Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases Under Immunomodulators (IMUNO-RZV)

University of Sao Paulo General Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Autoimmune Rheumatic Diseases

Treatments: Biological: Recombinant Zoster Vaccine (RZV)

Study type: Interventional

Funder types: Other

Identifiers

NCT07280741

94187625300000068

Details and patient eligibility

About

This interventional phase IV clinical trial will evaluate the efficacy, immunogenicity and safety of the adjuvanted recombinant herpes zoster vaccine (RZV) in adults with autoimmune rheumatic diseases (ARDs) receiving immunomodulatory monotherapy. Humoral immune response will be quantified by anti-glycoprotein E (anti-gE) antibody titers. Patients will receive two doses of RZV. Outcomes include seroconversion and geometric mean titers six weeks after completion of the vaccination schedule, persistence of antibody titers at one year, and incidence of confirmed herpes zoster during follow-up.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18 years or older.
• Diagnosis of an autoimmune rheumatic disease (such as rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, psoriatic arthritis, systemic sclerosis, Sjögren syndrome, idiopathic inflammatory myopathies, or primary systemic vasculitis) according to validated classification criteria.
• Clinical stability at the time of enrollment, defined as no change in disease-modifying therapy or corticosteroid dose in the preceding four weeks and no evidence of infection or disease flare.
• Current use of hydroxychloroquine or sulfasalazine in monotherapy for at least three months prior to inclusion.
• Can be under prednisone use of 5mg/week.
• Ability and willingness to comply with study procedures and follow-up visits.
• Provision of written informed consent.

Exclusion criteria

• Previous vaccination with recombinant zoster vaccine (RZV).
• History of herpes zoster or varicella infection within 12 months before enrollment.
• Concomitant use of systemic immunosuppressive therapy including but not limited to methotrexate, mycophenolate mofetil, azathioprine, cyclophosphamide, biologics, or JAK inhibitors.
• Use of glucocorticoids >5mg/week.
• Acute febrile illness or active infection at the time of vaccination.
• Pregnancy or breastfeeding.
• Known hypersensitivity to any component of the recombinant zoster vaccine.
• History of Guillain-Barré syndrome.
• Any condition that, in the investigators' judgment, could interfere with study participation or interpretation of results.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Immunomodulator Monotherapy

Experimental group

Description:

Participants with autoimmune rheumatic diseases who are clinically stable and receiving monotherapy with hydroxychloroquine or sulfasalazine will receive two doses of the recombinant zoster vaccine (RZV, Shingrix) administered intramuscularly on Day 0 and Day 42. Immunogenicity will be evaluated through anti-glycoprotein E antibody titers at baseline, six weeks, and one year after vaccination. Safety, disease activity, and incidence of herpes zoster will be monitored throughout follow-up.

Treatment:

Biological: Recombinant Zoster Vaccine (RZV)