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Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases Under Immunomodulators

Study acronym: IMUNO-RZV
StatusRecruiting
PhasePhase 4
Started2025-12-02
View on ClinicalTrials.gov ↗

Amendment history

2026-03-06
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-12-03→confirmed 2025-12-02
Study sites0→1
Secondary endpoints5 to 8 entries
Disease safety (flare) in- ARDRheumatoid patientsArthritis Disease immunizedsafety with(flare) RZV- Systemic Lupus Erythematosus Disease safety (flare) - Ankylosing Spondylitis Disease safety (flare) - Sjögren's Syndrome
2025-12-01
Original filing
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.
Trial Details
NCT Number NCT07280741
Lead Sponsor University of Sao Paulo General Hospital
Conditions Autoimmune Rheumatic Diseases
Enrollment 200 participants
Start Date 2025-12-02
Primary Completion 2027-07-30 (estimated)
Study Completion 2028-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-11