Vaccination Against Herpes Zoster in Patients With Inflammatory Rheumatic Diseases

Launched by REGION SKANE · Jan 7, 2025

Keywords

ClinConnect Summary

Patients with inflammatory rheumatic diseases (IRD) such as rheumatoid arthritis (RA), SLE, spondyloarthropathies, systemic vasculitis or systemic sclerosis (Granulomatosis with polyangiitis, GPA; Eosinophilic granulomatosis with polyangiitis, EGPA, Giant Cell Arteritis, GCA), systemic sclerosis or other inflammatory systemic disease) have an increased morbidity and mortality in infections. These infections include the numerous vaccine-preventable diseases such as herpes zoster (HZ). Vaccination is a cost-effective measure to prevent an infection. However, several studies have reported an i...

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Eligibility criteria

• Inclusion Criteria:
• • Adult patients (age 18 years and older) with clinically diagnosed inflammatory rheumatic disease who are regularly followed at Skåne University Hospital, section for rheumatology in Lund and Malmö, Sweden are eligible for the study and will be offered vaccination with 2 doses of Shingrix free of charge. Control group comprises adult patients with inflammatory rheumatic diseases not receiving immunosuppressed drugs but receive 2 doses of Shingrix.
• • age ≥18 years
• • has diagnosed an inflammatory rheumatic disease
• • has a regular follow up at Dept of rheumatology, Skåne University Hospital Lund/Malmö
• • receives active treatment with disease modifying antirheumatic drugs (DMARDs) such conventional synthetic (cs), biologic (b) or targeted synthetic (t) DMARDs \[patients in the study\] or no active treatment with s/b/t DMARDs with exception of daily prednisolone dose of max 5 mg \[controls in the study\]
• • a safe preventive method for women before menopause
• • is able to sign a consent
• Exclusion Criteria:
• • age \<18years
• • pregnancy (women of childbearing potential, WOCBP need to declare the using a safe contraceptive method)
• • allergy/intolerability of any component in the vaccine
• • acute disease and/or fever at the time of vaccination. Fever is defined as temperature ≥ 37.5°C by oral route. (The preferred route for recording temperature in this study will be oral). Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator
• • received Shingrix vaccine previously
• • ongoing treatment with any immunosuppressive drug for other disease with exception for prednisolone in a daily dose corresponding max 5 mg before the inclusion
• • participates or has participated in the other interventional clinical study within 3 months before the inclusion
• • taking concurrently medication which is not approved in EU