Journal
EXPERT REVIEW OF VACCINES
Volume 16, Issue 10, Pages 1045-1052Publisher
TAYLOR & FRANCIS LTD
DOI: 10.1080/14760584.2017.1367667
Keywords
Hepatitis B; vaccine; hemodialysis; randomized controlled trial; immunogenicity
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Funding
- National Science and Technology Major Project of the Ministry of Science and Technology of China [2012ZX10002001]
- Research Project - Shanxi Scholarship Council of China [2013-056]
- Open Project by State Key Laboratory of Infectious Disease Prevention and Control [2016SKLID311]
- Construction Project of Characteristic Key Disciplines for Universities of Shanxi Province
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Background: To evaluate the immunogenicity, antibody persistence, and safety of the 60 mu g 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 mu g (IM20 group) or 60 mu g (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 mu g recombinant hepatitis B vaccines elicited stronger immune responses than the 20 mu g hepatitis B vaccine did among hemodialysis patients.Clinical trial registration: ClinicalTrials.gov, number NCT02963714.
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