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Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991599
Recruitment Status : Active, not recruiting
First Posted : December 13, 2016
Results First Posted : July 30, 2019
Last Update Posted : December 16, 2019
Sponsor:
Collaborator:
Centers for Disease Control and Prevention, China
Information provided by (Responsible Party):
Suping Wang, 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Methadone Maintenance Treatment Patients in China: a Randomized Controlled Trial
Study Start Date : October 2014
Actual Primary Completion Date : July 2015
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Methadone

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 vaccine

  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 vaccine


Other Outcome Measures:
  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.



Information from the National Library of Medicine

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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
  • 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

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): NCT02991599


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
Publications of Results:
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Responsible Party: Suping Wang, Professor, Shanxi Medical University
ClinicalTrials.gov Identifier: NCT02991599    
Other Study ID Numbers: 2012ZX10002001003004003
First Posted: December 13, 2016    Key Record Dates
Results First Posted: July 30, 2019
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suping Wang, Shanxi Medical University:
Hepatitis B, Vaccine
Immunogenicity
methadone maintenance treatment
Randomized Controlled Trial
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