Immunogenicity, antibody persistence, and safety of the 60 μg hepatitis B vaccine in hemodialysis patients: a multicenter, randomized, double-blind, parallel-controlled trial

ABSTRACT

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.

KEYWORDS:

• Hepatitis B
• vaccine
• hemodialysis
• randomized controlled trial
• immunogenicity

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

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Additional information

Funding

The study was funded by the National Science and Technology Major Project of the Ministry of Science and Technology of China (2012ZX10002001), Research Project Supported by Shanxi Scholarship Council of China (2013-056), Open Project Supported by State Key Laboratory of Infectious Disease Prevention and Control (2016SKLID311), and Construction Project of Characteristic Key Disciplines for Universities of Shanxi Province.