NCT06224270

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

Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Adults with Inflammatory Bowel Disease on Biologic Immunosuppressive Therapies

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 a 10% 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.

Conditions

• Inflammatory Bowel Diseases
• IBD

Interventions

Type	Name	Description
BIOLOGICAL	Adjuvanted Recombinant Zoster Vaccine (RZV)	The RZV vaccine is indicated for prevention of herpes zoster (HZ) in adults aged 18 years and older who are or will be at increased risk of HZ. Patients with IBD on immunosuppressive therapy are at increased risk for HZ.

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2024-01-25
• Last updated: 2024-09-25

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study