Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients

November 26, 2021 updated by: Suping Wang, Shanxi Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

196

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 60 µg dose hepatitis B vaccine
60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
Biological: 60 µg dose hepatitis B vaccine
three-dose, 60 µg per dose
Experimental: 20 µg dose hepatitis B vaccine
20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
Biological: 20 µg dose hepatitis B vaccine
three-dose, 20 µg per dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Rate of Participants With Anti-HBs Seroconversion at Month 7
Time Frame: 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.
Month 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-HBs Concentration at Month 7
Time Frame: Month 7
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Month 7
Anti-HBs Concentration at Month 12
Time Frame: Month 12
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Month 12
Number and Rate of Participants With Anti-HBs Seroconversion at Month 12
Time Frame: 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
Month 12
Occurrence of Adverse Events After Vaccination
Time Frame: Within 7 days after the vaccination, at Month 0, 1, and 6
Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine
Within 7 days after the vaccination, at Month 0, 1, and 6
Occurrence of Adverse Events After Vaccination
Time Frame: 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
Within 28 days after the vaccination, at Month 0, 1, and 6
Anti-HBs Concentration at Month 18
Time Frame: Month 18
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Month 18
Number and Rate of Participants With Anti-HBs Seroconversion at Month 18
Time Frame: 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
Month 18
Anti-HBs Concentration at Month 30
Time Frame: Month 30
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Month 30
Number and Rate of Participants With Anti-HBs Seroconversion at Month 30
Time Frame: 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
Month 30
Anti-HBs Concentration at Month 42
Time Frame: Month 42
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
Month 42
Number and Rate of Participants With Anti-HBs Seroconversion at Month 42
Time Frame: 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
Month 42

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Rate of Participants With Anti-HBs High-level Response at Month 7
Time Frame: Month 7
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.
Month 7
Number and Rate of Participants With Anti-HBs High-level Response at Month 12
Time Frame: Month 12
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
Month 12
Number and Rate of Participants With Anti-HBs High-level Response at Month 18
Time Frame: Month 18
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
Month 18
Number and Rate of Participants With Anti-HBs High-level Response at Month 30
Time Frame: Month 30
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
Month 30
Number and Rate of Participants With Anti-HBs High-level Response at Month 42
Time Frame: Month 42
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
Month 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanxi Medical University

Collaborators

Centers for Disease Control and Prevention, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

December 10, 2016

First Submitted That Met QC Criteria

December 10, 2016

First Posted (Estimate)

December 13, 2016

Study Record Updates

Last Update Posted (Actual)

December 23, 2021

Last Update Submitted That Met QC Criteria

November 26, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012ZX10002001003004003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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