title: Immunogenicity and safety of the 2009 non-adjuvanted influenza A/H1N1 vaccine in a large cohort of autoimmune rheumatic diseases.
abstract: 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), Behçet's disease (BD), mixed connective tissue disease, primary antiphospholipid syndrome (PAPS), dermatomyositis (DM), primary Sjögren'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
  /st> 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).
authors.affiliation: Division of Rheumatology, Faculdade de Medicina da Universidade de São Paulo-Disciplina de Reumatologia, Sao Paulo, Brazil.
authors.forename: Carla G S
authors.initials: CG
authors.lastname: Saad
authors.forename: Eduardo F
authors.initials: EF
authors.lastname: Borba
authors.forename: Nadia E
authors.initials: NE
authors.lastname: Aikawa
authors.forename: Clovis A
authors.initials: CA
authors.lastname: Silva
authors.forename: Rosa M R
authors.initials: RM
authors.lastname: Pereira
authors.forename: Ana Luisa
authors.initials: AL
authors.lastname: Calich
authors.forename: Julio C B
authors.initials: JC
authors.lastname: Moraes
authors.forename: Ana C M
authors.initials: AC
authors.lastname: Ribeiro
authors.forename: Vilma S T
authors.initials: VS
authors.lastname: Viana
authors.forename: Sandra G
authors.initials: SG
authors.lastname: Pasoto
authors.forename: Jozelio F
authors.initials: JF
authors.lastname: Carvalho
authors.forename: Ivan L A
authors.initials: IL
authors.lastname: França
authors.forename: Lissiane K N
authors.initials: LK
authors.lastname: Guedes
authors.forename: Samuel K
authors.initials: SK
authors.lastname: Shinjo
authors.forename: Percival D
authors.initials: PD
authors.lastname: Sampaio-Barros
authors.forename: Maria T
authors.initials: MT
authors.lastname: Caleiro
authors.forename: Celio R
authors.initials: CR
authors.lastname: Goncalves
authors.forename: Ricardo
authors.initials: R
authors.lastname: Fuller
authors.forename: Mauricio
authors.initials: M
authors.lastname: Levy-Neto
authors.forename: Maria do Carmo S
authors.initials: Mdo C
authors.lastname: Timenetsky
authors.forename: Alexander R
authors.initials: AR
authors.lastname: Precioso
authors.forename: Eloisa
authors.initials: E
authors.lastname: Bonfa
mesh_terms: D000276:Adjuvants, Immunologic; D000328:Adult; D000914:Antibodies, Viral / Q000096:biosynthesis; D001327:Autoimmune Diseases / Q000276:immunology*; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D007108:Immune Tolerance; D016867:Immunocompromised Host; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D012216:Rheumatic Diseases / Q000276:immunology*; D014611:Vaccination / Q000009:adverse effects / Q000379:methods; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines