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Immunogenicity and Persistence of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients

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ClinicalTrials.gov Identifier: NCT03962816
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
Centers for Disease Control and Prevention, China
Information provided by (Responsible Party):
Suping Wang, Shanxi Medical University

Brief Summary:

At present, Methadone Maintenance Treatment Patients of Hepatitis B Vaccination in are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.

This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in Methadone Maintenance Treatment Patients


Condition or disease Intervention/treatment Phase
Hepatitis B Vaccine Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6 Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 Phase 4

Detailed Description:
Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective Study on the Immunogenicity and Persistence of Hepatitis B Vaccine in Methadone Maintenance Treatment Patients
Estimated Study Start Date : May 26, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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

Experimental: 20 µg at months 0, 1, 2,and 6
20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6
Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
four-dose, 20 µg per dose

Experimental: 60 µg at months 0, 1, 2,and 6
60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6
Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
four-dose, 60 µg per dose




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


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. 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

  3. Anti-HBs Seroconversion Rate at month 12 [ Time Frame: Month 12 ]
    Anti-HBs Seroconversion Rate at month 12 as measured by CMIA

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

  5. Anti-HBs Seroconversion Rate at month 18 [ Time Frame: Month 18 ]
    Anti-HBs Seroconversion Rate at month 18 as measured by CMIA

  6. Anti-HBs concentration at month 18 [ Time Frame: Month 18 ]
    Anti-HBs concentration at month 18 as measured by CMIA

  7. Anti-HBs Seroconversion Rate at month 30 [ Time Frame: Month 30 ]
    Anti-HBs Seroconversion Rate at month 30 as measured by CMIA

  8. Anti-HBs concentration at month 30 [ Time Frame: Month 30 ]
    Anti-HBs concentration at month 30 as measured by CMIA

  9. Anti-HBs Seroconversion Rate at month 42 [ Time Frame: Month 42 ]
    Anti-HBs Seroconversion Rate at month 42 as measured by CMIA

  10. Anti-HBs concentration at month 42 [ Time Frame: Month 42 ]
    Anti-HBs concentration at month 42 as measured by CMIA



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment
  • Sign informed consent, willing to participate in this study

Exclusion Criteria:

  • Being pregnant
  • Intolerance or allergy to any component of the vaccine
  • Any vaccination during the month preceding enrollment
  • Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
  • Patient with HIV Infection
  • The use of immunosuppressive agents in patients with nearly three months

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): NCT03962816


Contacts
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Contact: Suping Wang, PhD #86-351-4135103 spwang88@163.com
Contact: Yongliang Feng, PhD #86-351-4135362 fengyongliang048@163.com

Locations
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China
Xinghualing Methadone Drug Point Not yet recruiting
Taiyuan, China
Contact: Yongliang Feng, PhD    #86-351-4135362    fengyongliang048@163.com   
Sponsors and Collaborators
Shanxi Medical University
Centers for Disease Control and Prevention, China
Investigators
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Principal Investigator: Suping Wang, PhD Shanxi Medical University

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Responsible Party: Suping Wang, Professor, Shanxi Medical University
ClinicalTrials.gov Identifier: NCT03962816     History of Changes
Other Study ID Numbers: 2018ZX10721202001002002
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 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
Randomized Controlled Trial
Methadone Maintenance Treatment Patients
Immunogenicity
Long-term Immune Response
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
Methadone
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents