NCT07252804 Immunogenicity and Safety of MenB Vaccine in Pediatric Patients With Autoimmune Rheumatic Diseases
| NCT ID | NCT07252804 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Autoimmune Rheumatologic Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 263 participants |
| Start Date | 2026-02-19 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 263 participants in total. It began in 2026-02-19 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 disease activity index 2000 (SLEDAI-2K) (CBC, anti-dsDNA, complement, urinalysis, protein/creatinine ratio) * Juvenile Idiopatic Arthritis (JIA): Juvenile Arthritis Disease Activity Score (JADAS) (ESR, CRP) * Juvenile dermatomyositis (JDM): Manual Muscle Testing (MMT) e Childhood Myositis Assessment Scale (CMAS): (CPK, transaminases, LDH) Researcher will also perform analysis in: Humoral immunogenicity will be assessed using serum bactericidal activity (SBA) assay with exogenous complement (baby rabbit, Pel Freez) against four test strains: H44/76 (fHBP), 5/99 (NadA), NZ98/254 (PorA), and M10713 (NHBA), from blood samples collected at D0, D28, D56, and D208. SBA assays will be conducted at the Immunology Center of the Adolfo Lutz Institute, São Paulo. Exogenous complement will be added to serially diluted serum samples, followed by the addition of a bacterial suspension. The humoral response rate induced by the vaccine, or seroconversion, will be defined by the bactericidal titer (the dilution that results in 50% bacterial killing within 60 minutes compared to the control), with titers ≥ 1:4 considered bactericidal. The geometric mean titers will be calculated using the exponential of the mean of the log-transformed concentrations. Immunosuppressive treatments (NSAIDs, prednisone/prednisolone, intra-articular steroids, hydroxychloroquine, methotrexate, azathioprine, leflunomide, cyclosporine, tacrolimus, mycophenolate mofetil, and biologics \[anti-TNF, tocilizumab, abatacept, belimumab, rituximab\]) will be recorded sistematicaly. Physical activity levels will be assessed using validated, age-appropriate methods.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07252804 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 25 Years, studying Autoimmune Rheumatologic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07252804 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07252804 currently recruiting?
Yes, NCT07252804 is actively recruiting participants. Contact the research team at reumatologia.fmusp@hc.fm.usp.br for enrollment information.
Where is the NCT07252804 trial being conducted?
This trial is being conducted at São Paulo, Brazil, São Paulo, Brazil.
Who is sponsoring the NCT07252804 clinical trial?
NCT07252804 is sponsored by University of Sao Paulo General Hospital. The trial plans to enroll 263 participants.