title: Vaccination of patients with mild and severe asthma with a 2009 pandemic H1N1 influenza virus vaccine.
abstract: BACKGROUND
  Asthma was the most common comorbidity of patients hospitalized with 2009 H1N1 influenza.
  
  
  OBJECTIVE
  We sought to assess the immunogenicity and safety of an unadjuvanted, inactivated 2009 H1N1 vaccine in patients with severe versus mild-to-moderate asthma.
  
  
  METHODS
  We conducted an open-label study involving 390 participants (age, 12-79 years) enrolled in October-November 2009. Severe asthma was defined as need for 880 μg/d or more of inhaled fluticasone equivalent, systemic corticosteroids, or both. Within each severity group, participants were randomized to receive intramuscularly 15 or 30 μg of 2009 H1N1 vaccine twice 21 days apart. Immunogenicity end points were seroprotection (hemagglutination inhibition assay titer ≥40) and seroconversion (4-fold or greater titer increase). Safety was assessed through local and systemic reactogenicity, asthma exacerbations, and pulmonary function.
  
  
  RESULTS
  In patients with mild-to-moderate asthma (n = 217), the 2009 H1N1 vaccine provided equal seroprotection 21 days after the first immunization at the 15-μg (90.6%; 95% CI, 83.5% to 95.4%) and 30-μg (95.3%; 95% CI, 89.4% to 98.5%) doses. In patients with severe asthma (n = 173), seroprotection 21 days after the first immunization was 77.9% (95% CI, 67.7% to 86.1%) and 94.1% (95% CI, 86.8% to 98.1%) at the 15- and 30-μg doses, respectively (P = .004). The second vaccination did not provide further increases in seroprotection. Participants with severe asthma who are older than 60 years showed the lowest seroprotection (44.4% at day 21) with the 15-μg dose but had adequate seroprotection with 30 μg. The 2 dose groups did not differ in seroconversion rates. There were no safety concerns.
  
  
  CONCLUSIONS
  Monovalent inactivated 2009 H1N1 pandemic influenza vaccine was safe and provided overall seroprotection as a surrogate of efficacy. In patients older than 60 years with severe asthma, a 30-μg dose might be more appropriate.
authors.affiliation: University of Wisconsin School of Medicine and Public Health, Madison, Wis., USA. wwb@medicine.wisc.edu
authors.forename: William W
authors.initials: WW
authors.lastname: Busse
authors.forename: Stephen P
authors.initials: SP
authors.lastname: Peters
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Fenton
authors.forename: Herman
authors.initials: H
authors.lastname: Mitchell
authors.forename: Eugene R
authors.initials: ER
authors.lastname: Bleecker
authors.forename: Mario
authors.initials: M
authors.lastname: Castro
authors.forename: Sally
authors.initials: S
authors.lastname: Wenzel
authors.forename: Serpil C
authors.initials: SC
authors.lastname: Erzurum
authors.forename: Anne M
authors.initials: AM
authors.lastname: Fitzpatrick
authors.forename: W Gerald
authors.initials: WG
authors.lastname: Teague
authors.forename: Nizar
authors.initials: N
authors.lastname: Jarjour
authors.forename: Wendy C
authors.initials: WC
authors.lastname: Moore
authors.forename: Kaharu
authors.initials: K
authors.lastname: Sumino
authors.forename: Scott
authors.initials: S
authors.lastname: Simeone
authors.forename: Suphagaphan
authors.initials: S
authors.lastname: Ratanamaneechat
authors.forename: Madhuri
authors.initials: M
authors.lastname: Penugonda
authors.forename: Benjamin
authors.initials: B
authors.lastname: Gaston
authors.forename: Ted M
authors.initials: TM
authors.lastname: Ross
authors.forename: Steve
authors.initials: S
authors.lastname: Sigelman
authors.forename: Joella R
authors.initials: JR
authors.lastname: Schiepan
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Zaccaro
authors.forename: Corey J
authors.initials: CJ
authors.lastname: Crevar
authors.forename: Donald M
authors.initials: DM
authors.lastname: Carter
authors.forename: Alkis
authors.initials: A
authors.lastname: Togias
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001249:Asthma / Q000453:epidemiology / Q000276:immunology*; D002648:Child; D015897:Comorbidity; D005260:Female; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D014611:Vaccination; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines