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

  • STATUS
    Recruiting
  • End date
    Dec 29, 2023
  • participants needed
    30
  • sponsor
    University of Wisconsin, Madison
Updated on 29 May 2022
adalimumab
immunosuppressive agents
infliximab
tumor necrosis factor
ulcerative colitis
inflammatory bowel disease
vedolizumab
crohn's disease
enteropathy
golimumab
certolizumab pegol
herpes
colitis
ulceration
varicella
immunomodulators
certolizumab
chickenpox
zoster vaccine
shingrix
subunit vaccine
intestinal diseases

Summary

Inflammatory bowel disease (IBD) is a chronic inflammatory state of the gastrointestinal tract(1) affecting 1.6-3.1 million people in the United States. Patients with IBD are treated with immunosuppressants that increase their risk of herpes zoster (HZ), also known as shingles.

Those with IBD have a two-fold increased risk for HZ compared to age matched controls. Because most IBD patients are treated with systemic immunosuppressants, which are an independent risk factor for HZ, the live attenuated HZ vaccine was not recommended. However, the release of the new inactivated HZ vaccine, Shingrix (GlaxoSmithKline), presents new opportunities for preventive care.

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 (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.

Details
Condition Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Herpes Zoster
Treatment Shingrix
Clinical Study IdentifierNCT03798691
SponsorUniversity of Wisconsin, Madison
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

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
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