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Vaccine
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doi:10.1016/j.vaccine.2011.11.083 | How to Cite or Link Using DOI
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Immunogenicity, safety and tolerability of MF59-adjuvanted seasonal influenza vaccine in children with juvenile idiopathic arthritis
Laura Dell?Era, Fabrizia Corona, Cristina Daleno, Alessia Scala, Nicola Principi, Susanna Esposito Corresponding Author Contact Information, E-mail The Corresponding Author
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Department of Maternal and Pediatric Sciences, Universit? degli Studi di Milano, Fondazione IRCCS Ca? Granda Ospedale Maggiore Policlinico, Via Commenda 9, 20122 Milano, Italy
Received 9 October 2011; revised 1 November 2011; Accepted 21 November 2011. Available online 2 December 2011.
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.
Highlights
► MF59-seasonal influenza vaccine was studied in juvenile idiopathic arthritis (JIA). ► A reduced immunogenicity was observed in the etanercept-treated pediatric patients. ► Immunogenicity was similar in the DMARD-treated JIA patients and healthy controls. ► Safety and tolerability of the vaccine appeared to be good even in presence of JIA.
http://www.sciencedirect.com/science/article/pii/S0264410X11018792
In Press, Uncorrected Proof - Note to users
doi:10.1016/j.vaccine.2011.11.083 | How to Cite or Link Using DOI
Permissions & Reprints
Immunogenicity, safety and tolerability of MF59-adjuvanted seasonal influenza vaccine in children with juvenile idiopathic arthritis
Laura Dell?Era, Fabrizia Corona, Cristina Daleno, Alessia Scala, Nicola Principi, Susanna Esposito Corresponding Author Contact Information, E-mail The Corresponding Author
Purchase
Department of Maternal and Pediatric Sciences, Universit? degli Studi di Milano, Fondazione IRCCS Ca? Granda Ospedale Maggiore Policlinico, Via Commenda 9, 20122 Milano, Italy
Received 9 October 2011; revised 1 November 2011; Accepted 21 November 2011. Available online 2 December 2011.
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.
Highlights
► MF59-seasonal influenza vaccine was studied in juvenile idiopathic arthritis (JIA). ► A reduced immunogenicity was observed in the etanercept-treated pediatric patients. ► Immunogenicity was similar in the DMARD-treated JIA patients and healthy controls. ► Safety and tolerability of the vaccine appeared to be good even in presence of JIA.
http://www.sciencedirect.com/science/article/pii/S0264410X11018792