Vaccination Against Herpes Zoster in Patients With Inflammatory Rheumatic Diseases

Launched by REGION SKANE · Jan 7, 2025

Keywords

ClinConnect Summary

HZ-REUMA is a Swedish study that looks at how well the shingles vaccine Shingrix works in adults with inflammatory rheumatic diseases who are on medicines that suppress the immune system, compared with similar patients who aren’t on such medicines. All participants will get two shots of Shingrix, given about 1–2 months apart. The main thing researchers will measure is the change in antibodies against shingles before vaccination and about 4–6 weeks after the second dose to see how many people have a strong immune response. They will also look at T-cell responses, check whether protection lasts over 3 and 5 years, and monitor safety and any shingles infections after vaccination.

Who can join? Adults 18 and older with an inflammatory rheumatic disease who are regularly treated at Skåne University Hospital in Lund or Malmö, Sweden. They must either be on modern immune-suppressing medicines (such as methotrexate, TNF blockers, IL-6 inhibitors, anti-CD20 therapies, JAK inhibitors, etc.) or be a control with the disease but no active immunosuppressive treatment (allowing a small daily prednisone dose up to 5 mg). Key exclusions include pregnancy, allergy to vaccine ingredients, current fever or infection, a previous Shingrix shot, or other ongoing immunosuppressive treatment for a different disease. About 240 people are planned to enroll (roughly 190 on immune-suppressing treatment and 50 controls). The study started in late 2024 and runs through 2034, with careful safety monitoring and data privacy; some blood samples will be kept for future research.

Gender

ALL

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