NCT00739128

Response to Hepatitis B Vaccine in Celiac Disease Patients

Intradermal Immunization Against Hepatitis B Virus in Celiac Disease- a Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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 via a different route of administration (into the skin rather than the muscle) results in a better immunological response in celiac patients. Eligible patients will be randomized to receive a 3-dose vaccination series into the skin or to the muscle. Rate of responders and level of immunity will be compared. This study will facilitate better protection of celiac patients to this potentially deadly virus.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
BIOLOGICAL	hepatitis B vaccine (EngerixB)	A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscular at zero, one and six months intervals
BIOLOGICAL	hepatitis B vaccine (EngerixB)	A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intradermally in the deltoid region at zero, one and six months intervals

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2008-08-21
• Last updated: 2011-04-15

Locations

1 site across 1 country: Israel