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

Ulcerative Colitis Clinical Trial

Official title:
A Pilot Study Evaluating Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03798691
Study type Interventional
Source University of Wisconsin, Madison
Contact
Status Active, not recruiting
Phase Phase 4
Start date May 28, 2019
Completion date September 2024
View Details
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