Vaccination Against Herpes Zoster in Patients With Inflammatory Rheumatic Diseases

NCT06763783 | Enrolling By Invitation Phase 4 DMC

• 1 other identifier: 2023-506230-71-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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)

• 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)

Keywords

herpes zoster; vaccine response; inflammatory rheumatic disease

Outcome Measures

Primary Outcomes (1)

• Pre-and post-vaccination anti-gE antibody levels (geometric mean antibody levels, GML) in patients and controls

  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)

  before vaccination and 4-6 vecks after the second vaccine dose

Secondary Outcomes (4)

• Number and function of antigen (vaccine) specific T cells

  before vaccination and 4-6 weeks after second vaccine dose

• long-term immunogenicity

  3 and 5 years after inclusion

• the tolerability of the vaccine

  from inclusion to 6 months after the inclusion of last patient

• number of HZ infections in vaccinated individuals

  from 1 months after the second vaccine dose to the study end 2034

Study Arms (1)

all participants will be vaccinated with two doses Shingrix vaccine

OTHER

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

Drug: Shingrix; Drug: vaccination with 2 doses of Shingrix vaccine

Interventions

Shingrix DRUG

all participants vaccinates with two doses of Shingrix vaccine

all participants will be vaccinated with two doses 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

all participants will be vaccinated with two doses Shingrix vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• taking concurrently medication which is not approved in EU

Sponsors & Collaborators

• Region Skane: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Skåne University Hospital, section for rheumatology

Lund, SE-221 85, Sweden

Location

MeSH Terms

Conditions

Systemic Vasculitis; Spondylarthropathies; Arthritis, Psoriatic; Scleroderma, Diffuse; Polymyalgia Rheumatica; Arthritis, Juvenile; Arthritis; Giant Cell Arteritis; Herpes Zoster

Interventions

Vaccination

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Scleroderma, Systemic; Connective Tissue Diseases; Muscular Diseases; Rheumatic Diseases; Autoimmune Diseases; Immune System Diseases; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Arteritis; Skin Diseases, Vascular; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patients with different rheumatic diseases receiving different immunosuppressive treatments (active group) and patients with different rheumatic diseases without immunosuppressive treatment (control) receive 2 doses of subunit vaccine against herpes zoster (Shingrix). Vaccine response between the two groups will be compared

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 8, 2025
• Study Start: December 17, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 30, 2034
• Last Updated: January 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after the study completition

Locations

SE (1)