Status:
COMPLETED
Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Boston Medical Center
Conditions:
Inflammatory Bowel Diseases
Crohn Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Inflammatory bowel disease (IBD) is a chronic inflammatory state of the gastrointestinal tract affecting 1.6-3.1 million people in the United States. Patients with IBD are treated with immunosuppressa...
Detailed Description
The purpose of this study is to determine the immunogenicity of the herpes zoster subunit vaccine in inflammatory bowel disease patients on vedolizumab compared to those on anti-tumor necrosis factor ...
Eligibility Criteria
Inclusion
- Patient is between the ages of 18-70 years, inclusive.
- History of primary varicella infection (chicken pox) Confirmed by a previous history of positive varicella zoster virus (VZV) Immunoglobulin G antibody or history of chicken pox
- Patient has a history of ulcerative colitis (UC) or Crohn's disease diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria.
- Patient is receiving one of the following treatments for their IBD Group A: Anti-TNF monotherapy (adalimumab, certolizumab, golimumab, infliximab) Group B: Vedolizumab monotherapy
- Patient has been on stable treatment for IBD for at least three months.
Exclusion
- Previous receipt of any HZ vaccine
- Allergy to zoster vaccine or a component of it
- Other underlying chronic medical condition that could affect immunogenicity to vaccines (rheumatoid arthritis, etc.)
- History of herpes zoster or post herpetic neuralgia within the past year.
- Patient cannot or will not provide written informed consent.
- Patient is being administered immunomodulators currently or within the past three months
- Patient has been taking any dose of oral or intravenous steroids within 30 days prior to immunization.
- Patient has received polyclonal immunoglobulin therapy or blood products within the last year.
- Patient is pregnant per self-reporting or older than age 70 years
- Unable to provide appropriate informed consent due to being illiterate or impairment in decision-making capacity.
Key Trial Info
Start Date :
May 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03798691
Start Date
May 28 2019
End Date
September 10 2024
Last Update
April 2 2025
Active Locations (1)
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1
University of Wisconsin Digestive Health Center
Madison, Wisconsin, United States, 53705