title: Immunogenicity, safety and tolerability of MF59-adjuvanted seasonal influenza vaccine in children with juvenile idiopathic arthritis.
abstract: In order to evaluate the immunogenicity, safety, and tolerability of the MF-59 adjuvanted seasonal influenza vaccine in children and adolescents with juvenile idiopathic arthritis (JIA) treated with different anti-rheumatic drugs, 60 pediatric patients with JIA (30 treated with disease-modifying anti-rheumatic drugs [DMARDs] and 30 with etanercept) were compared with 30 healthy controls of similar gender and age. All of the patients received a single dose of the MF59-adjuvanted seasonal influenza vaccine (Fluad, Siena, Italy). Immunogenicity was assessed at baseline, and 1 and 3 months post-vaccination; safety and tolerability were also evaluated during the study period. The JIA patients treated with etanercept showed significantly lower geometric mean titres (GMTs) against the A/H1N1 strain than those treated with DMARDs (p<0.05) and the healthy controls (p<0.05), who had similar GMTs. The etanercept-treated JIA patients also showed a significant reduction in GMTs against the A/H1N1 and A/H3N2 strains from 1 to 3 months after vaccination (p<0.05). Furthermore, their seroconversion and seroprotection rates, and B antigen GMTs, were all significantly lower than those of the subjects in the other two groups (p<0.05). The safety and tolerability of the vaccine were good and similar between the groups. The results of this study indicate a reduced immune response to MF59-adjuvanted seasonal influenza vaccine in JIA children and adolescents treated with etanercept in comparison with those treated with DMARDs and healthy controls. The safety and tolerability of the vaccine appeared to be good in all of the study population.
authors.affiliation: Department of Maternal and Pediatric Sciences, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Commenda 9, 20122 Milano, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Dell'Era
authors.forename: Fabrizia
authors.initials: F
authors.lastname: Corona
authors.forename: Cristina
authors.initials: C
authors.lastname: Daleno
authors.forename: Alessia
authors.initials: A
authors.lastname: Scala
authors.forename: Nicola
authors.initials: N
authors.lastname: Principi
authors.forename: Susanna
authors.initials: S
authors.lastname: Esposito
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000293:Adolescent; D000914:Antibodies, Viral / Q000097:blood; D001171:Arthritis, Juvenile / Q000276:immunology*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology; D009981:Influenza B virus / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007558:Italy; D008297:Male; D011136:Polysorbates / Q000008:administration & dosage* / Q000009:adverse effects; D013185:Squalene / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D013185:Squalene