What question did this study set out to answer?

This research aims to assess the safety, tolerability, and effectiveness of Shingrix in patients with inflammatory bowel disease who are at risk of herpes zoster.

January 23, 2026

P0767Safety, Tolerability and RealWorld Effectiveness of Recombinant Zoster Vaccine (Shingrix®) in Patients with Inflammatory Bowel Disease: A Prospective SingleCentre Cohort

Key Points

This research aims to assess the safety, tolerability, and effectiveness of Shingrix in patients with inflammatory bowel disease who are at risk of herpes zoster.
Conducted a prospective observational study at a tertiary IBD center.
Offered a standard two-dose RZV schedule (0 and 2 months) to adults with Crohn’s disease or ulcerative colitis.
Recorded adverse events through structured telephone interviews within 7 days after each dose.
Monitored disease activity before and after vaccination using the Harvey-Bradshaw Index and partial Mayo score.
Tracked herpes zoster reactivations for a median of 9 months.
Forty of 92 eligible patients completed the vaccine course, with an adherence rate of 43.5%.
Injection site reactions were reported by 35% after dose 1 and 37.5% after dose 2.
Systemic symptoms occurred in 17.5% and 12.5%, with fever reported by 30% and 32.5% after respective doses.
Seven cases of herpes zoster were documented, resulting in a net incidence of 10%.
No serious adverse events were reported, and no flare-ups of IBD were attributed to vaccination.

Abstract

Abstract Background Patients with inflammatory bowel disease (IBD) are at increased risk of herpes zoster (HZ), a risk that rises further with immunomodulatory therapy. The recombinant zoster vaccine (RZV, Shingrix®) is recommended in this setting, but prospective realworld data remain limited. We assessed the safety, tolerability, and clinical impact of RZV in an IBD cohort. Methods We conducted a prospective observational study at a tertiary IBD centre. Adults ≥18 years with Crohn’s disease (CD) or ulcerative colitis (UC) were offered astandard twodose RZV schedule (month 0–2). Adverse events (AEs) were recorded by structured telephone interview within 7 days after each dose. Disease activity was measured immediately before vaccination and ≥8 weeks after dose 2 using the HarveyBradshaw Index (HBI) for CD and the partial Mayo score for UC. Herpes zoster (HZ) reactivations were monitored threemonthly for a median of 9 months. Results Forty of 92 eligible patients completed the vaccine course (adherence 43.5%; 28 CD, 12 UC; median age 42 years). Thirty participants (75%) were receiving advanced immunomodulatory therapy. Injectionsite reactions occurred in 35.0% after dose 1 and 37.5% after dose 2; systemic symptoms in 17.5% and 12.5%,respectively. Fever was reported by 30.0% and 32.5%; no serious AEs occurred. Seven HZ cases were documented (17.5%; 95% CI 8.7–32.0); three had prior HZ, yielding a “net” incidence of 10.0%. No flare was attributable to vaccination. Conclusion In this reallife prospective cohort, RZV was well tolerated and did not cause IBD flares. Breakthrough HZ occurred in a minority of patients, about half with previous HZ. These data support routine RZV administration in IBD—ideally before, but also during, immunomodulatory therapy—while highlighting the need for larger multicentre studies to define longterm protection and predictorsof vaccine failure. Conflict of interest: Prof. Ribaldone, Davide Giuseppe: No conflict of intereset Vernero, Marta: Stella, Andrea:

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