Antibody response to hepatitis B vaccine in end-stage renal disease patients

This retrospective and comparative study evaluated the relationship between different factors which may contribute to suboptimal immunological response to intramuscular recombinant hepatitis B vaccine in end-stage renal disease (ESRD) subjects.

From a cohort of 64 dialysis subjects undergoing primary vaccination with Engerix-B, we determined the predictive factors that impinged on patients' response to vaccine, as defined by anti-HBs level > or = 10 mIU/l. Dose efficacy was further evaluated by comparing three historical cohorts vaccinated by the regimens of 20, 40 and 80 microg/dose, respectively.

We identified 64 ESRD patients (mean age 43 +/- 12 years, 81% receiving peritoneal dialysis) who received primary vaccination from April 1997 to September 2004. Median follow-up was 6.5 years. They achieved 81% seroconversion rate. Older age, diabetes mellitus, obesity and low Engerix-B dose were risk factors of inadequate anti-HBs response by univariate analysis. By stepwise logistic regression analysis, hepatitis B vaccine dose was the only independent predictive factor of impaired antibody response. An Engerix-B vaccine dose of 20 microg was associated with more than tenfold increase in risk of non-response to hepatitis B vaccine (hazards ratio 32.2 (95% CI 3.85-250.0)). Immunization with 80 microg of Engerix-B increased the likelihood of persistent protective antibody (log-rank test, p = 0.014). Immunization with Engerix-B 80-microg dose is estimated to prevent one extra ESRD subject who would lose seroprotective anti-HBs level at 1 year for every 5.6 patients treated (number needed to treat to benefit, 5.6 (95% CI 5.4-5.8)).

Our results suggest the potential for the three-dose schedule of recombinant vaccine Engerix-B 80 microg to prolong the immune response among ESRD population.