000276:immunology*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies
chemical_list: D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines