Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients

Phase 4

Completed

• Conditions: Hepatitis B Vaccine
• Interventions: Biological: 60 µg dose hepatitis B vaccine; Biological: 20 µg dose hepatitis B vaccine

• Registration Number: NCT02991599
• Lead Sponsor: Shanxi Medical University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-07
• Study First Submitted: 2016-12-10
• Study First Submitted QC: 2016-12-10
• Study First Posted: 2016-12-13
• Study Completion: 2018-05
• Results First Submitted: 2019-05-23
• Results First Submitted QC: 2019-05-23
• Results First Posted: 2019-07-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-26
• Last Update Posted: 2021-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
60 µg dose hepatitis B vaccine	60 µg dose hepatitis B vaccine	60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
20 µg dose hepatitis B vaccine	20 µg dose hepatitis B vaccine	20 µg recombinant hepatitis B vaccine with three injections 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
Anti-HBs Concentration at Month 12	Month 12	The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
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 18	Month 18	The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Number and Rate of Participants With Anti-HBs Seroconversion at Month 18	Month 18	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
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 vaccine
Anti-HBs Concentration at Month 42	Month 42	The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Anti-HBs Concentration at Month 7	Month 7	The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Anti-HBs Concentration at Month 30	Month 30	The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Number and Rate of Participants With Anti-HBs Seroconversion at Month 42	Month 42	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
Number and Rate of Participants With Anti-HBs Seroconversion at Month 30	Month 30	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