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AB0712 Long-term safety and immunogenicity of the pandemic unadjuvanted influenza A/H1N1 vaccine in primary sjÖgren’s syndrome
  1. S.G. Pasoto,
  2. A.C. Ribeiro,
  3. V.S. Viana,
  4. J.A. Barbosa,
  5. C. Bueno,
  6. M. Levy Neto,
  7. E. Bonfa
  1. Rheumatology, University of São Paulo, São Paulo, Brazil


Background Despite WHO recommendations about the A/California/7/2009/H1N1-like virus vaccination, there are no studies evaluating its possible influence on clinical manifestations and autoantibody profile in primary Sjögren’s syndrome (pSS).

Objectives To evaluate short/long-term safety and influence of influenza A/California/7/2009/H1N1-like virus vaccination on clinical manifestations and autoantibody profile in pSS.

Methods Thirty-six pSS patients and 36 gender/age-matched healthy controls were evaluated before and 21-days after vaccination with unadjuvanted influenza A/H1N1-like virus regarding seroprotection/seroconversion, factor increase in geometric mean titre (FI-GMT) and side effects. New onset of parotiditis, arthritis, vasculitis, pneumonitis or neurological disorders and autoantibody profile (ANA, RF, anti-dsDNA, Ro/SS-A/La/SS-B, alpha-fodrin, CCP, RNP/Sm, anticardiolipin) were assessed before, 21-days and 1-year of vaccination.

Results Patients and controls had similar rates of seroconversion (78 vs. 69%, p=0.42), seroprotection (83 vs. 72%, p=0.26) and FI-GMT (p=0.85). Disease duration, glucocorticoid (mean dose<10mg/day), methotrexate or azathioprine did not affect seroconversion (p>0.05). Interestingly, ANA positivity was more frequent in patients with seroconversion (100 vs. 71%, p=0.042). Regarding short-term side effects, only mild reactions were observed in comparable rates to controls (p>0.05). In the 1-year follow-up, the rate of new disease flares was similar to the previous year (11 vs.19%, p=0.51). Twenty-one days after vaccination, no change in the frequency or levels of autoantibodies was observed (p>0.05). Conversely, after 1-year, five patients developed positivity to anti-Ro/SS-A/La/SS-B, alpha-fodrin, CCP and/or IgM anticardiolipin. Of note, increase in titers only of anti-Ro and anti-La (p<0.001) was detected after 1-year.

Conclusions This is the first study to indicate appropriate influenza A/H1N1 vaccine safety and immunogenicity in pSS, reinforcing its recommendation. Further investigations are necessary to evaluate the clinical significance of long-term changes in autoantibody profile.

Disclosure of Interest S. Pasoto: None Declared, A. Ribeiro: None Declared, V. Viana: None Declared, J. Barbosa: None Declared, C. Bueno: None Declared, M. Levy Neto: None Declared, E. Bonfa Grant/Research support from: FAPESP grant: 2010/10749-0

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