Immunogenicity and safety of a high-dose and prolonged-schedule hepatitis B vaccine among chronic kidney disease patients: a randomized, parallel-controlled trial

Abstract

ABSTRACT Background: The immunogenicity against hepatitis B vaccine is unsatisfactory in the chronic kidney disease (CKD) patients, and studies evaluating augmented vaccine regimens to enhance immunogenicity have been inconclusive. Objectives: To evaluate the immunogenicity and safety of four-standard-dose and four-triple-dose regimens hepatitis B vaccine among CKD patients in China. Research design and methods: We conducted a multicenter, randomized, parallel-controlled trial including 273 patients with CKD who were randomly allocated to receive 3 or 4 doses of 20 or 60 µg of recombinant hepatitis B vaccine. Main outcome measures: Seroconversion rates, high-level response rates, and geometric mean concentrations (GMCs) of anti-HBs at months 3 and 7. Results: The seroconversion rates and high-level responses in the IM20 × 4 group and the IM60 × 4 group were higher than those in the IM20 × 3 group at months 3 and 7 (P < 0.05). The IM60 × 4 group had better immune responses than the IM20 × 4 group at month 3 (P < 0.05); however, no significant difference was noted at month 7 (P > 0.05). Conclusions: Both the four-standard-dose and four-triple-dose regimens improved immune response compared to the three-standard-dose regimen of hepatitis B vaccination in CKD patients, and the additional effect of higher dose was minimal. Trial registration: The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT03962881).