BACKGROUND Asthma was the most common comorbidity of patients hospitalized with 2009 H1N1 influenza. OBJECTIVE To assess immunogenicity and safety of an unadjuvanted, inactivated 2009 H1N1 vaccine in severe versus mild/moderate asthma. METHODS We conducted an open-label study involving 390 participants (age:12–79y) enrolled in October-November 2009. Severe asthma was defined as need for ≥880mcg/d of inhaled fluticasone equivalent and/or systemic corticosteroids. Within each severity group, participants were randomized to receive intramuscularly 15mcg or 30mcg of 2009 H1N1 vaccine twice, 21 days apart. Immunogenicity endpoints were seroprotection (≥40 titer in hemagglutination inhibition assay) and seroconversion (4-fold or greater titer increase). Safety was assessed through local and systemic reactogenicity, asthma exacerbations and pulmonary function. RESULTS In mild/moderate asthma (N=217), the 2009 H1N1 vaccine provided equal seroprotection 21 days after the first immunization at the 15mcg (90.6%,CI:83.5–95.4) and 30mcg (95.3%,CI:89.4–98.5) doses. In severe asthma (N=173), seroprotection 21 days after the first immunization was 77.9% (CI:67.7–86.1) and 94.1% (CI:86.8–98.1) at the 15mcg and 30mcg dose, respectively (p=0.004). The second vaccination did not provide further increases in seroprotection. Participants with severe asthma ≥60y showed the lowest seroprotection (44.4% at Day 21) with the 15mcg dose, but had adequate seroprotection with 30mcg. The two dose groups did not differ in seroconversion rates. There were no safety concerns. CONCLUSION Monovalent inactivated 2009 H1N1 pandemic influenza vaccine was safe and provided overall seroprotection as a surrogate of efficacy. In severe asthma participants over 60y, a 30mcg dose may be more appropriate.

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