MenB (Bexsero) vaccine for children and young people with autoimmune rheumatic diseases

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 4 interventional study enrolls participants aged 2-25 with autoimmune rheumatic diseases and age- and sex-matched non-immunosuppressed controls who have not previously received MenB-4C; all participants receive two intramuscular doses of MenB-4C (Bexsero) one month apart. Blood samples are collected at baseline and after vaccination to measure humoral immune responses, and physical activity levels will be recorded to explore associations with immunogenicity. Disease activity and adverse events are monitored to evaluate vaccine safety and any impact on the underlying rheumatic condition. The trial is conducted at the Rheumatology Division of the University of São Paulo General Hospital in São Paulo, Brazil.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rheumatology Division, Faculdade de Medicina da USP
  São Paulo, São Paulo, Brazil Recruiting
• University of São Paulo General Hospital
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Clovis A Silva, Full Professor
• Email: reumatologia.fmusp@hc.fm.usp.br
• Phone: 11 2661-6570

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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.