drugset / Trial / NCT03962816
Immunogenicity and Persistence of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
Phase 4
Unknown
300 enrolled
Shanxi Medical University
Centers for Disease Control and Prevention, China · collab
RandomizedParallel-groupQuadruple-blindPrevention
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
Timeline
- Start
- 2019-05-26
- Primary completion
- 2020-02
- Completion
- 2023-12
Publications
- 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.
- Feng 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | recombinant hepatitis B vaccine | Vaccine | 20 ug | Intramuscular |
| Subject | recombinant hepatitis B vaccine | Vaccine | 60 ug | Intramuscular |