NCT07280741 Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases Under Immunomodulators
| NCT ID | NCT07280741 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Autoimmune Rheumatic Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-12-02 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2025-12-02 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07280741 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Autoimmune Rheumatic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07280741 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07280741 currently recruiting?
Yes, NCT07280741 is actively recruiting participants. Contact the research team at eloisa.bonfa@hc.fm.usp.br for enrollment information.
Where is the NCT07280741 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07280741 clinical trial?
NCT07280741 is sponsored by University of Sao Paulo General Hospital. The trial plans to enroll 200 participants.