Antibody Response to Hepatitis B Vaccine in End-Stage Renal Disease Patients

Abstract

Background: 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. Methods: 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 ≧10 mIU/l. Dose efficacy was further evaluated by comparing three historical cohorts vaccinated by the regimens of 20, 40 and 80 µg/dose, respectively. Results: 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 µg 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 µg of Engerix-B increased the likelihood of persistent protective antibody (log-rank test, p = 0.014). Immunization with Engerix-B 80-µg 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)). Conclusions: Our results suggest the potential for the three-dose schedule of recombinant vaccine Engerix-B 80 µg to prolong the immune response among ESRD population.

Efficacy and Safety of Reinforced Versus Standard Vaccine Schedule Towards Hepatitis B In Chronic Kidney Disease: A Systematic Review and Meta-Analysis

“…Two hepatitis B infections occurred over the follow-up in 1 trial (21), no SAEs were observed in the others (23)(24)(25)(29)(30)(31). No dropouts due to side effects were reported.…”

“…A total of 11 studies met the inclusion criteria (21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31). A complete list of the 431 reports reviewed is available (see supplementary File 2).…”

“…The mean age of subject cohorts ranged from 39.9 ± 14 to 66 (30 -81) years, and the rate of males was 66%. A minority of patients (n = 141) had chronic kidney disease at the pre-dialysis stage (24,29); patients on peritoneal dialysis (n = 139) were included in only 2 studies (30,31). Three studies employed plasma-derived vaccines; 8 studies recombinant vaccines, Engerix-B, Glaxo-Smith Kline (n = 6), and Recombivax, MSD (n = 1).…”

“…Information on adverse events was given in 6 studies (23)(24)(25)(29)(30)(31). Two hepatitis B infections occurred over the follow-up in 1 trial (21), no SAEs were observed in the others (23)(24)(25)(29)(30)(31).…”

Sex bias in response to hepatitis B vaccination in end-stage renal disease patients: Meta-analysis

“…After excluding studies not fulfilling inclusion criteria, 19 clinical trials [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25] have been remained whose demoKhedmat H et al . Sex and HBV vaccine immunogenicity graphic data is summarized in Table 1.…”