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

Inflammatory Bowel Diseases Clinical Trial

Official title: Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Adults With Inflammatory Bowel Disease on Biologic Immunosuppressive Therapies

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. ;

Related Conditions & MeSH terms

• IBD
• Inflammatory Bowel Diseases
• Intestinal Diseases

• 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