Trials / Completed
CompletedNCT02991599
Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Methadone Maintenance Treatment Patients in China: a Randomized Controlled Trial
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 196 (actual)
- Sponsor
- Shanxi Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 60 µg dose hepatitis B vaccine | three-dose, 60 µg per dose |
| BIOLOGICAL | 20 µg dose hepatitis B vaccine | three-dose, 20 µg per dose |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2015-07-01
- Completion
- 2018-05-01
- First posted
- 2016-12-13
- Last updated
- 2021-12-23
- Results posted
- 2019-07-30
Source: ClinicalTrials.gov record NCT02991599. Inclusion in this directory is not an endorsement.