Study of Response to Zoster Vaccine in Adults with Inflammatory Bowel Disease Treated with Medications

Withdrawn before enrolling · Phase 4

Conditions studied: Inflammatory Bowel Diseases, IBD

In brief

This multi-center study will evaluate the safety and immune response to recombinant zoster vaccine (RZV) series in 264 patients with inflammatory bowel disease (IBD) on immunosuppressive therapy recruited from 6 study sites who can expect to be on study for up to 14 months.

Key facts

Study ID: NCT06224270
Run by: University of Wisconsin, Madison
People needed: 0
Starts: 2024-10-01
Expected to finish: 2027-09-01
Last updated by the study team: 2024-09-25

Who can join

Age: 19 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient is between the ages of 19 and 85 years with a diagnosis of IBD based on standard clinical and histological criteria.
Can provide appropriate written informed consent.
Patient has a history of ulcerative colitis or Crohn's disease diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria.
Patient is receiving one of the following treatments for their IBD:
Anti-TNF therapy (infliximab, adalimumab, certolizumab, or golimumab)
On anti-TNF monotherapy
Or anti-TNF therapy in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6-Mercaptopurine (6MP) 0.5mg/kg
Non-TNF therapy
On ustekinumab monotherapy or in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
On vedolizumab monotherapy or in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
On Risankizumab monotherapy or in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
On mirikizumab monotherapy or in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
Janus Kinase Inhibitor
On tofacitinib at least 5mg PO twice per day (BID)
On upadactinib at least 15mg PO BID
Patient has been on stable biologic or JAK treatment for IBD for at least two months.
Patient is in stable clinical remission
o No recent corticosteroid prescription within the past two months.
Female participant of non-childbearing potential (pre-menarche, current tubal ligation, hysterectomy, oophorectomy or post-menopause) and childbearing potential (if they had: practiced adequate contraception (include IUD or equivalent, hormonal contraceptive (e.g. pill, patch, ring, implant or an injection used consistently and that has reached full effect prior to the first dose of vaccine), hysterectomy and/or a bilateral tubal ligation or bilateral oophorectomy) for 1 month prior to vaccination and agrees to continue adequate contraception during the primary treatment period, and for 2 months after completion of the vaccination series). Non-pregnant females with a negative pregnancy test who are willing to practice adequate contraception during the primary treatment period, and for 2 months after completion of the vaccination series).

You may not qualify if…

Patient cannot or will not provide written informed consent.
Patient has been taking any dose of oral or intravenous steroids for more than 3 days within 2 months prior to immunization.
Any confirmed or suspected HIV, primary immunodeficiency disease, disseminated or untreated malignancy, or systemic infection.
Previous vaccination against HZ or varicella within the 12M preceding the first dose of RZV.
Occurrence of varicella or HZ per clinical history, within the 12M preceding the first dose of RZV.
Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to the use of induction and/or maintenance immunosuppressive therapies.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment.
Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe.
Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 3 (i.e. 2 months after last dose of study V2).

Where it is running

Mayo Clinic — Jacksonville, Florida, United States
Mercy Medical Center — Baltimore, Maryland, United States
New York University — New York, New York, United States
University of North Carolina — Chapel Hill, North Carolina, United States
Vanderbilt University — Nashville, Tennessee, United States
UW Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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