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 methadone maintenance treatment patients.
Comparison of 2 vaccination strategy against Hepatitis B in patients with Methadone Maintenance Treatment Intervention: Arm 1 : 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6; Arm 2 : 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
196
three-dose, 60 µg per dose
three-dose, 20 µg per dose
Number and Rate of Participants With Anti-HBs Seroconversion at Month 7
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml.
Time frame: Month 7
Anti-HBs Concentration at Month 7
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Time frame: Month 7
Anti-HBs Concentration at Month 12
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Time frame: Month 12
Number and Rate of Participants With Anti-HBs Seroconversion at Month 12
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml
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, at Month 0, 1, and 6
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, at Month 0, 1, and 6
Anti-HBs Concentration at Month 18
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The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Time frame: Month 18
Number and Rate of Participants With Anti-HBs Seroconversion at Month 18
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml
Time frame: Month 18
Anti-HBs Concentration at Month 30
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Time frame: Month 30
Number and Rate of Participants With Anti-HBs Seroconversion at Month 30
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml
Time frame: Month 30
Anti-HBs Concentration at Month 42
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Time frame: Month 42
Number and Rate of Participants With Anti-HBs Seroconversion at Month 42
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml
Time frame: Month 42