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Immunogenicity and Safety of MenB Vaccine in Pediatric Patients With Autoimmune Rheumatic Diseases

RecruitingPhase 4Ages 2 Years - 25 YearsAllUniversity of Sao Paulo General Hospital
NCT07252804 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to evaluate the humoral immunogenicity of the meningococcal B vaccine (MenB-4C) in pediatric patients with autoimmune rheumatic diseases (ARDs), compared to age- and sex-matched non-immunosuppressed controls. The main questions it aims to answer are: * To assess the influence of treatment on the response to the MenB-4C vaccine in patients with ARDs; * To evaluate the impact of the MenB-4C vaccine on disease activity in patients with ARDs; * To evaluate the safety of the MenB-4C vaccine in pediatric patients with ARDs and controls. * To evaluate the association between physical activity levels and immunogenicity after vaccination. Participants will: Receive the MenB-4C vaccine (Bexsero©), administered intramuscularly in the deltoid muscle, in a 2-dose schedule (0.5 mL each), 1 month apart. All participants will have blood samples collected immediate

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📋 Eligibility rules (as published)
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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What it tests

  • Meningococcal B (Bexsero)
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Where

2 sites
Rheumatology Division, Faculdade de Medicina da USP
São Paulo, Brazil
University of São Paulo General Hospital
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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