Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease

Inflammatory Bowel Disease Clinical Trial

— HBV VIP  

Official title:

Assessment of Hepatitis B Vaccination Efficacy in Patients With Inflammatory Bowel Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531075
• Other study ID #: sor026511ctil
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: August 2016

Study information

• Verified date: April 2020
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hepatitis B
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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

Locations

Country	Name	City	State
Israel	Soroka UMC	Beer- Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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