CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 33 enrolled
Drug / intervention
Shingrixbiological
Likely dose
Shingrix 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03798691
NCT03798691Phase 4Completed
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A Pilot Study Evaluating Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab

University of Wisconsin, Madison·interventional·Posted Jan 10, 2019·Updated Apr 2, 2025

In Brief

A Phase 4 clinical trial evaluating Shingrix for Inflammatory Bowel Diseases and 3 related conditions. Completed, enrolled 33 participants across 1 site.

Detailed Summary

Inflammatory bowel disease (IBD) is a chronic inflammatory state of the gastrointestinal tract affecting 1.6-3.1 million people in the United States. Patients with IBD are treated with immunosuppressants that increase their risk of herpes zoster (HZ), also known as shingles. Those with IBD have a two-fold increased risk for HZ compared to age matched controls. Because most IBD patients are treated with systemic immunosuppressants, which are an independent risk factor for HZ, the live attenuated HZ vaccine was not recommended. However, the release of the new inactivated HZ vaccine, Shingrix (GlaxoSmithKline), presents new opportunities for preventive care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Herpes Zoster
CountriesUnited States
CollaboratorsBoston Medical Center

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJan 10, 2019
Enrollment StartMay 28, 2019
Primary CompletionOct 12, 2023
Study CompletionSep 10, 2024
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 7.5 years ago

Interventions

Shingrixbiological

Biological: SHINGRIX SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 18 years and older. SHINGRIX is a suspension for injection supplied as a single-dose vial of lyophilized glycoprotein e (ge) antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. A single dose after reconstitution is 0.5 mL. Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later.