Safety of Recombinant Zoster Vaccine in Patients with Inflammatory Bowel Disease

Abstract

Background: Patients with inflammatory bowel disease (IBD) are at increased risk of developing herpes zoster. In October 2017, the FDA approved a two-dose adjuvanted, recombinant herpes zoster vaccine (RZV). There is a theoretical concern that vaccine adjuvants may cause flares in patients with immune-mediated diseases. We aimed to assess the rates of IBD flare and adverse reactions after administration of RZV in a cohort of patients with IBD.

Methods: We conducted a prospective observational study of patients with IBD who received RZV between February 2018 and July 2019 at a tertiary IBD referral center. IBD activity scores were collected from patients during office visit or phone call after vaccination. The primary outcome was rate of IBD flare, defined as an increase in IBD activity, resulting in escalation of medical therapy, following vaccination. The secondary outcomes were rates of local and systemic adverse reactions after vaccination.

Results: We identified 67 patients (28 with ulcerative colitis and 39 with Crohn's disease) who received at least one dose of RZV. The two-dose vaccine series was completed by 55 patients (82%). Median duration of follow-up after vaccination was 207 days. One case of IBD flare was identified. No cases of herpes zoster were identified. Local and systemic adverse reactions were reported in 74.6% and 56.7% of patients, respectively.

Conclusions: In this cohort of 67 patients, a low rate of IBD flare (1.5%) was observed after RZV administration. Rates of local and systemic adverse reactions were comparable to those seen in the RZV clinical trials.

Keywords: Crohn’s disease; Herpes zoster; Inflammatory bowel disease; Ulcerative colitis; Vaccination; Vaccine adjuvant.