Clinical Trial

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

Study acronym: IMUNO-RZV
Recruiting Phase 4
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-01.
Status change: Not Yet Recruiting → Recruiting 2026-03-06
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