Focetria (Novartis) monovalent inactivated pandemic influenza vaccine corresponding to 7.5 mg of haemagglutinin (HA) antigen strain A/California/7/2009 (H1N1)v like strain (X-179A) MF59-adjuvanted between November 2009 and February 2010.The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm on day 0. Blood samples were collected on day 0 and on day 21 to assess immunogenicity according to the Committee for Proprietary Medicinal Products (CPMP) criteria 5 ; CD4 T cell counts were also assessed on day 0 to exclude immunodeficiency.Patients or their parents recorded in a diary card the onset and severity of solicited local and systemic reactions within 7 days after the vaccine administration.We enrolled 48 CF patients with an average good pulmonary function and nutritional status.They showed normal CD4 T cell counts.All patients were assessed for safety and 33 of them for immunogenicity.There were no dropouts because of adverse reactions.The vaccine was well tolerated and no serious adverse events have been reported.All recorded symptoms were mild and shortlasting.The most frequent reported symptoms were local reactions.Seroconversion rate was satisfactory and met all the CPMP criteria.Demographics, immunogenicity and safety data are shown in table 1.In conclusion, a single 7.5 mg dose of the monovalent A/H1N1 MF59-adjuvanted vaccine results in a high rate of seroconver-sion in CF patients.These data support the current influenza vaccination strategy.The vaccine is well tolerated and the frequency of adverse events is comparable with literature data regarding other influenza vaccines.However, we studied a small cohort of young patients with an overall good nutritional and lung status.In severe malnourished CF patients, supposed to have a decreased immune response, the vaccine may not have the same efficacy.Future prospectical studies are needed to evaluate the benefits of influenza vaccines on defined clinical outcomes.
Background Few studies, based on a limited number of patients using non-uniform therapeutic protocols, have analyzed Methicillin-resistant Staphylococcus aureus (MRSA) eradication. Methods In a randomized multicenter trial conducted on patients with new-onset MRSA infection we evaluated the efficacy of an early eradication treatment (arm A) compared with an observational group (B). Arm A received oral rifampicin and trimethoprim/sulfamethoxazole (21 days). Patients' microbiological status, FEV1, BMI, pulmonary exacerbations and use of antibiotics were assessed. Results Sixty-one patients were randomized. Twenty-nine (47.5%) patients were assigned to active arm A and 32 (52.5%) patients to observational arm B. Twenty-nine (47.5%) patients, 10 patients in arm A and 19 in arm B, dropped out of the study. At 6 months MRSA was eradicated in 12 (63.2%) out of 19 patients in arm A while spontaneous clearance was observed in 5 (38.5%) out of 13 patients in arm B. A per-protocol analysis showed a 24.7% difference in the proportion of MRSA clearance between the two groups (z = 1.37, P(Z>z) = 0.08). Twenty-seven patients, 15 (78.9%) out of 19 in arm A and 12 (92.3%) out of 13 in arm B, were able to perform spirometry. The mean (±SD) FEV1 change from baseline was 7.13% (±14.92) in arm A and -1.16% (±5.25) in arm B (p = 0.08). In the same period the BMI change (mean ±SD) from baseline was 0.54 (±1.33) kg/m2 in arm A and -0.38 (±1.56) kg/m2 in arm B (p = 0.08). At 6 months no statistically significant differences regarding the number of pulmonary exacerbations, days spent in hospital and use of antibiotics were observed between the two arms. Conclusions Although the statistical power of the study is limited, we found a 24.7% higher clearance of MRSA in the active arm than in the observational arm at 6 months. Patients in the active arm A also had favorable FEV1 and BMI tendencies.
