An interventional study of hepatitis B vaccine (EngerixB) and hepatitis B vaccine (EngerixB) in Celiac Disease, sponsored by Shaare Zedek Medical Center. Terminated at 1 site in Israel. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2011-04-15.
Sponsored by Shaare Zedek Medical Center · Not applicable, Interventional, and Treatment
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.
339 studies on the registry are indexed under Celiac Disease; 80 are open to participants now.
This study's planned enrollment of 210 is above the median of 50 across 207 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →Shaare Zedek Medical Center is the lead sponsor of 194 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intramuscular route
Biological: hepatitis B vaccine (EngerixB)
celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intradermal route
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
Also known as: EngerixB, GSK
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
Also known as: (EngerixB, GSK)
1. The primary endpoint of the study will be comparison of the geometric mean titers of anti-HBs between the intradermal and the intramuscular groups.
Time frame: two years
1. Rate of responders four weeks after the completion of the series 2. Rate and characteristics of adverse drug reactions 3. Numerical increase in the antibodies titer before and after vaccination 4. Rate of responders in the cross over phase
Time frame: two years
The record gives a start of Feb 2009, a primary completion of Mar 2011 and a completion of Mar 2011. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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