Vaccination Against Herpes Zoster in Patients With Inflammatory Rheumatic Diseases

NCT06763783 · tracked via the Priya Life Science Sweden tracker

Sponsor

Region Skane

Phase

Phase 4

Started

2024-12-17

Last updated

2025-01-10

Condition(s) studied

Systemic VasculitisSpondylarthropathiesPsoriatic ArthritisSclerodermaPolymyalgia Rheumatica (PMR)Juvenile Chronic ArthritisPolyarthritisSLEGiant Cell Arteritis (GCA)

Investigational drug(s) / intervention(s)

Shingrix →vaccination with 2 doses of Shingrix vaccine

Shingrix: all participants vaccinates with two doses of Shingrix vaccine

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

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Pre-and post-vaccination anti-gE antibody levels (geometric mean antibody levels, GML) in patients and controls — before vaccination and 4-6 vecks after the second vaccine dose
Measurement of pre-and post-vaccination anti-gE antibody (g/L) in patients and controls which will be used for calculating the proportion of individuals in different treatments group and controls with ≥4-fold increase in anti-gE antibody measured 4-6 weeks following the second vaccine dose (vaccine response rate)

Trial sites (1)

Facility	City	Region	Status
Skåne University Hospital, section for rheumatology	Lund	Sweden

More Region Skane trials in Sweden

Sustainable Hypertension Management in Primary Health Care in Sweden Recruiting

Biomarkers After Out-of-hospital Cardiac Arrest- a STEPCARE Substudy Active, not recruiting

Comparison of Cloxacillin and Benzylpenicillin in Penicillin Susceptible S. Aureus Bacteraemia Recruiting

The Study Tests if Preoperative Dental Screening is Superior to no Preoperative Dental Screening in Improving the Outcome of Patients Undergoing Surgical Cardiac Valve Replacement or Transcatheter Cardiac Valve Implantation. Recruiting

Evaluation of Three Tests to Assess Social Cognition in Huntington Disease Recruiting

Other trials for the same condition

Combined High-Intensity Aerobic Training and Resistance Training in Psoriatic Arthritis Starting soon

A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy Active, not recruiting

GOTHA - The Early Arthritis and Psoriasis Study of Region Västra Götaland, Sweden Enrolling by invitation

The VGR GCA Cohort: Ultrasound, Biopsy and Biomarkers - Novel Methods for Diagnosis, Monitoring and Prognosis in Giant Cell Arteritis. Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06763783 on ClinicalTrials.gov ↗ ← All trials in Sweden