Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients

Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Methadone Maintenance Treatment Patients in China: a Randomized Controlled Trial

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.

Inclusion Criteria:

• Aged between 18 and 70 years at the enrolment
• Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
• Willing to adhere to the study protocol

Exclusion Criteria:

• Being pregnant
• Intolerance or allergy to any component of the vaccine
• Any vaccination during the month preceding enrollment
• Ongoing opportunistic infection
• Liver disease
• Hematological disorder
• Cancer
• Unexplained fever the week before enrollment