drugset / Trial / NCT01159457
Comparison of Engerix B Vaccine Versus Sci-B-Vac Vaccine in Celiac Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
Celiac disease and infection with hepatitis B virus (HBV) are very prevalent worldwide and carry a high morbidity rate. It has been recently shown that patients with celiac disease very often fail to develop immunity after standard vaccination for HBV during infancy. In this study, we will evaluate whether a second vaccination series with a different vaccine, Sci-B-Vac, results in a better immunological response in celiac patients. Eligible patients will be randomized to receive a 3-dose vaccination series with Engerix or Sci-B-Vac vaccines.. Rate of responders and level of immunity will be compared. This study will facilitate better protection of celiac patients to this potentially deadly virus.
Timeline
- Start
- 2011-04
- Primary completion
- 2012-06
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Engerix-B | Vaccine | 10 ug | Intramuscular |
| Comparator | Sci-B-Vac | Vaccine | 5 ug | Intramuscular |
| Comparator | Sci-B-Vac | Vaccine | 10 ug | Intramuscular |