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A Randomized, Opened, Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Young Adults
The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young adults, and the comparative immunogenicity among the three groups will be measured at 1 mon post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore, the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.
Details
| Lead sponsor | Peking University |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 353 |
| Start date | 2014-03 |
| Completion | 2016-12 |
Conditions
- Hepatitis B
Interventions
- Hepatitis B vaccine
Primary outcomes
- Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults — one month after a series vaccination of the regimen
The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and \< 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but \< 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs antibody will be compared among the three vaccine groups.
Countries
China