[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612378":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":28,"locations":35,"responsibleParty":60,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":27,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":38,"whyStopped":27,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"J-ARDs","EXPERIMENTAL","Patients with ARDs will receive 2 doses (0.5 mL each) of Bexsero, 1 month apart",[13],"Biological: Meningococcal B (Bexsero)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","Healthy participants will receive 2 doses (0.5 mL each) of Bexsero, 1 month apart",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Meningococcal B (Bexsero)","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.",[15,9],[26],"MenB-4C",null,[29],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Clovis A Silva, Full Professor","CONTACT","11 2661-6570","+55","reumatologia.fmusp@hc.fm.usp.br",[36,55],{"facility":37,"status":38,"city":39,"state":39,"zip":27,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Rheumatology Division, Faculdade de Medicina da USP","RECRUITING","São Paulo","Brazil","BR",{"type":43,"coordinates":44},"Point",[45,46],-46.63611,-23.5475,{"lat":46,"lon":45},[49,53],{"name":50,"role":31,"phone":51,"phoneExt":27,"email":52},"Clovis A Silva, Full professor","+55 11 2661-8806","clovis.silva@hc.fm.usp.br",{"name":54,"role":31,"phone":27,"phoneExt":27,"email":34},"Eloisa SDO Bonfa, Full Professor",{"facility":56,"status":38,"city":39,"state":39,"zip":27,"country":40,"countryCode":41,"cosmosGeoPoint":57,"geoPoint":59,"contacts":27},"University of São Paulo General Hospital",{"type":43,"coordinates":58},[45,46],{"lat":46,"lon":45},{"type":61,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[63],{"name":64,"class":65},"Insituto Adolfo Lutz","UNKNOWN","100612378","phase-4-immunogenicity-and-safety-of-menb-vaccine-in-pediatric-patients-with-autoimmune-rheumatic-diseases-100612378",false,"NCT07252804","Immunogenicity and Safety of MenB Vaccine in Pediatric Patients With Autoimmune Rheumatic Diseases","Short- and Long-Term Immunogenicity and Safety of Meningococcal Group B Vaccine in Children and Adolescents With Autoimmune Rheumatic Diseases","MENB-PARD","Inclusion Criteria:\n\n* Participants must be between 2 and 25 years of age with no prior history of MenB-4C vaccination.\n* Patients classified with autoimmune rheumatic diseases will be invited to participate.\n\nPatients 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.\n\nExclusion Criteria:\n\n* History of any reaction or hypersensitivity to any vaccine component;\n* Acute infectious disease and\u002For fever at the time of vaccination;\n* Pregnancy or breastfeeding;\n* History of Guillain-Barré syndrome;\n* Participants who fail to attend evaluation visits and laboratory sample collection; hospitalization at study inclusion;\n* Transfusion of blood products within 6 months prior to the study;\n* Application of any vaccine within one month prior to each dose.",true,"ALL","2 Years","25 Years",{"count":79,"type":80},263,"ESTIMATED","INTERVENTIONAL",[83],"PHASE4","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.\n\nThe main questions it aims to answer are:\n\n* To assess the influence of treatment on the response to the MenB-4C vaccine in patients with ARDs;\n* To evaluate the impact of the MenB-4C vaccine on disease activity in patients with ARDs;\n* To evaluate the safety of the MenB-4C vaccine in pediatric patients with ARDs and controls.\n* To evaluate the association between physical activity levels and immunogenicity after vaccination.\n\nParticipants will:\n\nReceive the MenB-4C vaccine (Bexsero©), administered intramuscularly in the deltoid muscle, in a 2-dose schedule (0.5 mL each), 1 month apart.\n\nAll 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.\n\nAt 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.\n\n* Juvenile Systemic lupus erythematosus (JSLE): Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) (CBC, anti-dsDNA, complement, urinalysis, protein\u002Fcreatinine ratio)\n* Juvenile Idiopatic Arthritis (JIA): Juvenile Arthritis Disease Activity Score (JADAS) (ESR, CRP)\n* Juvenile dermatomyositis (JDM): Manual Muscle Testing (MMT) e Childhood Myositis Assessment Scale (CMAS): (CPK, transaminases, LDH)\n\nResearcher will also perform analysis in:\n\nHumoral immunogenicity will be assessed using serum bactericidal activity (SBA) assay with exogenous complement (baby rabbit, Pel Freez) against four test strains: H44\u002F76 (fHBP), 5\u002F99 (NadA), NZ98\u002F254 (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.\n\nImmunosuppressive treatments (NSAIDs, prednisone\u002Fprednisolone, intra-articular steroids, hydroxychloroquine, methotrexate, azathioprine, leflunomide, cyclosporine, tacrolimus, mycophenolate mofetil, and biologics \\[anti-TNF, tocilizumab, abatacept, belimumab, rituximab\\]) will be recorded sistematicaly.\n\nPhysical activity levels will be assessed using validated, age-appropriate methods.",[86],"Autoimmune Rheumatologic Disease",[88,89,90,91,92],"Meningococcal B vaccine","Autoimmune Rheumatic Diseases","Rheumatology","Pediatric Rheumatology","Infectious Disease Prevention","2026-04-14",{"date":95,"type":96},"2026-04-20","ACTUAL",{"date":98,"type":96},"2026-02-19",{"date":100,"type":80},"2027-12-30",{"name":5,"class":6},2]