Study of Response to Zoster Vaccine in Adults With Inflammatory Bowel

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Study Visits: - Visit 1 (V1) - day 1 - blood draw, RZV dose 1 - Follow up (FU) 1 - between days 7-15 - FU 2 - between days 22-29 - Visit 2 (V2) - between days 30-90 - RZV dose 2 - FU 3 - V2 + 7-14 days - Visit 3 (V3) - V2 + 21-50 days - blood draw - Visit 4 (V4) - V2 + approximately 360 days - blood draw Primary Objective: • To demonstrate higher humoral immunogenicity following two doses of RZV in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy. Secondary Objectives: - To evaluate the vaccine response rate (VRR) for anti-glycoprotein E (gE) humoral immune responses in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy. - To characterize the anti-gE humoral immunogenicity at visit 1 (V1), visit 3 (V3), and visit 4 (V4) in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy. - To evaluate the safety and reactogenicity following administration of RZV, up to 30 days post-last vaccination and during the entire post-vaccination follow-up period. - To evaluate IBD activity following administration of RZV, up to 30 days post-last vaccination and during the entire post-vaccination follow-up period. Tertiary/Exploratory Objectives: - To characterize gE-specific CD4+ T-cell mediated immune responses in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy. - To characterize gE-specific CD4+ T-cell mediated immune responses in patients on JAKs. - To evaluate the VRR for anti-gE humoral immune responses in patients on Janus Kinase inhibitors (JAKs). - To characterize the anti-gE humoral immunogenicity at V1, V3, and V4 in patients on JAKs. - To determine the relationship between gut microbiota and response to RZV series. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06224270
Study type	Interventional
Source	University of Wisconsin, Madison
Contact	Ali Moellner, MPH
Phone	(608) 265-5229
Email	moellner@wisc.edu
Status	Not yet recruiting
Phase	Phase 4
Start date	June 2024
Completion date	July 2027

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms