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(Referência obtida automaticamente do Web of Science, por meio da informação sobre o financiamento pela FAPESP e o número do processo correspondente, incluída na publicação pelos autores.)

Immunogenicity and safety of the 2009 non-adjuvanted influenza A/H1N1 vaccine in a large cohort of autoimmune rheumatic diseases

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Autor(es):
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Saad, Carla G. S. [1] ; Borba, Eduardo F. [1] ; Aikawa, Nadia E. [1, 2] ; Silva, Clovis A. [1, 2] ; Pereira, Rosa M. R. [1] ; Calich, Ana Luisa [1] ; Moraes, Julio C. B. [1] ; Ribeiro, Ana C. M. [1] ; Viana, Vilma S. T. [1] ; Pasoto, Sandra G. [1] ; Carvalho, Jozelio F. [1] ; Franca, Ivan L. A. [3] ; Guedes, Lissiane K. N. [1] ; Shinjo, Samuel K. [1] ; Sampaio-Barros, Percival D. [1] ; Caleiro, Maria T. [1] ; Goncalves, Celio R. [1] ; Fuller, Ricardo [1] ; Levy-Neto, Mauricio [1] ; Timenetsky, Maria do Carmo S. [4] ; Precioso, Alexander R. [5] ; Bonfa, Eloisa [1]
Número total de Autores: 22
Afiliação do(s) autor(es):
[1] Univ Sao Paulo, Fac Med, Disciplina Reumatol, Div Rheumatol, BR-05403010 Sao Paulo - Brazil
[2] Univ Sao Paulo, Fac Med, Disciplina Reumatol, Pediat Rheumatol Unit, BR-05403010 Sao Paulo - Brazil
[3] Univ Sao Paulo, Fac Med, Disciplina Reumatol, Div Infect Dis, BR-05403010 Sao Paulo - Brazil
[4] Univ Sao Paulo, Fac Med, Inst Adolfo Lutz, BR-05403010 Sao Paulo - Brazil
[5] Fundacao Butantan, Inst Butantan, Sao Paulo - Brazil
Número total de Afiliações: 5
Tipo de documento: Artigo Científico
Fonte: ANNALS OF THE RHEUMATIC DISEASES; v. 70, n. 6, p. 1068-1073, JUN 2011.
Citações Web of Science: 51
Resumo

Background Despite the WHO recommendation that the 2010-2011 trivalent seasonal flu vaccine must contain A/California/7/2009/H1N1-like virus there is no consistent data regarding its immunogenicity and safety in a large autoimmune rheumatic disease (ARD) population. Methods 1668 ARD patients (systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic sclerosis, psoriatic arthritis (PsA), Behcet's disease (BD), mixed connective tissue disease, primary antiphospholipid syndrome (PAPS), dermatomyositis (DM), primary Sjogren's syndrome, Takayasu's arteritis, polymyositis and Granulomatosis with polyangiitis (Wegener's) (GPA)) and 234 healthy controls were vaccinated with a non-adjuvanted influenza A/California/7/2009(H1N1) virus-like strain flu. Subjects were evaluated before vaccination and 21 days post-vaccination. The percentage of seroprotection, seroconversion and the factor increase in geometric mean titre (GMT) were calculated. Results After immunisation, seroprotection rates (68.5% vs 82.9% p < 0.0001), seroconversion rates (63.4% vs 76.9%, p < 0.001) and the factor increase in GMT (8.9 vs 13.2 p < 0.0001) were significantly lower in ARD than controls. Analysis of specific diseases revealed that seroprotection significantly reduced in SLE (p < 0.0001), RA (p < 0.0001), PsA (p=0.0006), AS (p=0.04), BD (p=0.04) and DM (p=0.04) patients than controls. The seroconversion rates in SLE (p < 0.0001), RA (p < 0.0001) and PsA (p=0.0006) patients and the increase in GMTs in SLE (p < 0.0001), RA (p < 0.0001) and PsA (p < 0.0001) patients were also reduced compared with controls. Moderate and severe side effects were not reported. Conclusions The novel recognition of a diverse vaccine immunogenicity profile in distinct ARDs supports the notion that a booster dose may be recommended for diseases with suboptimal immune responses. This large study also settles the issue of vaccine safety. (ClinicalTrials.gov \#NCT01151644) (AU)

Processo FAPESP: 10/10749-0 - Vacina anti-influenza H1N1/2009 em pacientes com doenças reumáticas autoimunes
Beneficiário:Eloisa Silva Dutra de Oliveira Bonfá
Linha de fomento: Auxílio à Pesquisa - Regular