drugset / Trial / NCT02959775
Immunogenicity of Hepatitis B Vaccination Among Drug Users
Phase 4
Completed
480 enrolled
Shanxi Medical University
Centers for Disease Control and Prevention, China · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
Uptake, adherence, and completion of vaccination among drug users were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect drug users from HBV infection. This is a randomized, open-label, blank-controlled trial, conducted among drug users with drug rehabilitation. This study will compare the immunogenicity and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug users
Timeline
- Start
- 2014-08
- Primary completion
- 2015-05
- Completion
- 2015-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hepatitis B vaccine | Vaccine | 20 ug | Intramuscular |
| Subject | Hepatitis B vaccine | Vaccine | 60 ug | Intramuscular |