Actively Recruiting

Phase 4
Age: 2Years - 25Years
All Genders
Healthy Volunteers
NCT07252804

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

Led by University of Sao Paulo General Hospital · Updated on 2026-04-20

263

Participants Needed

2

Research Sites

97 weeks

Total Duration

On this page

Sponsors

U

University of Sao Paulo General Hospital

Lead Sponsor

I

Insituto Adolfo Lutz

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Years - 25Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be between 2 and 25 years of age with no prior history of MenB-4C vaccination
  • Patients with autoimmune rheumatic diseases diagnosed by accepted criteria for juvenile idiopathic arthritis, juvenile systemic lupus erythematosus, or juvenile dermatomyositis
Not Eligible

You will not qualify if you...

  • History of allergic reaction or hypersensitivity to any MenB-4C vaccine components
  • Having an acute infection or fever at the time of vaccination
  • Being pregnant or breastfeeding
  • History of Guillain-Barré syndrome
  • Inability to attend study visits or provide required blood samples
  • Hospitalization at the time of study inclusion
  • Receiving blood transfusions within 6 months before the study
  • Having received any vaccine within one month prior to each study dose

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Rheumatology Division, Faculdade de Medicina da USP

São Paulo, São Paulo, Brazil

Actively Recruiting

2

University of São Paulo General Hospital

São Paulo, São Paulo, Brazil

Actively Recruiting

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Research Team

C

Clovis A Silva, Full Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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