Immunogenicity and Persistence of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients

Shanxi Medical University

Status and phase: Unknown; Phase 4

Conditions: Hepatitis B Vaccine

Treatments: Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6; Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6; Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6

Study type: Interventional

Funder types: Other

Identifiers

NCT03962816

2018ZX10721202001002002

Details and patient eligibility

About

At present, Methadone Maintenance Treatment Patients of Hepatitis B Vaccination in are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.

This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in Methadone Maintenance Treatment Patients

Full description

Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.

Enrollment: 300 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment
• Sign informed consent, willing to participate in this study

Exclusion criteria

• Being pregnant
• Intolerance or allergy to any component of the vaccine
• Any vaccination during the month preceding enrollment
• Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
• Patient with HIV Infection
• The use of immunosuppressive agents in patients with nearly three months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

300 participants in 3 patient groups

20 µg at months 0, 1, and 6

Experimental group

Description:

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

Treatment:

Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6

20 µg at months 0, 1, 2,and 6

Experimental group

Description:

20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6

Treatment:

Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6

60 µg at months 0, 1, 2,and 6

Experimental group

Description:

60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6

Treatment:

Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6