Recombinant shingles vaccine for adults with autoimmune rheumatic diseases on single immunomodulator therapy

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

This study will test whether two doses of the recombinant shingles vaccine produce strong, lasting antibody responses and are safe for adults with autoimmune rheumatic diseases who are taking a single immunomodulatory medication like hydroxychloroquine or sulfasalazine.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Sao Paulo General Hospital (Academic / other)
• Drugs / interventions: methotrexate, cyclophosphamide, prednisone
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT07280741 on ClinicalTrials.gov

What this trial studies

This Phase IV interventional study enrolls clinically stable adults with autoimmune rheumatic diseases who are on immunomodulatory monotherapy and administers two doses of the adjuvanted recombinant zoster vaccine (RZV). The primary immunogenicity measures are anti-glycoprotein E (anti-gE) antibody titers, including seroconversion rates and geometric mean titers measured six weeks after completing the vaccination schedule. The trial also measures persistence of antibody titers at one year and monitors the incidence of confirmed herpes zoster during follow-up to capture safety and real-world effectiveness. Participants must be stable on monotherapy (e.g., hydroxychloroquine or sulfasalazine) and able to attend clinic visits at the study site.

Who should consider this trial

Good fit: Adults (18+) with a diagnosed autoimmune rheumatic disease who are clinically stable and have been on hydroxychloroquine or sulfasalazine monotherapy for at least three months, and who may be on low-dose prednisone as specified, are ideal candidates.

Not a fit: People who have already received RZV, had herpes zoster or varicella within the prior 12 months, are on combination immunosuppressive therapy, or have recent disease flare or infection are unlikely to benefit from participation in this protocol.

Why it matters

Potential benefit: If successful, the results could show that RZV gives reliable and lasting protection against shingles for people with autoimmune rheumatic diseases on common single immunomodulators, helping guide vaccination advice.

How similar studies have performed: RZV has demonstrated strong efficacy and immunogenicity in older adults and several immunocompromised populations, but evidence specifically in autoimmune rheumatic disease patients on single immunomodulators is more limited.

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.

Where this trial is running

São Paulo, São Paulo

• Hospital das Clínicas — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Eloisa Bonfa, Full Professor

Conditions Autoimmune Rheumatic Diseases; Immunogenicity; Hepers Zoster; Vaccine; Safety; Immunomodulators; Inflammation