Immunogenicity and safety of the meningococcal serogroup B vaccine in children and adolescents with autoimmune rheumatic diseases

• Grant number: 25/04251-5
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: May 01, 2025
• End date: April 30, 2026
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal Investigator: Clovis Artur Almeida da Silva
• Grantee: Ana Clara Silva Leão Praxedes
• Host Institution: Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
• Associated research grant: 22/12925-8 - Infection prevention strategies, mechanisms and factors that influence the response to interventions in patients with autoimmune rheumatic diseases, AP.TEM

Abstract

Invasive meningococcal disease (IMD), caused by Neisseria meningitidis, is a serious infection that can lead to death or cause significant sequelae, such as amputations, hearing loss, and neurological disorders. Serogroup B is responsible for 70% to 80% of cases in several countries, with a higher incidence in young children, adolescents, and young adults, especially in school and university settings.Patients with autoimmune rheumatic diseases (ARDs) are at greater risk of serious infections due to immunological alterations caused by the disease itself, the use of immunosuppressants, and the presence of comorbidities. Prevention through vaccination is therefore essential, especially among children, the age group most vulnerable to IMD.There are two vaccines licensed in Brazil against serogroup B: MenB-4C (Bexsero®) and MenB-FHbp (Trumenba®). MenB-4C is recommended for people aged 2 months and older, while MenB-FHbp is recommended for adolescents and young people aged 10 to 25. Both are not yet included in the National Immunization Program (PNI) due to their high cost.Studies have shown that the MenB-4C vaccine is immunogenic and safe in the general population, with a low incidence of serious adverse events (0.54%), the most common being pain at the injection site, fever, malaise and headache. Administration of paracetamol before and after vaccination helps to reduce fever without compromising the efficacy of the vaccine.In immunocompromised populations, the response to the MenB-4C vaccine varies. In patients with atypical hemolytic uremic syndrome, the efficacy was 50%, while in children with asplenia or complement deficiency, the response was comparable to that of healthy individuals, except in cases of complement deficiency, where it was lower.Despite evidence in other immunosuppressive conditions, there are still no specific studies evaluating the immunogenicity and safety of the MenB-4C vaccine in children and adolescents with autoimmune rheumatic diseases. The primary objective of the present project is to prospectively evaluate the humoral immunogenicity of the meningococcal vaccine (MenB-4C) in pediatric patients with ARD compared with non-immunosuppressed control individuals (CG) balanced by age and sex. Secondary objectives include the evaluation of the influence of short- and long-term immunosuppressive treatment on the response to the MenB-4C vaccine in patients with ARD, the evaluation of the impact of the MenB-4C vaccine on disease activity in patients with ARD, and the evaluation of the safety of the MenB-4C vaccine in pediatric patients with ARD and controls.