Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centers for Disease Control and Prevention, China | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 µg at months 0, 1, and 6 | Experimental | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 |
|
| 20 µg at months 0, 1, 2,and 6 | Experimental | 20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6 |
|
| 60 µg at months 0, 1, 2,and 6 | Experimental | 60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6 | Biological | three-dose, 20 µg per dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs Seroconversion Rate at Month 7 | Anti-HBs Seroconversion Rate at month 7 as measured by CMIA | Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs concentration at month 7 | Anti-HBs concentration at month 7 as measured by CMIA | Month 7 |
| Occurrence of Adverse Events After Vaccination | Occurrence of adverse reactions within 7 days after vaccination with the hepatitis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suping Wang, PhD | Contact | #86-351-4135103 | spwang88@163.com | |
| Yongliang Feng, PhD | Contact | #86-351-4135362 | fengyongliang048@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Suping Wang, PhD | Shanxi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinghualing Methadone Drug Point | Taiyuan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39819251 | Derived | 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. | |
| 34503367 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 | Biological | four-dose, 20 µg per dose |
|
| 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 | Biological | four-dose, 60 µg per dose |
|
| Within 7 days after the vaccination |
| Anti-HBs Seroconversion Rate at month 12 | Anti-HBs Seroconversion Rate at month 12 as measured by CMIA | Month 12 |
| Anti-HBs concentration at month 12 | Anti-HBs concentration at month 12 as measured by CMIA | Month 12 |
| Anti-HBs Seroconversion Rate at month 18 | Anti-HBs Seroconversion Rate at month 18 as measured by CMIA | Month 18 |
| Anti-HBs concentration at month 18 | Anti-HBs concentration at month 18 as measured by CMIA | Month 18 |
| Anti-HBs Seroconversion Rate at month 30 | Anti-HBs Seroconversion Rate at month 30 as measured by CMIA | Month 30 |
| Anti-HBs concentration at month 30 | Anti-HBs concentration at month 30 as measured by CMIA | Month 30 |
| Anti-HBs Seroconversion Rate at month 42 | Anti-HBs Seroconversion Rate at month 42 as measured by CMIA | Month 42 |
| Anti-HBs concentration at month 42 | Anti-HBs concentration at month 42 as measured by CMIA | Month 42 |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided