Long-term persistent immunogenicity after successful standard and triple-dosed hepatitis B vaccine in hemodialysis patients: A 3-year follow-up study in China.

Abstract

BACKGROUND\nAlthough the efficacy of hepatitis B vaccines among hemodialysis patients has been documented, the long-term persistence of immunogenicity in this population remains largely unknown. We explored the long-term persistence of immunogenicity induced by different hepatitis B vaccine regimens in hemodialysis patients.\n\n\nMETHODS\nIn initial study, we conducted a randomized, multicenter, double-blind, parallel-controlled trial among hemodialysis patients in 13 hospitals in Shanxi Province, China. A total of 352 hemodialysis patients were allocated to receive 3-dose 20\xa0μg (IM20 group) and 3-dose 60\xa0μg (IM60 group) recombinant hepatitis B vaccine at months 0, 1, and 6. Vaccine-induced immune responses were measured at month 7. In this study, the responders (anti-HBs\xa0≥\xa010 mIU/mL) were followed up at months 18, 24, 30, 36 and 42, respectively. We used the generalized log-rank test and generalized estimating equations (GEE) to analyze the long-term durability of responses and the kinetics of anti-HBs levels, respectively.\n\n\nRESULTS\nA total of 284 patients were involved in the extended follow-up period. The duration of vaccine-induced response with 75% of patients maintained protective antibody were 12\xa0months and 18\xa0months in the IM20 group and IM60 group, respectively (P\xa0=\xa00.291). The long-term persistent immunogenicity induced by 3-dose 60\xa0μg was more satisfactory than that by 3-dose 20\xa0μg hepatitis B vaccine in patients with hemodialysis duration\xa0≥\xa0five years (P\xa0=\xa00.023). The peak anti-HBs levels in 100-1000 mIU/mL or\xa0≥\xa01000 mIU/mL were more likely to maintain long-term protective antibody compared to anti-HBs levels in 10-100 mIU/mL (P ＜ 0.05). The kinetic profile was similar between the two groups (P\xa0=\xa00.334).\n\n\nCONCLUSION\nHigh-dose 60\xa0μg hepatitis B vaccine could lead a satisfactory long-term durability of immunogenicity among patients with hemodialysis duration of five years or more. Peak anti-HBs level after vaccination was associated with the long-term persistence of immunogenicity.