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Shingles vaccine trial aims to protect vulnerable patients

NCT ID NCT05879419

Prevention Sponsor: University of Sao Paulo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests the Shingrix vaccine in over 2,000 adults with autoimmune rheumatic diseases like rheumatoid arthritis and lupus, who are at higher risk for shingles. Researchers will compare vaccinated patients to unvaccinated ones to see if the vaccine is safe and triggers a strong immune response. The goal is to prevent shingles without worsening the underlying rheumatic condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Recombinant Herpes Zoster Vaccine (Shingrix)
What this could lead to
If successful, this could show that the Shingrix vaccine is safe and effective for people with autoimmune rheumatic diseases, reducing their high risk of shingles.
What could go wrong
This is an early-stage study in a specific patient group, and results may not apply to all. The vaccine could cause flares or have reduced effectiveness due to immunosuppression.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 2,005 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Jun 2032

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * All subjects will be adults (≥18 years-old). * ARD patients will be selected from patients regularly followed up at the Outpatient Rheumatology Clinics of the Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil, according to the specific classification criteria: RA (Aletaha et al., 2010), SLE (Petri et al., 2012), pSS (Vitali et al., 2002), SSc (van den Hoogen et al., 2013), IIM (Lundberg et al., 2017), axial spondyloarthritis (axSpA) (Rudwaleit et al., 2009), PsA (Tillett et al., 2012) and granulomatosis with polyangiitis (Leavitt et al., 1990). * Patients must be under current use of cyclophosphamide, mycophenolate mofetil, azathioprine, cyclosporin, tacrolimus, leflunomide, glucocorticoids, methotrexate, biologic therapy or JAKi with or without csDMARDs for at least one month prior to study inclusion. Exclusion Criteria: * history of any reaction or hypersensitivity to any component of the vaccine; * previous HZ vaccination; * any occurrence of Guillain-Barré syndrome; * hospitalization, acute infectious disease or fever at the time of vaccination; * pregnancy or lactation at the time of vaccination; * history of HZ within the 12 months preceding the first dose of study vaccine; * people living with HIV/AIDS (PLWHA).

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Conditions

The condition(s) this trial relates to.

acquired idiopathic inflammatory myopathy ankylosing spondylitis Behcet disease dermatomyositis granulomatosis with polyangiitis juvenile dermatomyositis juvenile idiopathic arthritis myositis disease psoriatic arthritis rheumatoid arthritis Sjogren syndrome Spondylarthritis spondyloarthropathy systemic lupus erythematosus systemic sclerosis Systemic Vasculitis vasculitis herpes zoster prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Behçet disease Dermatomyositis, juvenile Idiopathic inflammatory myopathies Juvenile idiopathic arthritis Rheumatoid arthritis Sjogren's syndrome Spondylitis, ankylosing Spondyloarthritis Systemic lupus erythematosus Systemic sclerosis Vasculitis, systemic

Contacts and locations

Locations

  • Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo

    São Paulo, São Paulo, 05403-000, Brazil

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