Incidence and Predictors of Hepatitis B Vaccine Non-Response among Hemodialysis Patients

Purpose:  Tremendous strides have been made to protect hemodialysis (HD) patients from bloodborne pathogen infections, including hepatitis B virus (HBV) vaccination. Despite routine immunization against HBV in the HD population, antibody response is often variable and inadequate. The objectives of this study were to quantify the incidence and identify risk factors of HBV vaccine non-response among maintenance HD patients.

Methods:  A retrospective cohort study was conducted at Rubin Dialysis Centers between January and June 2011. Inclusion criteria were: age ≥ 18 years, uninfected with HBV, received ≥ 1 HBV vaccine dose (Recombivax HB®) as a HD patient and availability of hepatitis B surface antibody (anti-HBs) titers to classify outcome status. Vaccine non-response was defined as an anti-HBs titer < 10 mIU/mL. Due to the high proportion (>10%) of patients with titers < 10 mIU/mL, log-Poisson regression was used to determine factors independently associated with vaccine non-response.

Results:  During the study period 119 patients (51% female, 85% Caucasian, 40% diabetic etiology) were identified.  At the time of 1^st vaccine dose, mean±SD age was 62.9±15.5 years and median (IQR) HD vintage was 13.1 (3.1-34.4) months. Overall, 50% of patients failed to achieve anti-HBs titers ≥ 10 mIU/mL after receiving the primary vaccine series. Of primary series non-responders, 17 patients received subsequent doses and only 24% (n=4) achieved titers ≥ 10 mIU/mL. In multivariate analyses, age ≥ 58 years (RR[95% CI]=1.65[1.08,2.51];  p=0.02), BMI ≥ 36.4 kg/m² (RR[95% CI]=1.81[1.08,2.51]; p<0.01) and receiving ≥ 4 vaccine doses (RR[95% CI]=1.64[1.22,2.21]; p<0.01) were independently associated with HBV vaccine non-response.

Conclusion:  Older age and obesity appear to be important predictors of HBV vaccine non-response among HD patients. Attainment of protective anti-HBs titers after primary HBV vaccine series and supplemental doses was suboptimal, suggesting current HBV immunization strategies in the HD population may be ineffective and warrants further investigation.