drugset / Trial / NCT01159457

Comparison of Engerix B Vaccine Versus Sci-B-Vac Vaccine in Celiac Patients

NCT01159457

Unknown 210 enrolled Shaare Zedek Medical Center
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

EvaluationDrugModalityDoseRoute
Comparator Engerix-B Vaccine 10 ug Intramuscular
Comparator Sci-B-Vac Vaccine 5 ug Intramuscular
Comparator Sci-B-Vac Vaccine 10 ug Intramuscular

Indications