Condition: Autoimmune Rheumatologic Disease · Sponsor: University of Sao Paulo General Hospital
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 immediately before vaccination at the baseline visit (D0), then receive the first vaccine dose on the same day (D0). The second dose will be administered 4 weeks after the first dose (D28). Blood samples will be collected on D0, D28, and D56. A final sample will be collected one year after the last dose (D208) to evaluate the persistence of immune response. At study entry and one month after each dose, patients will also be assessed for clinical and laboratory disease activity using disease-specific indices and scores. * Juvenile Systemic lupus erythematosus (JSLE): Systemic lupus erythematosus disea…
This description comes directly from the study's public registry record.
Clovis A Silva, Full Professor · 11 2661-6570 · reumatologia.fmusp@hc.fm.usp.br
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT07252804