Immunogenicity of Hepatitis B Vaccination Among Drug Users
- Conditions
- Hepatitis B Vaccination
- Interventions
- Biological: 20 µg dose hepatitis B vaccineBiological: 60 µg dose hepatitis B vaccine
- Registration Number
- NCT02959775
- Lead Sponsor
- Shanxi Medical University
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 480
- Aged between 18 and 70 years at the enrolment
- current illicit drug users before drug rehabilitation
- negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
- having spent acute physiological detoxification phase
- any intolerance or allergy to any component of the vaccine
- ongoing opportunistic infection
- liver disease
- hemopathy
- cancer
- unexplained fever in the last week before the recruiting
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 20 µg dose hepatitis B vaccine 20 µg dose hepatitis B vaccine Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6 60 µg dose hepatitis B vaccine 60 µg dose hepatitis B vaccine Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6
- Primary Outcome Measures
Name Time Method Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 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.
- Secondary Outcome Measures
Name Time Method Number and Rate of Participants With Anti-HBs Seroconversion at Month 12 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.Anti-HBs Concentration at Month 7 Month 7 The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）.
Occurrence of Adverse Events After Vaccination Within 28 days after the vaccination, at Month 0, 1, and 6 Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B
Anti-HBs Concentration at Month 12 Month 12 The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）.
Serious Adverse Events (SAE) Occurred During Month 12 Month 0-12