Seroprotection achieved with standard four-dose schedule of hepatitis B vaccine in people with chronic kidney disease: A real-life data.

Background and objectives: Hepatitis B virus (HBV) infection is common in people with chronic kidney diseases (CKD). The guidelines recommend four doses, 2.0 mL each, of HBV vaccine, given at zero, one, two and six months in these patients. However, real-life data on the effectiveness of this schedule are limited. We retrospectively reviewed the HBV vaccine response in the CKD population.

Methods: The study included adult (≥ 18 years) patients with glomerular filtration rate < 60 mL/min, if they had received four doses (each of 2.0 mL volume) of HBV vaccine and anti-HBs titer was measured at ≥ 1 month of the last dose of vaccine. Participants with hepatitis C or human immunodeficiency virus (HIV) coinfection, organ transplant recipients, active or remote malignancy or use of immunosuppressive medication were excluded. Anti-HBs antibody was measured with two different assays with their limits of detection up to 500 mIU/mL and 1000 mIU/mL. The presence of detectable anti-HBs antibody and anti-HBs titer ≥ 10 mIU/mL defined seroconversion and seroprotection, respectively.

Results: The study included 208 patients (71.9% males; age 44 [33-55] years; CKD stage II/III/IV/V in 1.4%/7.2%/26.4%/64.9%; 46% on maintenance hemodialysis [MHD]). Overall, seroconversion and seroprotection were achieved in 174 (83.7%) and 161 (77.4%) participants and anti-HBs titer, measured three (2-8) months after the fourth dose, was 124 (12-500) mIU/mL. The median anti-HBs antibody levels at ≤ 6, 7-12, 13-24 and 24 months after the fourth doses were 116, 478, 43 and 70 mIU/mL, respectively. Age, body mass index, stage of CKD, serum albumin and dialysis status were not associated with seroprotection (p < 0.05).

Conclusion: A standard vaccination schedule of four 2.0 mL doses of HBV vaccine in CKD patients induces reasonably good and sustained seroprotection.