Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients

Shanxi Medical University

Status and phase: Completed; Phase 4

Conditions: Hepatitis B Vaccine

Treatments: Biological: 60 µg dose hepatitis B vaccine; Biological: 20 µg dose hepatitis B vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02991599

2012ZX10002001003004003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 196 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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196 participants in 2 patient groups

60 µg dose hepatitis B vaccine

Experimental group

Description:

60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6

Treatment:

Biological: 60 µg dose hepatitis B vaccine

20 µg dose hepatitis B vaccine

Experimental group

Description:

20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6

Treatment:

Biological: 20 µg dose hepatitis B vaccine