Vaccination Against Herpes Zoster in Patients With Inflammatory Rheumatic Diseases

Sponsor
Region Skane
Study ID
NCT06763783
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Giant Cell Arteritis (GCA)
  • Juvenile Chronic Arthritis
  • Polyarthritis
  • Polymyalgia Rheumatica (PMR)
  • Psoriatic Arthritis
  • SLE
  • Scleroderma
  • Spondylarthropathies
  • Systemic Vasculitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Shingrix — DRUG
    all participants vaccinates with two doses of Shingrix vaccine
  • vaccination with 2 doses of Shingrix vaccine — DRUG
    all participants will receive vaccination with 2 doses of Shingrix vaccine. The response to caccine will be compared bitween patients treated with immunosupressive drugs and these not receiving immunosuppresive treatment

Study Details

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

Key Dates

First listed
Jan 8, 2025
Start date
Dec 17, 2024
Status verified
Dec 2024
Primary completion
Dec 31, 2029
Completion
Jun 30, 2034

Study Design

Enrollment
240 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Other: all participants will be vaccinated with two doses Shingrix vaccine
    all participants will be vaccinated but the difference in the antibody and T cells responses to vaccination will be compared between the grupp of patients treated with immunomodulating drigs and patients not receiving such treatments

Primary Outcome Measure

Pre-and post-vaccination anti-gE antibody levels (geometric mean antibody levels, GML) in patients and controls [ Time Frame: before vaccination and 4-6 vecks after the second vaccine dose ]

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