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

NCT07252804 | Recruiting Phase 4

• 1 other identifier: 761245237 0000 0068
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 2

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.

Conditions

Autoimmune Rheumatologic Disease

Keywords

Meningococcal B vaccine; Autoimmune Rheumatic Diseases; Rheumatology; Pediatric Rheumatology; Infectious Disease Prevention

Outcome Measures

Primary Outcomes (1)

• Seroconversion Rate After Vaccination

  Proportion of participants who achieve seroconversion. The humoral response rate induced by the vaccine, or seroconversion, will be defined by the bactericidal titer (the dilution resulting in 50% bacterial killing within 60 minutes compared to the control). Titers ≥ 1:4 will be considered bactericidal. The geometric mean titer will be calculated using the exponential of the mean of log-transformed concentrations.

  Day 28 to Day 208

Secondary Outcomes (7)

• Influence of Immunosuppressive Treatment on the response to MenB-4C vaccination

  Day 28 to Day 208

• Impact of MenB-4C vaccination on Disease Activity on patients with JIA

  Day 1 through D56

• Impact of MenB-4C vaccination on Disease Activity on patients with JSLE

  Day 1 through Day 56

• Impact of MenB-4c vaccination on Disease Activity on patients with JDM

  Day 1 through Day 56

• Number of patients with adverse events related to the vaccination with MenB-4C

  Day 1 through Day 56

Study Arms (2)

J-ARDs

EXPERIMENTAL

Patients with ARDs will receive 2 doses (0.5 mL each) of Bexsero, 1 month apart

Biological: Meningococcal B (Bexsero)

Control

ACTIVE COMPARATOR

Healthy participants will receive 2 doses (0.5 mL each) of Bexsero, 1 month apart

Biological: Meningococcal B (Bexsero)

Interventions

Meningococcal B (Bexsero) BIOLOGICAL

The MenB-4C vaccine consists of three recombinant antigenic proteins: Neisseria meningitidis Neisseria adhesin A (NadA), factor H binding protein subfamily B (FHbp-B), and Neisseria heparin-binding antigen (NHBA), along with outer membrane vesicles (OMVs) expressing porin A (PorA) protein from serosubtype P1.4. The MenB-4C vaccine will be administered intramuscularly (into the deltoid muscle) in 2 doses of 0.5 mL each, one month apart.

Also known as: MenB-4C

Control; J-ARDs

Eligibility Criteria

• Age: 2 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Transfusion of blood products within 6 months prior to the study;
• Application of any vaccine within one month prior to each dose.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Insituto Adolfo Lutz: collaborator

Study Sites (2)

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

Related Publications (4)

• Perez-Vilar S, Dores GM, Marquez PL, Ng CS, Cano MV, Rastogi A, Lee L, Su JR, Duffy J. Safety surveillance of meningococcal group B vaccine (Bexsero(R)), Vaccine Adverse Event Reporting System, 2015-2018. Vaccine. 2022 Jan 21;40(2):247-254. doi: 10.1016/j.vaccine.2021.11.071. Epub 2021 Dec 7.

  PMID: 34887130 BACKGROUND

• Flacco ME, Manzoli L, Rosso A, Marzuillo C, Bergamini M, Stefanati A, Cultrera R, Villari P, Ricciardi W, Ioannidis JPA, Contopoulos-Ioannidis DG. Immunogenicity and safety of the multicomponent meningococcal B vaccine (4CMenB) in children and adolescents: a systematic review and meta-analysis. Lancet Infect Dis. 2018 Apr;18(4):461-472. doi: 10.1016/S1473-3099(18)30048-3. Epub 2018 Jan 19.

  PMID: 29371070 BACKGROUND

• Singh JA, Cleveland JD. Hospitalized Infections in Lupus: A Nationwide Study of Types of Infections, Time Trends, Health Care Utilization, and In-Hospital Mortality. Arthritis Rheumatol. 2021 Apr;73(4):617-630. doi: 10.1002/art.41577. Epub 2021 Mar 5.

  PMID: 33142044 BACKGROUND

• Safadi MA, O'Ryan M, Valenzuela Bravo MT, Brandileone MC, Gorla MC, de Lemos AP, Moreno G, Vazquez JA, Lopez EL, Taha MK, Borrow R; Global Meningococcal Initiative. The current situation of meningococcal disease in Latin America and updated Global Meningococcal Initiative (GMI) recommendations. Vaccine. 2015 Nov 27;33(48):6529-36. doi: 10.1016/j.vaccine.2015.10.055. Epub 2015 Oct 25.

  PMID: 26597036 BACKGROUND

MeSH Terms

Interventions

4CMenB vaccine

Central Study Contacts

Clovis A Silva, Full Professor

CONTACT

11 2661-6570; reumatologia.fmusp@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: November 28, 2025
• Study Start: February 19, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)