Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates are inadequate and persistence of immunity remains a challenge. This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in hemodialysis patients.
Participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis B vaccine group or 60µg recombinant hepatitis B vaccine group.The 20 µg group will receive three intramuscular injections of the 20 µg recombinant hepatitis B vaccine, while the 60 µg group will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6, respectively. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
352
three-dose, 60 µg per dose
three-dose, 20 µg per dose
Anti-HBs Seroconversion Rate at Month 7
Time frame: Month 7
Anti-HBs Seroconversion Rate at Month 42
Time frame: Month 42
Anti-HBs Seroconversion Rate at Month 36
Time frame: Month 36
Anti-HBs Seroconversion Rate at Month 30
Time frame: Month 30
Anti-HBs Seroconversion Rate at Month 24
Time frame: Month 24
Anti-HBs Concentration at Month 7
Anti-HBs concentration at month 7 as measured by CMIA
Time frame: Month 7
Anti-HBs Concentration at Month 12
Anti-HBs concentration at month 12 as measured by CMIA
Time frame: Month 12
Anti-HBs Seroconversion Rate at Month 12
Time frame: Month 12
Occurrence of Adverse Events After Vaccination
Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine
Time frame: Within 7 days after the vaccination
Occurrence of Adverse Events After Vaccination
Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine
Time frame: Within 28 days after the vaccination
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Anti-HBs Seroconversion Rate at Month 18
Time frame: Month 18