Shingles Vaccine Response in People With Inflammatory Rheumatic Diseases

Trial details

Who runs it

Region Skane

Trial code

NCT06763783

Record updated

10 January 2025

Original description

The purpose of HZ-REUMA study is explore vaccine response and protection against shingles (herpes zoster, HZ) after vaccination with two doses of Shingrix in immunosuppressed patients with inflammatory rheumatic diseases (IRD) compared to immunocompetent patients with IRD (controls).Read full original descriptionShow less

Vaccination in Patients With Inflammatory Rheumatic Diseases. The Impact of Anti-rheumatic Treatments on the Immunogenicity of Herpes-zoster Vaccine (Shingrix) and Protection Against Infection (HZ-REUMA)

The purpose of HZ-REUMA study is explore vaccine response and protection against shingles (herpes zoster, HZ) after vaccination with two doses of Shingrix in immunosuppressed patients with inflammatory rheumatic diseases (IRD) compared to immunocompetent patients with IRD (controls).

Hypothesis:

The immunological disturbance as part of the rheumatic disease in combination with different immunomodulating treatments may impair vaccine response to non-live HZ vaccine (Shingrix) and thereby lead to an insufficient protection against infection.

Primary objective (outcome)

1. The impact of modern anti-rheumatic treatments including synthetic disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate and different biological treatments (anti-TNF, anti IL6r, anti-IL12/23/17, anti-CD20, anti-BlyS, anti-INFERON treatment, or targeted DMARDs (JAK-inhibitors) on antibody response elicited by two doses of subunit vaccine against herpes zoster (HZ) administrated 1-2 months apart in patients with IRD.

Secondary outcomes 2. The numbers and frequency of antigen specific CD4 2+ T cells expressing ≥2 or more activation markers (TNFalpha, INF-gama, interleukin-2 or CD40ligand) 3. Long-term immunogenicity of two doses of Shingrix in immunosuppressed patients with IRD measured 3 and 5 after vaccination 4. the tolerability of the vaccine, the impact on existing rheumatic disease, and possible association with onset of new autoimmune diseases 5. if vaccination against herpes zoster protects against infections in patients with inflammatory rheumatic diseases

Study Population Adult patients (18 years and older) with a clinically diagnosed inflammatory rheumatic disease and regularly followed at Skåne University Hospital, section for rheumatology in Lund/Malmö, Sweden are eligible for the study and will be offered vaccination free of charge. Control group comprises adult individuals with known inflammatory rheumatic disease without immunosuppressive treatment except for low dose prednisone (max 5 mg daily) .

Inclusion criteria:

* age ≥18 years (patients) * regular follow up at Skåne University Hospital, section for rheumatology Lund/Malmö due to an inflammatory rheumatic disease (patients) * receive active treatment with disease modifying anti-rheumatic drugs (DMARDs) such conventional synthetic (cs), biologic (b) or targeted synthetic (ts) DMARDs or patients without active immunosuppressive treatment (controls)

Exclusions criteria

* age <18 years (patients) * pregnancy (women of childbearing potential, WOCBP, are not excluded since all patients using DMARDs are advised to use a safe and effective contraceptive method) * allergy/intolerability of any component in the vaccine * active infection inclusive herpes zoster (shingles) * received Shingrix vaccine previously * ongoing treatment with any immunosuppressive drug for the other diseases Target enrolment/sample size: 240. Study start date: December, 17 2024- June 30, 2029

Inclusion: 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: 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; 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; age <18years; pregnancy (women of childbearing potential, WOCBP need to declare the using a safe contraceptive method).

ClinicalTrials.gov NCT06763783