Pandemic non-adjuvanted influenza A H1N1 vaccine in a cohort of patients with systemic sclerosis

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dc.contributor Sistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.author SAMPAIO-BARROS, Percival D. FMUSP-HC
ANDRADE, Danieli C. O. FMUSP-HC
SEGURO, Luciana C. P. FMUSP-HC
PASOTO, Sandra G. FMUSP-HC
VIANA, Vilma S. T. FMUSP-HC
RIBEIRO, Ana C. M. FMUSP-HC
AIKAWA, Nadia E. FMUSP-HC
TIMENETSKY, Maria do Carmo S.
PRECIOSO, Alexander R.
SILVA, Clovis A. FMUSP-HC
BONFA, Eloisa FMUSP-HC
dc.date.issued 2018
dc.identifier.citation RHEUMATOLOGY, v.57, n.10, p.1721-1725, 2018
dc.identifier.issn 1462-0324
dc.identifier.uri http://observatorio.fm.usp.br/handle/OPI/29528
dc.description.abstract Objective. To assess the possible effect of therapy, disease subtype and severity on H1N1 immunogenicity in patients with SSc. Methods. Ninety-two patients and 92 age- and gender-matched healthy controls received adjuvant-free influenza A/California/7/2009 (pH1N1) vaccine. Blood samples were collected immediately before and 3 weeks after vaccination to evaluate antibody responses to the H1N1 virus. Efficacy was assessed by seroprotection (SP) and seroconversion (SC) rates and the factor increase in geometric mean antibody titre. Participants received a 21-day symptom diary card and were instructed to report local and systemic adverse events. Results. SSc patients were predominantly females (91 %) and 61 % had limited SSc, 12% had severe skin involvement and 57.6% were on immunosuppressive (IS) therapy. SSc patients and controls presented comparable overall SP (P=0.20) and SC (P=0.61) rates. Further evaluation of the possible effect of disease and therapy revealed similar rates of SP and SC in patients with dcSSc vs IcSSc (SP P =0.62 and SC P = 0.66), severe vs mild/moderate skin involvement (SP P=1 and SC P = 0.45) and with vs without IS (SP P = 0.26 and SC P=0.10). The frequency of mild local and minor systemic reactions was similar in patients with dcSSC vs IcSSc (P =0.70 vs 0.32) and in those with and without severe skin involvement (P = 0.59 vs 0.28). Conclusion. The non-adjuvanted influenza H1N1 virus vaccine proved to be safe and effective, independent of SSc clinical subtype, disease severity or therapy. These latter factors do not seem to contribute to mild adverse events observed in SSc. Our data support the annual influenza vaccination recommendation for these patients.
dc.description.sponsorship · Fundacao de Amparo a Pesquisa do Estado de Sao Paulo (FAPESP) [2010/10749-0]
· Conselho Nacional de Desenvolvimento Cientifico e Tecnologico (CNPQ) [303422/2015-7, 3053068/2014]
· Butantan Foundation
dc.language.iso eng
dc.publisher OXFORD UNIV PRESS
dc.relation.ispartof Rheumatology
dc.rights restrictedAccess
dc.subject systemic sclerosis; scleroderma; influenza; vaccine; pandemic influenza A H1N1; non-adjuvanted influenza vaccine
dc.subject.other eular scleroderma trials; recommendations; immunogenicity; diseases; safety; eustar; drugs; death
dc.title Pandemic non-adjuvanted influenza A H1N1 vaccine in a cohort of patients with systemic sclerosis
dc.type article
dc.rights.holder Copyright OXFORD UNIV PRESS
dc.description.group LIM/03
dc.description.group LIM/17
dc.description.group LIM/36
dc.identifier.doi 10.1093/rheumatology/kex330
dc.identifier.pmid 28968874
dc.type.category original article
dc.type.version publishedVersion
hcfmusp.author SAMPAIO-BARROS, Percival D.:HC:ICHC
hcfmusp.author ANDRADE, Danieli C. O.:HC:ICHC
hcfmusp.author SEGURO, Luciana C. P.:HC:ICHC
hcfmusp.author PASOTO, Sandra G.:FM:
hcfmusp.author VIANA, Vilma S. T.:HC:ICHC
hcfmusp.author RIBEIRO, Ana C. M.:HC:ICHC
hcfmusp.author AIKAWA, Nadia E.:HC:ICHC
hcfmusp.author SILVA, Clovis A.:FM:MPE
hcfmusp.author BONFA, Eloisa:FM:MCM
hcfmusp.author.external · TIMENETSKY, Maria do Carmo S.:Inst Butantan, Dept Virol, Sao Paulo, Brazil
· PRECIOSO, Alexander R.:Inst Butantan, Lab Clin Trials & Pharmacovigilance, Sao Paulo, Brazil
hcfmusp.origem.id WOS:000446090000006
hcfmusp.origem.id 2-s2.0-85048689624
hcfmusp.publisher.city OXFORD
hcfmusp.publisher.country ENGLAND
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dc.description.index MEDLINE
dc.identifier.eissn 1462-0332
hcfmusp.citation.scopus 4
hcfmusp.citation.wos 1
hcfmusp.affiliation.country Brasil


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