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 µg 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 ≧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.

Recombinant Hepatitis B Vaccine Adjuvanted With AS04 in Dialysis Patients: A Prospective Cohort Study

“…Despite their extraordinary efficacy second-generation HB vaccines can result in immunization failure which can be explained by numerous variables including renal failure and immuno-suppression. Various options are currently available to address immunization failure in patients with end-stage renal disease; second-generation recombinant vaccines formulated with adjuvants [12,13,16], or manufactured by a modified process [17] or third-generation HB vaccines [18] look promising.…”

Reduced Capacity of Mononuclear Cells to Synthesize Cytokines against an Inflammatory Stimulus in Uremic Patients

“…The antibody response to hepatitis B vaccination and skin testing for tuberculosis with tuberculin-purified protein derivative (PPD) have been used as sensitive markers for the extent of individual immune incompetence. Hyporesponsiveness to these tests is confirmed in uremic patients suggesting impairment of both cellular and humoral immunity [18, 19]. However, the mechanisms underlying these clinical phenomena are unclear.…”

Impfungen bei Immundefekten/Immunsuppression – Expertenstatement und Empfehlungen

“…Stadium der Erkrankung, männliches Geschlecht und höheres Lebensalter oder Diabetes mellitus tragen zusätzlich zur schlechten Immunantwort auf die Hepatitis-B-Impfung bei, zielgerichtete Erfassung solcher Patienten im frühen Erkrankungsstadium hingegen trägt maßgeblich zum Impferfolg bei, ebenso wie die Verwendung von Impfstoffen mit höherer Antigenkonzentration (HBVax-Pro ® 40μg oder doppelte Dosis Engerix B ® ) [38,39]. Drittgenerationsimpfstoffe (Pre-S1/S2 und S-Protein) sind trotz vielversprechender klinischer Studien [40] nach wie vor nicht erhältlich, alternative Verabreichungsformen (intradermale Injektion) bieten hingegen nur geringen Zusatznutzen [33].…”