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OpenTrials
Completed

NCT Number: NCT01531075

Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease

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

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Key information

Conditions

Inflammatory Bowel Disease Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Inflammatory Bowel Diseases Intestinal Diseases Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soroka UMC

Beersheba, 84101, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Primary outcomes

  1. protective level of anti HBs antibodies

    Time frame: 1 month after the last does of vaccine

    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.

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Official study title

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

Acronym: HBV VIP

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Feb 10, 2012
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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