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OpenTrials
Completed

NCT Number: NCT02959775

Immunogenicity of Hepatitis B Vaccination Among Drug Users

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

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Key information

Conditions

Hepatitis B Vaccination Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

60 µg dose hepatitis B vaccine

Biological

three-dose, 60 µg per dose

20 µg dose hepatitis B vaccine

Biological

three-dose, 20 µg per dose

Primary outcomes

  1. 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.

Secondary outcomes

  1. Anti-HBs Concentration at Month 7

    Time frame: Month 7

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）.

  2. Anti-HBs Concentration at Month 12

    Time frame: Month 12

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）.

  3. 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.

  4. 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

  5. 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

  6. Serious Adverse Events (SAE) Occurred During Month 12

    Time frame: Month 0-12

Other outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Shanxi Medical University

Other

Collaborators

  • Centers for Disease Control and Prevention, China

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 9, 2016
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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