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Immunogenicity of Hepatitis B Vaccination Among Drug Users

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ClinicalTrials.gov Identifier: NCT02959775
Recruitment Status : Unknown
Verified November 2016 by Suping Wang, Shanxi Medical University.
Recruitment status was:  Active, not recruiting
First Posted : November 9, 2016
Last Update Posted : November 9, 2016
Sponsor:
Collaborator:
Centers for Disease Control and Prevention, China
Information provided by (Responsible Party):
Suping Wang, Shanxi Medical University

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Hepatitis B Vaccination Biological: 60 µg dose hepatitis B vaccine Biological: 20 µg dose hepatitis B vaccine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of High-dose Hepatitis B Vaccine Among Drug Users: a Randomized, Controlled Trial
Study Start Date : August 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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
Biological: 60 µg dose hepatitis B vaccine
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
Biological: 20 µg dose hepatitis B vaccine
three-dose, 20 µg per dose

No Intervention: Control
Receive no vaccination during the study period



Primary Outcome Measures :
  1. Anti-HBs seroconversion rate at month 7 [ Time Frame: Month 7 ]
    Anti-HBs seroconversion rate at month 7


Secondary Outcome Measures :
  1. Anti-HBs concentration at month 7 [ Time Frame: Month 7 ]
    Anti-HBs concentration at month 7 as measured by CMIA

  2. Anti-HBs concentration at month 12 [ Time Frame: Month 12 ]
    Anti-HBs concentration at month 12 as measured by CMIA

  3. Anti-HBs seroconversion rate at month 12 [ Time Frame: Month 12 ]
    Anti-HBs seroconversion rate at month 12

  4. Occurrence of adverse events after vaccination [ Time Frame: Within 7 days after the vaccination ]
    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 ]
    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 ]
    Serious adverse events (SAE) occurred during month 12


Other Outcome Measures:
  1. High-level response rate at month 7 [ Time Frame: Month 7 ]
    High-level response rate at month 7

  2. High-level response rate at month 12 [ Time Frame: Month 12 ]
    High-level response rate at month 12

  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. Anti-HBs seroconversion rate at month 6 before the third injection [ Time Frame: Month 6 before the third injection ]
    Anti-HBs seroconversion rate at month 6 before the third injection

  5. High-level response rate at month 6 before the third injection [ Time Frame: Month 6 before the third injection ]
    High-level response rate at month 6 before the third injection



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959775


Sponsors and Collaborators
Shanxi Medical University
Centers for Disease Control and Prevention, China
Investigators
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Principal Investigator: Suping Wang Shanxi Medical University

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Responsible Party: Suping Wang, Professor, Shanxi Medical University
ClinicalTrials.gov Identifier: NCT02959775     History of Changes
Other Study ID Numbers: 2012ZX10002001003004002
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Suping Wang, Shanxi Medical University:
Hepatitis B vaccination
Immunogenicity
Randomized controlled trial
Drug abuse
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs