Immunogenicity of Hepatitis B Vaccination Among Drug Users

December 3, 2021 updated by: Suping Wang, Shanxi Medical University

Immunogenicity and Safety of High-dose Hepatitis B Vaccine Among Drug Users: a Randomized, Controlled Trial

Uptake, adherence, and completion of vaccination among drug users were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect drug users from HBV infection.

This is a randomized, open-label, blank-controlled trial, conducted among drug users with drug rehabilitation. This study will compare the immunogenicity and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug users

Study Overview

Detailed Description

Comparison of 2 vaccination strategy against Hepatitis B in Drug Users

Intervention:

Arm 1 : Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6;

Arm 2 : Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6;

Arm 3 : Receive no vaccination during the study period.

Study Type

Interventional

Enrollment (Actual)

480

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

Male

Description

Inclusion Criteria:

  • Aged between 18 and 70 years at the enrolment
  • current illicit drug users before drug rehabilitation
  • negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
  • having spent acute physiological detoxification phase

Exclusion Criteria:

  • any intolerance or allergy to any component of the vaccine
  • ongoing opportunistic infection
  • liver disease
  • hemopathy
  • cancer
  • unexplained fever in the last week before the recruiting

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 60 µg dose hepatitis B vaccine
Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6
three-dose, 60 µg per dose
Experimental: 20 µg dose hepatitis B vaccine
Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6
three-dose, 20 µg per dose
No Intervention: Control
Receive no vaccination during the study period

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 12
Time Frame: Month 12
The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay).
Month 12
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
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
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
Within 28 days after the vaccination, at Month 0, 1, and 6
Serious Adverse Events (SAE) Occurred During Month 12
Time Frame: Month 0-12
Month 0-12

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
Anti-HBs Concentration at Month 6 Before the Third Injection
Time Frame: Month 6 before the third injection
Anti-HBs concentration at month 6 before the third injection by CMIA
Month 6 before the third injection
Number and Rate of Participants With Anti-HBs Seroconversion at Month 6 Before the Third Injection
Time Frame: Month 6 before the third injection
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. The accepted protective serum anti-HBs level was ≥10 mIU/ml.
Month 6 before the third injection
Number and Rate of Participants With Anti-HBs High-level Response at Month 6 Before the Third Injection
Time Frame: Month 6 before the third injection
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.
Month 6 before the third injection

Collaborators and Investigators

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

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.

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 (Actual)

August 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

November 7, 2016

First Posted (Estimate)

November 9, 2016

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

December 3, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

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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