Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab

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 (TNF) monotherapy.

The study will evaluate humoral and cell mediated immunity in patients with IBD on
vedolizumab who receive the two-dose herpes zoster vaccine. The investigators will evaluate
short term, one month after second vaccination dose and sustained immunogenicity at 6 and 12
months post vaccination.

The central hypothesis of this proposal is that IBD patients on vedolizumab should be able to
mount a normal vaccine response comparable to those on anti-TNF monotherapy who might benefit
from a third dose of the subunit vaccine as has been evaluated in HIV and transplant
populations. The hypothesis is that IBD patients on vedolizumab will be able to mount a
superior response to those on anti-TNF therapy. A recent study showed that hepatitis B
vaccine immunogenicity was not affected by vedolizumab.

The study population will include adult patients aged 50 or older with IBD(diagnosed by
standard clinical, radiographic, endoscopic, and histopathologic criteria) receiving care at
University of Wisconsin Hospital and Clinics or Boston Medical Center. There is no
randomization or use of placebo in this study. Two study groups (each containing 15 subjects)
will be established Group A: Patients with IBD on anti-TNF monotherapy and Group B patients
with IBD on vedolizumab monotherapy.

Methods: Eligible patients with IBD will be recruited from the University of Wisconsin
Hospital and Clinics or from Center for Digestive Diseases at Boston Medical Center.

Inclusion Criteria:

1. Patient is between the ages of 50-70 years, inclusive.

2. 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

3. Patient has a history of ulcerative colitis (UC) or Crohn's disease diagnosed by
standard clinical, radiographic, endoscopic, and histopathologic criteria.

4. Patient is receiving one of the following treatments for their IBD Group A: Anti-TNF
monotherapy (adalimumab, certolizumab, golimumab, infliximab) Group B: Vedolizumab
monotherapy

5. Patient has been on stable treatment for IBD for at least three months.

Exclusion Criteria:

1. Previous receipt of any HZ vaccine

2. Allergy to zoster vaccine or a component of it

3. Other underlying chronic medical condition that could affect immunogenicity to
vaccines (rheumatoid arthritis, etc.)

4. History of herpes zoster or post herpetic neuralgia within the past year.

5. Patient cannot or will not provide written informed consent.

6. Patient is being administered immunomodulators currently or within the past three
months

7. Patient has been taking any dose of oral or intravenous steroids within 30 days prior
to immunization.

8. Patient has received polyclonal immunoglobulin therapy or blood products within the
last year.

9. Patient is pregnant per self-reporting or older than age 70 years

10. Unable to provide appropriate informed consent due to being illiterate or impairment
in decision-making capacity.