Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease

NCT01531075 | Completed

• 1 other identifier: sor026511ctil
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to assess the efficacy of Hepatitis B Virus vaccination in a population of IBD patients treated with immunosuppressive medications.

Conditions

Inflammatory Bowel Disease

Keywords

HBV, Inflammatory bowel disease, immunosuppressor

Outcome Measures

Primary Outcomes (1)

• protective level of anti HBs antibodies

  Antibody titer \>10 IU/ml 30 days following last vaccine dose will be considered protective. In the work done by Altunoz et al., titer rate below 10 IU was observed in 40% of the patients, while 40% of the patients achieved a rate of above 100 IU. Therefore, we can estimate that the geometric mean of distribution is approx. 50 IU. A sample size of 37 patients in each group achieves a power of 80% to detect a ratio above 1.37 between the two vaccinated groups.

  1 month after the last does of vaccine

Study Arms (2)

ENGERIX-B

EXPERIMENTAL

Biological: ENGERIX-B (HBV Vaccine)

Sci-B-Vac

EXPERIMENTAL

Biological: Sci-B-Vac

Interventions

ENGERIX-B (HBV Vaccine) BIOLOGICAL

ENGERIX-B (Hepatitis B Vaccine) 20 mcg, A series of 3 doses (1 mL each) given on a 0-, 1-, 6-month schedule.

Also known as: ENGERIX-B

ENGERIX-B

Sci-B-Vac BIOLOGICAL

Sci-B-Vac (Hepatitis B Vaccine) 10 μg/ml, A series of 3 doses (1 mL each) given on a 0-, 1-, 6-month schedule.

Sci-B-Vac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/female ≥ 18 years of age
• Evidence of IBD as diagnosed by clinical, laboratory imaging and endoscopic criteria.
• Treated with at least one immunosuppressive medication at the time of study initiation
• Provided written informed consent.

You may not qualify if:

• Pregnant women
• Diagnosis of chronic viral hepatitis B
• Any major acute medical event in the 30 days prior to recruitment that necessitated hospitalization ( acute myocardial infarction, CVA, pulmonary emboli, sepsis, major trauma)
• Any other chronic inflammatory condition not related to IBD ( connective tissue disease, Chronic liver disease, COPD, poorly controlled diabetes mellitus)
• Active hematologic or oncologic diseases

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Soroka UMC

Beersheba, 84101, Israel

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Hepatitis B

Interventions

Engerix-B; Pre-S vaccine

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases

Study Officials

• Ohad Etzion, MD

  Soroka UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician, Department of Gastroenterology and Liver Disease

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 10, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: April 21, 2020

Record last verified: 2020-04

Locations

IL (1)