Safety of the Adjuvant Recombinant Herpes Zoster Vaccine in Crohn's Disease and Ulcerative Colitis: A Real-World Study

초록

Background:The incidence of inflammatory bowel disease (IBD) is increasing, and herpes zoster (HZ) occurrence in IBD patients, particularly those on immunosuppressive drugs, is a growing concern. The herpes zoster adjuvant recombinant vaccine (Shingrix) may provide a safer alternative to live vaccines, but real-world data on its safety in IBD patients is limited.Methods:This multicenter prospective observational study is being conducted from August 2023 to July 2025. Patients diagnosed with Crohn’s disease (CD) or ulcerative colitis (UC) who receive the herpes zoster subunit vaccine will be followed for 30 days post-vaccination to assess adverse events (AE) and vaccine safety.Results:A total of 244 patients were enrolled in the study, consisting of 141 with ulcerative colitis (UC) and 103 with Crohn’s disease (CD). The mean age of the cohort was 45.3 years, with UC patients being older on average (49.7 years) than CD patients (39.3 years, p<0.01). After the first dose, injection site pain was the most commonly reported local adverse event, occurring in 51.2% of patients (UC: 49.6%, CD: 53.4%; p=0.56). Other local adverse events, such as redness (2.0%) and swelling (1.2%), showed no significant differences between UC and CD groups (p>0.05).Systemic adverse events following the first dose included fatigue (19.3%), myalgia (34.0%), headache (16.0%), shivering (11.5%), fever (11.5%), and gastrointestinal symptoms (6.6%). There were no significant differences between UC and CD patients for these events (p>0.05). Rare severe adverse events were noted, including one case of a disease flare requiring hospitalization in a CD patient post-vaccination (0.4%). Additional events classified as 'others' included itching, Bell’s palsy, and dizziness, with no significant group differences.For the second dose, 132 patients (UC: 78, CD: 54) were followed. Local adverse events included injection site pain reported by 53.8% of patients (UC: 48.7%, CD: 61.1%; p=0.16). Systemic adverse events, such as fatigue (25.8%), myalgia (35.6%), and headache (15.9%), were similarly reported without significant differences between UC and CD groups (p>0.05). Severe adverse events were not observed after the second dose. Other non-severe adverse events reported included sore throat, nausea, and rash, with no group-specific statistical significance.Conclusion:The herpes zoster adjuvant recombinant vaccine appears to be safe for use in IBD patients, with no significant differences in adverse events between UC and CD groups. This study suggests that the adjuvant vaccine is a viable alternative to live attenuated vaccines, especially in patients receiving immunosuppressive therapy. Further studies are warranted to confirm its long-term safety and efficacy in this population.