BridgeMD
New treatment option for Autoimmune Rheumatic Diseases
Official title Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases Under Immunomodulators
ClinicalTrials.gov ID: NCT07280741
What this study is testing
What is Recombinant Zoster Vaccine (RZV)?
Recombinant Zoster Vaccine (RZV) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for autoimmune rheumatic diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults aged 18 years or older.
- Diagnosis of an autoimmune rheumatic disease (such as rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, psoriatic...
- Clinical stability at the time of enrollment, defined as no change in disease-modifying therapy or corticosteroid dose in the preceding four weeks...
- Current use of hydroxychloroquine or sulfasalazine in monotherapy for at least three months prior to inclusion.
- Can be under prednisone use of 5mg/week.
You likely can't join if
- 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...
- Use of glucocorticoids \>5mg/week.
- Acute febrile illness or active infection at the time of vaccination.
- Pregnancy or breastfeeding.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.