Can the shingles vaccine protect those with autoimmune conditions?
NCT ID NCT07280741
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether the shingles vaccine (RZV) works and is safe for adults with autoimmune rheumatic diseases like rheumatoid arthritis or lupus who are taking immune-suppressing drugs. Two hundred participants will receive two doses of the vaccine. Researchers will measure antibody levels and track shingles cases to see if the vaccine provides protection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Recombinant Zoster Vaccine (Shingrix)
- What this could lead to
- If successful, this could show that the shingles vaccine is effective and safe for people with autoimmune rheumatic diseases on immunomodulators, helping prevent a painful condition.
- What could go wrong
- This is a phase 4 trial with 200 participants, so results may not apply to everyone. The vaccine might be less effective in people on certain immune-suppressing drugs, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital das Clínicas
RECRUITINGSão Paulo, São Paulo, 05403-010, Brazil
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