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Can the MenB vaccine protect kids with rheumatic conditions?

NCT ID NCT07252804

Vaccine 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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing the meningococcal B vaccine (Bexsero) in children and young adults aged 2 to 25 who have autoimmune rheumatic diseases like juvenile arthritis or lupus. Researchers want to see if the vaccine triggers a strong immune response and if it is safe, especially for those on immune-suppressing medications. Participants will receive two vaccine doses one month apart, with blood tests to measure protection over a year.

What this could mean

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

Active substance
Meningococcal B vaccine (Bexsero)
What this could lead to
If successful, this could show that the meningococcal B vaccine is safe and effective for children with autoimmune rheumatic diseases, helping protect them from serious infection.
What could go wrong
This is a phase 4 study, so the vaccine is already approved. However, immune-suppressing treatments may reduce vaccine effectiveness, and the trial is relatively small (263 participants), so results may not apply to everyone.

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 263 people

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

Started

Feb 2026

Expected to finish

Dec 2027

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

2 to 25 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: * Participants must be between 2 and 25 years of age with no prior history of MenB-4C vaccination. * Patients classified with autoimmune rheumatic diseases will be invited to participate. Patients with JIA must meet the classification criteria of the International League of Associations for Rheumatology; patients with JSLE, the American College of Rheumatology criteria; and those with JDM, the Bohan \& Peter criteria. Exclusion Criteria: * History of any reaction or hypersensitivity to any vaccine component; * Acute infectious disease and/or fever at the time of vaccination; * Pregnancy or breastfeeding; * History of Guillain-Barré syndrome; * Participants who fail to attend evaluation visits and laboratory sample collection; hospitalization at study inclusion; * Transfusion of blood products within 6 months prior to the study; * Application of any vaccine within one month prior to each dose.

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Conditions

The condition(s) this trial relates to.

juvenile dermatomyositis juvenile idiopathic arthritis pediatric systemic lupus erythematosus

As listed by the trial registrant

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

Autoimmune rheumatologic disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Rheumatology Division, Faculdade de Medicina da USP

    RECRUITING

    São Paulo, São Paulo, Brazil

  • University of São Paulo General Hospital

    RECRUITING

    São Paulo, São Paulo, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.