BACKGROUND: To evaluate the immunogenicity, antibody persistence, and safety of the 60 µg hepatitis B vaccine in hemodialysis patients in China. METHODS: We conducted a multicenter, randomized, double-blind, parallel-controlled trial including 352 hemodialysis patients who were centrally randomized in a ratio of 1:1 to receive a20 µg (IM20 group) or 60 µg (IM60 group) recombinant hepatitis B vaccine at months 0, 1, and 6. RESULTS: The vaccine-elicited antibody responses peaked at month 7, and declined at month 12. At month 7, the IM60 group had stronger GMC of anti-HBs, and a higher proportion of seroconversion and high-level response than the IM20 group did (P < 0.05). Better immune responses were observed in the IM60 group, especially for those aged or in the high-frequency hemodialysis population. CONCLUSION: The high dose 60 µg recombinant hepatitis B vaccines elicited stronger immune responses than the 20 µg hepatitis B vaccine did among hemodialysis patients. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, number NCT02963714.
RCT Entities:
BACKGROUND: To evaluate the immunogenicity, antibody persistence, and safety of the 60 µg hepatitis B vaccine in hemodialysis patients in China. METHODS: We conducted a multicenter, randomized, double-blind, parallel-controlled trial including 352 hemodialysis patients who were centrally randomized in a ratio of 1:1 to receive a 20 µg (IM20 group) or 60 µg (IM60 group) recombinant hepatitis B vaccine at months 0, 1, and 6. RESULTS: The vaccine-elicited antibody responses peaked at month 7, and declined at month 12. At month 7, the IM60 group had stronger GMC of anti-HBs, and a higher proportion of seroconversion and high-level response than the IM20 group did (P < 0.05). Better immune responses were observed in the IM60 group, especially for those aged or in the high-frequency hemodialysis population. CONCLUSION: The high dose 60 µg recombinant hepatitis B vaccines elicited stronger immune responses than the 20 µg hepatitis B vaccine did among hemodialysis patients. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, number NCT02963714.