Vaccination Against Herpes Zoster in Patients With Inflammatory Rheumatic Diseases

Summary

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

Conditions

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

Interventions

DRUG

Shingrix

all participants vaccinates with two doses of Shingrix vaccine

DRUG

vaccination with 2 doses of Shingrix vaccine

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

Sponsors & Collaborators

• GlaxoSmithKline

  collaborator INDUSTRY

• Region Skane

  lead OTHER

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-17

Primary Completion

2029-12-31

Completion

2034-06-30

Countries

• Sweden

Study Locations