title: Immunogenicity of an adjuvanted 2009 pandemic influenza A (H1N1) vaccine in haemodialysed patients.
abstract: BACKGROUND
  The 2009 pandemic of influenza A (H1N1) prompted an urgent worldwide vaccination campaign, especially of high-risk subjects, such as maintenance haemodialysis (HD) patients. Still the immunogenicity of the pandemic A (H1N1) vaccine in HD patients is unknown.
  
  
  METHODS
  We prospectively studied the immunogenicity of a monovalent adjuvanted influenza A/California/2009 (H1N1) vaccine (Pandemrix, GSK Biologicals, Rixensart, Belgium) in HD patients and controls. Antibody level was measured using a seroneutralization assay before (D(0)) and 30 days after (D(30)) a single 3.75 μg vaccine dose. Specimens were tested in quadruplicates. Geometric mean (GM) antibody titers were determined in each subject at D(0) and D(30). Seroconversion was defined as an increase in GM titers by a factor 4 or more.
  
  
  RESULTS
  Fifty-three adult HD patients [aged 71 ± 10, 58.5% males, on HD for a median of 38 (3 - 146) months] and 32 control subjects (aged 47.3 ± 14, 31.3% males) were analyzed. Baseline GM titers were similar in HD patients and controls [7.9 (6.6 - 9.6) vs 10 (6 - 17); p = 0.69]. Seroconversion was observed in 30 (93.8%) controls and 34 (64.2%) HD patients (p = 0.002). In addition, GM titers at D(30) were significantly higher in controls than in HD patients [373 (217 - 640) vs 75.5 (42.5 - 134); p = 0.001]. HD patients were significantly older than controls (p < 0.001) and more likely to be males (p = 0.02). However, by multivariate analysis, HD status [OR 0.13 (0.02-0.78), p = 0.03], but neither age [OR 0.99 (0.96 - 1.03); p = 0.7] nor male gender [OR 1.31 (0.45 - 3.85); p = 0.63] was independently associated with seroconversion. The vaccine was generally well tolerated by HD patients.
  
  
  CONCLUSIONS
  Only 64% of chronic HD patients developed seroconversion after a single dose of adjuvanted influenza A (H1N1) vaccine, a much lower rate than in controls (94%). These results underscore the substantial immunodeficiency associated with End-Stage Renal Disease. The persistence of protective antibodies as well as the effect of a booster dose remain to be investigated in HD patients.
authors.affiliation: Department of Nephrology, Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium. laura.labriola@nefr.ucl.ac.be
authors.forename: Laura
authors.initials: L
authors.lastname: Labriola
authors.forename: Anneleen
authors.initials: A
authors.lastname: Hombrouck
authors.forename: Céline
authors.initials: C
authors.lastname: Maréchal
authors.forename: Steven
authors.initials: S
authors.lastname: Van Gucht
authors.forename: Bernard
authors.initials: B
authors.lastname: Brochier
authors.forename: Isabelle
authors.initials: I
authors.lastname: Thomas
authors.forename: Michel
authors.initials: M
authors.lastname: Jadoul
authors.forename: Patrick
authors.initials: P
authors.lastname: Goubau
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016022:Case-Control Studies; D005260:Female; D005500:Follow-Up Studies; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D007676:Kidney Failure, Chronic / Q000628:therapy; D008297:Male; D008875:Middle Aged; D058873:Pandemics; D011379:Prognosis; D011446:Prospective Studies; D006435:Renal Dialysis; D015996:Survival Rate; D014611:Vaccination; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines