Immunogenicity and Persistence of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
A Prospective Study on the Immunogenicity and Persistence of Hepatitis B Vaccine in Methadone Maintenance Treatment Patients
1 other identifier
interventional
300
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2019
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2019
CompletedFirst Posted
Study publicly available on registry
May 24, 2019
CompletedStudy Start
First participant enrolled
May 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMay 24, 2019
May 1, 2019
8 months
May 23, 2019
May 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-HBs Seroconversion Rate at Month 7
Anti-HBs Seroconversion Rate at month 7 as measured by CMIA
Month 7
Secondary Outcomes (10)
Anti-HBs concentration at month 7
Month 7
Occurrence of Adverse Events After Vaccination
Within 7 days after the vaccination
Anti-HBs Seroconversion Rate at month 12
Month 12
Anti-HBs concentration at month 12
Month 12
Anti-HBs Seroconversion Rate at month 18
Month 18
- +5 more secondary outcomes
Study Arms (3)
20 µg at months 0, 1, and 6
EXPERIMENTAL20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
20 µg at months 0, 1, 2,and 6
EXPERIMENTAL20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6
60 µg at months 0, 1, 2,and 6
EXPERIMENTAL60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6
Interventions
three-dose, 20 µg per dose
four-dose, 20 µg per dose
four-dose, 60 µg per dose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xinghualing Methadone Drug Point
Taiyuan, China
Related Publications (2)
Mo X, Men Z, Gao L, Gao Y, Yao T, Liu Y, Yuan Y, Xue T, Wang F, Wang S, Wang K, Liang X, Feng Y. Immunogenicity persistence after four intramuscular triple-dose or standard-dose hepatitis B vaccine in patients receiving methadone maintenance treatment: A 1-year follow-up study in China. Hum Vaccin Immunother. 2025 Dec;21(1):2447108. doi: 10.1080/21645515.2024.2447108. Epub 2025 Jan 17.
PMID: 39819251DERIVEDFeng Y, Yao T, Gao Y, Li H, Dong S, Wu Y, Liu Y, Li J, Liu C, Liu J, Xue T, Yuan Y, Wu J, Wang F, Liang X, Wang S. Immunogenicity, safety, and compliance of high- and standard-strength four-dose hepatitis B vaccination regimens in patients receiving methadone maintenance therapy in China: a randomized, parallel-arm controlled trial. Expert Rev Vaccines. 2021 Dec;20(12):1629-1635. doi: 10.1080/14760584.2021.1977629. Epub 2021 Sep 16.
PMID: 34503367DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suping Wang, PhD
Shanxi Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 23, 2019
First Posted
May 24, 2019
Study Start
May 26, 2019
Primary Completion
February 1, 2020
Study Completion
December 1, 2023
Last Updated
May 24, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share