NCT07280741

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

Efficacy, Immunogenicity, and Safety of the Recombinant Herpes Zoster Vaccine (RZV) in Patients With Autoimmune Rheumatic Diseases Under Immunomodulators

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autoimmune Rheumatic Diseases

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Zoster Vaccine (RZV)	VRZ (Shingrix®) is composed of 50 μg of recombinant VZV glycoprotein E (gE) and the liposome-based AS01B (HZ/su) adjuvant system (containing 50 μg of 3-O-desacyl-4'-monophosphoryl lipid A \[MPL\] and 50 μg of Quillaja saponaria Molina, fraction 21 (QS21), licensed by GSK from Antigenics, a subsidiary of Agenus). Two doses of the vaccine will be administered (0.5 mL) into the deltoid muscle on days (D) 0 and D42.

Timeline

• Start date: 2025-12-02
• Primary completion: 2027-07-30
• Completion: 2028-07-30
• First posted: 2025-12-12
• Last updated: 2026-03-11

Locations

1 site across 1 country: Brazil