Original InvestigationDialysisImmunogenicity and Efficacy in Hemodialysis Patients of an AS03A-Adjuvanted Vaccine for 2009 Pandemic Influenza A(H1N1): A Nonrandomized Trial
Section snippets
Study Design
The primary objective of this nonrandomized trial was to assess the efficacy and safety of AS03A-adjuvanted 2009 pandemic influenza A(H1N1) vaccination with 1 and 2 doses as analyzed using the Pandemic New Influenza A immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA; Genzyme Virotech, www.virotech.de) in long-term hemodialysis patients. Additional assessments included evaluation of the antipandemic H1N1 antibody titer in patients without vaccination and evaluation of an
Study Population
Altogether, 292 patients with end-stage renal disease receiving regular hemodialysis therapy (mean, 4.6 ± 0.4 hours) participated in this nonrandomized trial (171 men, 121 women; mean age, 68.8 ± 13.8 years; range, 28-92 years; Fig 1). Patient demographics for 169 patients with AS03A-adjuvanted pandemic H1N1 vaccination and 123 control patients without vaccination are listed in Table 1.
Unvaccinated Hemodialysis Patients
Long-term hemodialysis patients without pandemic H1N1 vaccination (control cohort) showed a wide range of IgG
Discussion
In this nonrandomized trial, we showed that AS03A-adjuvanted vaccination against 2009 pandemic influenza A(H1N1) is immunogenic and efficient in hemodialysis patients despite uremia-related immune dysfunction, with an acceptable safety profile. After a single dose of pandemic H1N1 vaccine, 41 of 64 (64.1%) hemodialysis patients showed a positive response compared with 98.2% of 130 healthy adults.15 These data suggest that a single dose is sufficient for immunizing healthy adults, which agrees
Acknowledgements
Support: The authors thank Genzyme Virotech for providing the Pandemic New Influenza IgG ELISA.
Financial Disclosure: The authors declare that they have no relevant financial interests.
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Originally published online February 24, 2011.