NCT03798691CompletedPhase 4
Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab
A Pilot Study Evaluating Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab
Source: ClinicalTrials.gov · Last updated 2 Apr 2025
Brief summary (registry, in English)
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 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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 2 Jan 2019
- Start date
- 28 May 2019
- Primary completion date
- 12 Oct 2023
- Lead sponsor
- University of Wisconsin, Madison
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT03798691
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 33
- From 28 May 2019 to the primary completion date, 12 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous receipt of any HZ vaccine
- 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.
Other illness
- 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.
- Unable to provide appropriate informed consent due to being illiterate or impairment in decision-making capacity.
Age
- Patient is pregnant per self-reporting or older than age 70 years
Other
- Patient cannot or will not provide written informed consent.
- Patient is being administered immunomodulators currently or within the past three months
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Wisconsin Digestive Health Center Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.