title: Immunogenicity and reactogenicity of 2009 influenza A (H1N1) inactivated monovalent non-adjuvanted vaccine in elderly and immunocompromised patients.
abstract: BACKGROUND
  Immunosuppressed individuals present serious morbidity and mortality from influenza, therefore it is important to understand the safety and immunogenicity of influenza vaccination among them.
  
  
  METHODS
  This multicenter cohort study evaluated the immunogenicity and reactogenicity of an inactivated, monovalent, non-adjuvanted pandemic (H1N1) 2009 vaccine among the elderly, HIV-infected, rheumatoid arthritis (RA), cancer, kidney transplant, and juvenile idiopathic arthritis (JIA) patients. Participants were included during routine clinical visits, and vaccinated according to conventional influenza vaccination schedules. Antibody response was measured by the hemagglutination-inhibition assay, before and 21 days after vaccination.
  
  
  RESULTS
  319 patients with cancer, 260 with RA, 256 HIV-infected, 149 elderly individuals, 85 kidney transplant recipients, and 83 with JIA were included. The proportions of seroprotection, seroconversion, and the geometric mean titer ratios postvaccination were, respectively: 37.6%, 31.8%, and 3.2 among kidney transplant recipients, 61.5%, 53.1%, and 7.5 among RA patients, 63.1%, 55.7%, and 5.7 among the elderly, 59.0%, 54.7%, and 5.9 among HIV-infected patients, 52.4%, 49.2%, and 5.3 among cancer patients, 85.5%, 78.3%, and 16.5 among JIA patients. The vaccine was well tolerated, with no reported severe adverse events.
  
  
  CONCLUSIONS
  The vaccine was safe among all groups, with an acceptable immunogenicity among the elderly and JIA patients, however new vaccination strategies should be explored to improve the immune response of immunocompromised adult patients. (ClinicalTrials.gov, NCT01218685).
authors.affiliation: Butantan Institute-Clinical Trials Division, São Paulo, Brazil. joaomiraglia@gmail.com
authors.forename: João L
authors.initials: JL
authors.lastname: Miraglia
authors.forename: Edson
authors.initials: E
authors.lastname: Abdala
authors.forename: Paulo M
authors.initials: PM
authors.lastname: Hoff
authors.forename: André M
authors.initials: AM
authors.lastname: Luiz
authors.forename: Danise S
authors.initials: DS
authors.lastname: Oliveira
authors.forename: Carla G S
authors.initials: CG
authors.lastname: Saad
authors.forename: Ieda M M
authors.initials: IM
authors.lastname: Laurindo
authors.forename: Ana T R
authors.initials: AT
authors.lastname: Viso
authors.forename: Angela
authors.initials: A
authors.lastname: Tayra
authors.forename: Lígia C
authors.initials: LC
authors.lastname: Pierrotti
authors.forename: Luiz S
authors.initials: LS
authors.lastname: Azevedo
authors.forename: Lúcia Maria A
authors.initials: LM
authors.lastname: Campos
authors.forename: Nádia E
authors.initials: NE
authors.lastname: Aikawa
authors.forename: Maria do Carmo S T
authors.initials: Mdo C
authors.lastname: Timenetsky
authors.forename: Expedito
authors.initials: E
authors.lastname: Luna
authors.forename: Maria Regina A
authors.initials: MR
authors.lastname: Cardoso
authors.forename: José da S
authors.initials: Jda S
authors.lastname: Guedes
authors.forename: Isaias
authors.initials: I
authors.lastname: Raw
authors.forename: Jorge
authors.initials: J
authors.lastname: Kalil
authors.forename: Alexander R
authors.initials: AR
authors.lastname: Precioso
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001171:Arthritis, Juvenile; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D015897:Comorbidity; D005260:Female; D015658:HIV Infections; D006801:Humans; D056724:Immunity, Humoral; D016867:Immunocompromised Host / Q000187:drug effects / Q000276:immunology*; D055261:Immunogenetic Phenomena; D053118:Influenza A Virus, H1N1 Subtype; D007252:Influenza Vaccines / Q000276:immunology / Q000494:pharmacology* / Q000627:therapeutic use; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009369:Neoplasms; D015164:Vaccines, Inactivated / Q000494:pharmacology / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
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