title: Antibody response after a single dose of an AS03-adjuvanted split-virion influenza A (H1N1) vaccine in heart transplant recipients.
abstract: BACKGROUND
  Influenza A (H1N1) has emerged as a considerable threat for recipients of organ transplants. Vaccination against the novel influenza A (H1N1) virus has generally been advocated. There is limited experience with AS03-adjuvanted A/H1N1 pandemic influenza vaccines in immunosuppressed patients.
  
  
  METHODS
  We conducted an observational, nonrandomized single-center study to assess antibody response and vaccine-related adverse effects in 47 heart transplant recipients (44 men; age, 56±13 years). The AS03-adjuvanted, inactivated split-virion A/California/7/2009 H1N1v pandemic vaccine was administered. Antibody titers were measured using hemagglutination inhibition; immunoglobulin G (IgG) response was assessed using a new pandemic influenza A IgG enzyme-linked immunosorbent assay (ELISA) test kit and compared with hemagglutination-inhibition titers. Adverse effects of vaccination were assessed by a questionnaire.
  
  
  RESULTS
  Postvaccination antibody titers of greater than or equal to 1:40 were found in only 15 patients, corresponding to a seroprotection rate of 32% (95% confidence interval, 19%-47%). Sensitivity, specificity, positive predictive value, and negative predictive value of ELISA testing were 80.0%, 68.8%, 54.5%, and 88.0%, respectively. Age, time posttransplantation, and immunosuppressive regimen did not impact antibody response. Vaccination was well tolerated.
  
  
  CONCLUSIONS
  Single-dose administration of an AS03-adjuvanted vaccine against the novel influenza A (H1N1) virus did not elicit seroprotective antibody concentrations in a substantial proportion of heart transplant recipients; the new pandemic influenza A IgG ELISA test kit proved to be of limited clinical use.
authors.affiliation: Department of General and Interventional Cardiology, University Heart Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. sv.meyer@uke.de
authors.forename: Sven
authors.initials: S
authors.lastname: Meyer
authors.forename: Matti
authors.initials: M
authors.lastname: Adam
authors.forename: Brunhilde
authors.initials: B
authors.lastname: Schweiger
authors.forename: Corina
authors.initials: C
authors.lastname: Ilchmann
authors.forename: Christine
authors.initials: C
authors.lastname: Eulenburg
authors.forename: Edgar
authors.initials: E
authors.lastname: Sattinger
authors.forename: Hendrik
authors.initials: H
authors.lastname: Runte
authors.forename: Michael
authors.initials: M
authors.lastname: Schlüter
authors.forename: Tobias
authors.initials: T
authors.lastname: Deuse
authors.forename: Hermann
authors.initials: H
authors.lastname: Reichenspurner
authors.forename: Angelika
authors.initials: A
authors.lastname: Costard-Jäckle
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood*; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D016027:Heart Transplantation / Q000276:immunology*; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D007251:Influenza, Human / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D058873:Pandemics / Q000517:prevention & control
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007074:Immunoglobulin G; D007252:Influenza Vaccines