Uptake, adherence, and completion of vaccination among drug users were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect drug users from HBV infection. This is a randomized, open-label, blank-controlled trial, conducted among drug users with drug rehabilitation. This study will compare the immunogenicity and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug users
Comparison of 2 vaccination strategy against Hepatitis B in Drug Users Intervention: Arm 1 : Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6; Arm 2 : Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6; Arm 3 : Receive no vaccination during the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
480
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
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
Time frame: Within 28 days after the vaccination, at Month 0, 1, and 6
Serious Adverse Events (SAE) Occurred During Month 12
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Time frame: Month 0-12