Response to Hepatitis B Vaccine in Celiac Disease Patients - Full Text View

Purpose

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.

Condition	Intervention
Celiac Disease	Biological: hepatitis B vaccine (EngerixB)

MedlinePlus related topics:

Celiac Disease Hepatitis Hepatitis B

ChemIDplus related topics:

Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	210
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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) A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscular at zero, one and six months intervals
2: Active Comparator 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 intradermally in the deltoid region at zero, one and six months intervals

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients above 1 year of age with confirmed diagnosis of celiac disease by characteristic symptoms, serology and small bowel biopsy.
Completion of the IM HBV vaccine series in infancy.
HBsAb titer of ≤10mIU/mL at the time of enrollment.

Exclusion Criteria:

Immunocompromised subjects or those receiving medications that may modulate or suppress the immune system (i.e. azathiopurine, 6-MP, steroids).
Inability to obtain written informed consent and patients' assent, as appropriate by the maturity age.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739128

Contacts


Contact: Maskit Bar Meir, MD	0508685507	mbarmeir@gmail.com

Contact: Ari Silbermintz, MD	0508685611	arisilb1@yahoo.com

Locations


Israel
	SZMC	Not yet recruiting
	Jerusalem, Israel
	Contact: Maskit Bar Meir, MD 05086855507 mbarmeir@gmail.com
	Contact: Ari Silbermintz, MD 0508685611 arisilb1@yahoo.com
	Principal Investigator: Ari Silbermintz, MD
	Principal Investigator: Maskit Bar Meir, MD

Sponsors and Collaborators

Shaare Zedek Medical Center

Investigators


Principal Investigator:	Maskit Bar Meir, MD	SZMC

Principal Investigator:	Ari Silbermintz	SZMC

More Information

Responsible Party:	Shaare Zedek Medical Center ( Ari Silbermintz )
Study ID Numbers:	15363.ct.il
First Received:	August 20, 2008
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00739128
Health Authority:	Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:

celiac disease

hepatitis B vaccine

Study placed in the following topic categories:

Liver Diseases

Metabolic Diseases

Gastrointestinal Diseases

Hepatitis, Viral, Human

Intestinal Diseases

Hepatitis

Virus Diseases

Digestive System Diseases

Hepatitis B

Malabsorption Syndromes

Celiac Disease

DNA Virus Infections

Metabolic disorder

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Shaare Zedek Medical Center
Information provided by:	Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:	NCT00739128