Response to Hepatitis B Vaccine in Celiac Disease Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Celiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intramuscular route

Group Type ACTIVE_COMPARATOR

hepatitis B vaccine (EngerixB)

Intervention Type BIOLOGICAL

A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscular at zero, one and six months intervals

2

celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intradermal route

Group Type ACTIVE_COMPARATOR

hepatitis B vaccine (EngerixB)

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type 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

Intervention Type BIOLOGICAL

Other Intervention Names

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EngerixB, GSK (EngerixB, GSK)

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No