Immunogenicity, Safety, and Persistence Induced by Triple- and Standard-Strength 4-Dose Hepatitis B Vaccination Regimens in Patients Receiving Hemodialysis.

Abstract

Patients receiving hemodialysis represent a high-risk group for hepatitis B virus (HBV) infection. It is crucial to administer hepatitis B vaccination and stimulate higher and more sustained levels of hepatitis B surface antibodies (anti -HBs). Our aim is to enhance the immunogenicity and persistence by implementing high-dose and prolonged hepatitis B vaccine schedules in patients receiving hemodialysis. We conducted this multicenter, randomized, parallel-controlled trial between July 2020 and February 2023 at 11 hospitals in Shanxi province, China. A total of 504 patients receiving hemodialysis were enrolled. All participants were randomly allocated in a ratio of 1:1:1 to receive recombinant HBV vaccine of 3 standard doses (20 μg) at 0, 1, and 6 months (IM20 × 3 group), 4 standard doses at 0, 1, 2, and 6 months (IM20 × 4 group), or 4 triple doses (60 μg) at 0, 1, 2, and 6 months (IM60 × 4 group). The vaccine-elicited antibody response peaked at month 7. The follow-up from month 7 to 30 revealed that response rates of anti-HBs decreased from 85.9% (134/156) to 33.0% (33/100) in IM20 × 3 group, from 92.5% (135/146) to 53.9% (56/104) in IM20 × 4 group, and from 95.4% (145/152) to 57.3% (55/96) in IM60 × 4 group. The duration of vaccine-induced response with 75% of patients maintained protective antibodies were 21.0 months in IM20 × 3 group, 25.7 months in IM20 × 4 group (vs IM20 × 3 group, P = .056), and 29.2 months in IM60 × 4 group (vs IM20 × 3 group, P = .034). All the adverse reactions were mild. The triple-strength 4-dose hepatitis B vaccination regimens could enhance the immunogenicity and 2-year duration in patients receiving hemodialysis.Clinical Trials Registration. NCT03962881.