Response to Hepatitis B Vaccine in Celiac Disease Patients

NCT00739128 | Terminated

• 1 other identifier: 15363.ct.il
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

celiac disease; hepatitis B vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  two years

Secondary Outcomes (1)

• 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

  two years

Study Arms (2)

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)

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)

Interventions

hepatitis B vaccine (EngerixB) BIOLOGICAL

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

1

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

SZMC

Jerusalem, Israel

Location

MeSH Terms

Conditions

Celiac Disease; Hepatitis B

Interventions

Hepatitis B Vaccines; halofantrine

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Maskit Bar Meir, MD

  Shaheed Ziaur Rahman Medical College

  PRINCIPAL INVESTIGATOR

• Ari Silbermintz

  Shaheed Ziaur Rahman Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 21, 2008
• Study Start: February 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 15, 2011

Record last verified: 2011-04

Locations

IL (1)