Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab
Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
About this trial
This is an interventional basic science trial for Inflammatory Bowel Diseases
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- University of Wisconsin Digestive Health Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Anti-TNF monotherapy
Vedolizumab
Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine. Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later.
Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine. Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later.