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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital das Clínicas
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Eloisa Bonfa, Full Professor
• Email: eloisa.bonfa@hc.fm.usp.br
• Phone: +55 11 3061-7492

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Preventing HSV flares in people with autoimmune rheumatic diseases

  This trial tests whether taking acyclovir every day for a year can reduce herpes simplex recurrences in people with autoimmune rheumatic diseases who have a history of frequent HSV episodes.

  Recruiting Phase 4 University of Sao Paulo General Hospital · São Paulo, São Paulo · NCT07341386

• Antibiotic Prophylaxis Before Simple Tooth Extraction in Immunosuppressed Patients with Autoimmune Rheumatic Diseases

  This trial tests whether giving a single dose of amoxicillin before a simple tooth extraction can prevent infections in adults with autoimmune rheumatic diseases who are on immunosuppressive therapy.

  Recruiting Phase 4 University of Sao Paulo General Hospital · São Paulo, São Paulo · NCT07275580

• Discontinuing Methotrexate for 2 Weeks After PCV20 to See If Immunity Improves

  This trial tests whether stopping methotrexate for two weeks after the PCV20 vaccine helps adults with autoimmune rheumatic diseases develop a stronger immune response.

  Recruiting Phase 4 University of Sao Paulo General Hospital · São Paulo, São Paulo · NCT07242092

• Preventive treatment for pneumonia in patients with autoimmune diseases

  This study is testing if a common antibiotic can help prevent a specific type of pneumonia in people with autoimmune diseases.

  Recruiting Phase 4 Tongji Hospital · Wuhan, Hubei · NCT06499233

• Combined e-Learning and Virtual Reality Training to Improve Rheumatology Provider Communication

  This trial tests whether a combined online course and VR training helps rheumatology providers communicate better with patients and whether patients rate their communication more highly after training.

  Recruiting Leiden University Medical Center · Leiden, South Holland · NCT07835256

• Pain patterns in rheumatic diseases: see if pain works differently in patients and healthy people

  This observational study tests how pain is experienced and measured in people with rheumatic diseases compared with healthy volunteers.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07829497

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.