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

NCT06224270 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2024-09-25

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases
  • IBD

Interventions

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.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Freddy Caldera, DO, MS · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06224270 on ClinicalTrials.gov