Article Text

PDF
Extended report
Immunogenicity and safety of the 2009 non-adjuvanted influenza A/H1N1 vaccine in a large cohort of autoimmune rheumatic diseases
  1. Carla G S Saad1,
  2. Eduardo F Borba1,
  3. Nadia E Aikawa1,2,
  4. Clovis A Silva1,2,
  5. Rosa M R Pereira1,
  6. Ana Luisa Calich1,
  7. Julio C B Moraes1,
  8. Ana C M Ribeiro1,
  9. Vilma S T Viana1,
  10. Sandra G Pasoto1,
  11. Jozelio F Carvalho1,
  12. Ivan L A França3,
  13. Lissiane K N Guedes1,
  14. Samuel K Shinjo1,
  15. Percival D Sampaio-Barros1,
  16. Maria T Caleiro1,
  17. Celio R Goncalves1,
  18. Ricardo Fuller1,
  19. Mauricio Levy-Neto1,
  20. Maria do Carmo S Timenetsky4,
  21. Alexander R Precioso5,
  22. Eloisa Bonfa1
  1. 1Division of Rheumatology, Faculdade de Medicina da Universidade de São Paulo-Disciplina de Reumatologia, Sao Paulo, Brazil
  2. 2Pediatric Rheumatology Unit, Faculdade de Medicina da Universidade de São Paulo-Disciplina de Reumatologia, Sao Paulo, Brazil
  3. 3Division of Infectious Diseases, Faculdade de Medicina da Universidade de São Paulo-Disciplina de Reumatologia, Sao Paulo, Brazil
  4. 4Instituto Adolfo Lutz of Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, Brazil
  5. 5Instituto Butantan—Fundação Butantan, Sao Paulo, Brazil
  1. Correspondence to Eloisa Bonfa, Faculdade de Medicina da Universidade de São Paulo-Disciplina de Reumatologia, Av Dr Arnaldo, 455, 3° andar, sala 3190, Cerqueira César, Sao Paulo SP 05403-010, Brazil; ebonfa{at}lim17.fm.usp.br

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 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)

Statistics from Altmetric.com

Footnotes

  • Ethics approval This study was conducted with the approval of the Cappesq.

  • Provenance and peer review Not commissioned; externally peer reviewed.

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.