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 in Behçet´s Disease (BD).
Objectives To evaluate short-term safety and efficacy of influenza A/California/7/2009/H1N1-like virus single vaccination and the potential deleterious effect of the vaccine in BD patients compared to healthy controls.
Methods Eighty-five BD patients and 85 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), C-reactive-protein (CRP) levels and side effects. Brazilian BD Current Activity Form (BR-BDCAF) was used to assess BD activity.
Results Seroconversion rate was significantly lower in BD patients compared to controls (69 vs. 83%, p=0.04). Similar rates of seroprotection (71 vs. 83%, p=0.06) and FI-GMT (p=0.96) were found. Interestingly, BD patients without seroconversion had significantly higher mean BR-BDCAF scores (6.0 ±4.1 vs. 3.8 ±4.3, p=0.009), with a significantly increased rate of active BD in this group after the vaccination (73 vs. 50%, p=0.003). Disease duration and glucocorticoid, immunosuppressors or TNF-blockers therapies did not affect seroconversion (p>0.05). Regarding side effects, patients had significantly increased rate of mild and transient reactions, such as fever (7 vs. 0%, p=0.02), headache, (27 vs. 12%, p=0.02), arthralgia (24 vs. 0.2%, p<0.001) and myalgia (25 vs. 9%, p=0.004). Moderate and severe side effects were not reported.
Conclusions This is the first study to indicate appropriate influenza A/H1N1 vaccine safety and efficacy in BD, reinforcing its recommendation. Disease activity impaired humoral response to vaccination. Further studies are necessary to determine if a second dose would increase seroconversion rates in these patients.
Fiore AE, Uyeki TM, Broder K, Finelli L, Euler GL, Singleton JA, Iskander JK, Wortley PM, Shay DK, Bresee JS, Cox NJ; Centers for Disease Control and Prevention (CDC). Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010.
Disclosure of Interest None Declared
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