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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-03

Study Completion Date

2028-07-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Autoimmune Rheumatic Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Immunomodulator Monotherapy

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.

Group Type EXPERIMENTAL

Recombinant Zoster Vaccine (RZV)

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No