MenB (Bexsero) vaccine for children and young people with autoimmune rheumatic diseases

Short- and Long-Term Immunogenicity and Safety of Meningococcal Group B Vaccine in Children and Adolescents With Autoimmune Rheumatic Diseases

This project will test whether two doses of the MenB (Bexsero) vaccine produce protective antibody responses and are safe in children and young people (ages 2-25) with autoimmune rheumatic diseases compared with non-immunosuppressed peers.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 263 (estimated)
• Ages: 2 Years to 25 Years
• Sex: All
• Sponsor: University of Sao Paulo General Hospital (Academic / other)
• Drugs / interventions: tocilizumab, belimumab, rituximab, methotrexate, prednisone
• Locations: 2 sites (São Paulo, São Paulo and 1 other locations)
• Trial ID: NCT07252804 on ClinicalTrials.gov

What this trial studies

This Phase 4 interventional study enrolls participants aged 2-25 with autoimmune rheumatic diseases and age- and sex-matched non-immunosuppressed controls who have not previously received MenB-4C; all participants receive two intramuscular doses of MenB-4C (Bexsero) one month apart. Blood samples are collected at baseline and after vaccination to measure humoral immune responses, and physical activity levels will be recorded to explore associations with immunogenicity. Disease activity and adverse events are monitored to evaluate vaccine safety and any impact on the underlying rheumatic condition. The trial is conducted at the Rheumatology Division of the University of São Paulo General Hospital in São Paulo, Brazil.

Who should consider this trial

Good fit: Ideal candidates are 2- to 25-year-olds with a diagnosed autoimmune rheumatic disease who have not previously received MenB-4C and who can attend all in-person visits and blood draws.

Not a fit: Patients who are pregnant or breastfeeding, have an acute infection or fever at vaccination, a history of Guillain–Barré syndrome, recent blood transfusion, recent other vaccinations, known hypersensitivity to vaccine components, or inability to attend study visits would be excluded and are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could show that MenB-4C provides protective antibodies and is safe in young patients with autoimmune rheumatic diseases, supporting broader vaccination recommendations for this vulnerable group.

How similar studies have performed: MenB-4C (Bexsero) has demonstrated immunogenicity and safety in general pediatric populations across multiple studies and meta-analyses, but data specifically in pediatric patients with autoimmune rheumatic diseases are limited.

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.

Where this trial is running

São Paulo, São Paulo and 1 other locations

• 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)

Study contacts

• Study coordinator: Clovis A Silva, Full Professor

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