At present, chronic kidney disease population are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal. This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1, 2, and 6 in chronic kidney disease population.
Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. 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
300
three-dose, 20 µg per dose
four-dose, 20 µg per dose
four-dose, 60 µg per dose
The Central Hospital of Linfen
Linfen, China
The People's Hospital of Linfen
Linfen, China
Anti-HBs Seroconversion Rate at Month 7
Anti-HBs Seroconversion Rate at month 7 as measured by CMIA
Time frame: Month 7
Anti-HBs concentration at month 7
Anti-HBs concentration at month 7 as measured by CMIA
Time frame: Month 7
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
Anti-HBs Seroconversion Rate at Month 12
Anti-HBs Seroconversion Rate at month 12 as measured by CMIA
Time frame: Month 12
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 18
Anti-HBs Seroconversion Rate at month 18 as measured by CMIA
Time frame: Month 18
Anti-HBs Concentration at Month 18
Anti-HBs Concentration at Month 18 as measured by CMIA
Time frame: Month 18
Anti-HBs Seroconversion Rate at Month 30
Anti-HBs Seroconversion Rate at month 30 as measured by CMIA
Time frame: Month 30
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Anti-HBs Concentration at Month 30
Anti-HBs Concentration at Month 30 as measured by CMIA
Time frame: Month 30
Anti-HBs Seroconversion Rate at Month 42
Anti-HBs Seroconversion Rate at month 42 as measured by CMIA
Time frame: Month 42
Anti-HBs Concentration at Month 42
Anti-HBs Concentration at Month 42 as measured by CMIA
Time frame: Month 42