Influenza A/H1N1 Vaccine in Patients Treated by Kidney Transplant or Dialysis

Abstract

SummaryBackground and objectives In 2009, the pandemic influenza A/H1N1 accounted for worldwide recommendations about vaccination. There are few data concerning the immunogenicity or the security of the adjuvanted-A/H1N1 vaccine in transplanted and hemodialyzed patients.Design, setting, participants, & measurements Sera from 21 controls, 53 hemodialyzed (HD) patients, and 111 renal transplant recipients (RT) were sampled before (T0) and 1 month after (T1) a single dose of Pandemrix® vaccine (GSK Biologicals, AS03-adjuvanted). We measured the neutralizing antibodies against A/H1N1/2009, the geometric mean (GM) titers, the GM titer ratios (T1/T0) with 95% confidence intervals, and the seroconversion rate (responders: Ն4-fold increase in titer). The HLA and MICA immunization was determined by Luminex technology. ResultsThe GM titer ratio was 38 (19 to 78), 9 (5 to 16), and 5 (3 to 6) for controls, HD patients, and RT patients, respectively (P Ͻ 0.001). The proportion of responders was 90%, 57%, and 44%, respectively (P Ͻ 0.001). In RT patients, the prevalence of histocompatibility leukocyte antigen (HLA) class I, histocompatibility leukocyte antigen class II, and MHC class I-related chain A immunization, was, respectively, 15%, 14%, and 14% before and 14%, 14%, and 11% after vaccination (P ϭ 1, 1, and 0.39). ConclusionsThe influenza A/H1N1-adjuvanted vaccine is of limited efficacy but is safe in renal disease populations. The humoral response is lower in transplanted versus hemodialyzed patients. Further studies are needed to improve the efficacy of vaccination in those populations.

Serological response to influenza A H1N1 vaccine (Pandemrix®) and seasonal influenza vaccine 2009/2010 in renal transplant recipients and in hemodialysis patients

“…Comparable to the present analysis, most of these studies used the hemagglutination inhibition (HI) assay to measure relevant HI titers. Two reports are based on data obtained by enzyme immunoassay technique [27,29], and in one report, neutralizing antibodies against pandemic H1N1 were determined [28]. To our knowledge, the present investigation is the only study on hemodialysis patients and renal transplant recipients, which investigates serological response to pandemic H1N1 vaccination and seasonal inXuenza vaccination in parallel.…”

“…Several studies have analyzed the serological response to vaccination against pandemic H1N1 in renal transplant recipients and hemodialysis patients [9,[26][27][28][29][30]. Comparable to the present analysis, most of these studies used the hemagglutination inhibition (HI) assay to measure relevant HI titers.…”

“…One explanation could be the method itself: Several authors have shown that the hemagglutination inhibition test is less sensitive compared to tests that detect virus-neutralizing antibodies [36,37]. However, Broeders et al [28] have tested post-vaccination sera of renal transplant recipients and hemodialysis patients for the presence of neutralizing antibodies against the pandemic H1N1 strain and found similar to this study that in these patients, the vaccine is of limited eYcacy [28]. Thus, larger prospective studies on the eYcacy of adjuvanted and non-adjuvanted inXuenza vaccines in immunosuppressed patients are urgently needed which should include virological survey of vaccinees in order to demonstrate protection through vaccination.…”

Prophylactic vaccinations in chronic kidney disease: Current status

“…73 AS03 has been safely administered with the A(H1N1) pdm09 and the H5N1 strains to thousands of healthy adults. 74 The rate of seroconversion to AS03 adjuvanted A(H1N1) pdm09 vaccine was 57% -64.2% in HD patients 75,76 and 35% -44% in renal transplant patients 75,77 , whereas it was 90% -93.8% in a control population. 75,76 Vaccine dose was an independent factor for response to pandemic A(H1N1) vaccination in HD subjects.…”

“…74 The rate of seroconversion to AS03 adjuvanted A(H1N1) pdm09 vaccine was 57% -64.2% in HD patients 75,76 and 35% -44% in renal transplant patients 75,77 , whereas it was 90% -93.8% in a control population. 75,76 Vaccine dose was an independent factor for response to pandemic A(H1N1) vaccination in HD subjects. 78 Annual influenza vaccination is also recommended for HD or kidney transplanted adolescents or young adults.…”