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      Improved Immunogenicity of a Novel Third-Generation Recombinant Hepatitis B Vaccine in Patients with End-Stage Renal Disease

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          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<sup>®</sup>, 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 µg of Bio-Hep-B<sup>®</sup> 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 ≧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<sup>®</sup> 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.

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          Most cited references 5

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          Improved immunogenicity in mice of a mammalian cell-derived recombinant hepatitis B vaccine containing pre-S1 and pre-S2 antigens as compared with conventional yeast-derived vaccines.

           D Shouval,  Y Ilan,  R. Adler (1994)
          The widely used hepatitis B virus (HBV) vaccines consist of the small hepatitis B surface (SHBs) protein produced in transfected yeast cells. The frequency of non-responders, especially among immunocompromised patients, has increased the demand for a more immunogenic vaccine. We evaluated the immunogenicity of recombinant HBs 20 nm particles secreted by transfected Chinese hamster ovary (CHO) cells, Bio-Hep-B (BioTechnology General Ltd, Israel), and compared it with yeast-derived vaccines. The CHO-derived vaccine contains the small hepatitis B surface antigen (SHBs protein) as the major component, as well as the middle HBs (MHBs, pre-S2) and the large HBs (LHBs, pre-S1) antigens. Nine groups of ten female Balb/c mice, 4-6 weeks old, were injected once intraperitoneally (i.p.) with 0.09, 0.27 or 0.81 micrograms of each of three vaccines: Bio-Hep-B or two conventional yeast-derived recombinant vaccines, Engerix-B (SmithKline Beecham, Belgium) and H-B-Vax II (Merck, Sharp & Dohme, USA) containing only non-glycosylated SHBs antigen. After 30 days, 40% of the mice injected with 0.09 microgram Bio-Hep-B had seroconverted, but none of the mice receiving the same dose of the other vaccines. The immunogenic dose in 50% of the mice at day 14 after injection was 0.13 microgram for Bio-Hep-B, but over 0.81 microgram for the other two vaccines. Mice of the strain B10/M (which are unresponsive to SHBs and MHBs antigens at the T-cell level) developed 100-fold higher anti-HBs titres after immunization with 1 microgram of Bio-Hep-B i.p., as compared with mice receiving the same amount of yeast-derived HBsAg vaccines.(ABSTRACT TRUNCATED AT 250 WORDS)
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            Duration of hepatitis B surface antigenemia (HBs Ag) in hemodialysis patients.

            Follow-up studies were done on 231 hemodialysis patients during a period of from one to 48 months to determine the natural history of hepatitis B surface antigenemia (HBs Ag). Of those studied, 113 (49%) exhibited HBs Ag. The probability of remaining HBs Ag positive over the mean follow-up period of 14.4 months was 62%. All of the 38 patients whose HBs Ag reverted to negative did so within ten months. Those patients whose HBs Ag reverted to negative had SGOT levels that were less frequently elevated than the patients with persistent antigenemia. Of hemodialysis patients with HBs Ag, 60% showed e antigen (HBe Ag).
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              Vaccine Recommendations for Patients on Chronic Dialysis


                Author and article information

                Nephron Clin Pract
                Nephron Clinical Practice
                S. Karger AG
                June 2004
                17 November 2004
                : 97
                : 2
                : c67-c72
                aDepartment of Nephrology, Rabin Medical Center-Campus Golda, Petach-Tikva and Sackler Medical School, Tel-Aviv, bEpidemiology Unit, Wolfson Hospital, Holon, cGastroenterology Unit, Rabin Medical Center-Campus Golda, Petach-Tikva, Israel
                78403 Nephron Clin Pract 2004;97:c67–c72
                © 2004 S. Karger AG, Basel

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                Page count
                Tables: 2, References: 29, Pages: 1
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                Original Paper

                Cardiovascular Medicine, Nephrology

                HBV, Dialysis, Vaccine, Immunogenicity


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