tetano
Editor, Senior Moderator
Transplantation. 2011 Feb 23. [Epub ahead of print]
Antibody Response After a Single Dose of an AS03-Adjuvanted Split-Virion Influenza A (H1N1) Vaccine in Heart Transplant Recipients.
Meyer S, Adam M, Schweiger B, Ilchmann C, Eulenburg C, Sattinger E, Runte H, Schl?ter M, Deuse T, Reichenspurner H, Costard-J?ckle A.
1 Department of General and Interventional Cardiology, University Heart Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 2 Robert Koch Institute, Berlin, Germany. 3 Department of Medical Microbiology, Virology and Hygiene, University Heart Center; University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 4 Department of Medical Biometry and Epidemiology, University Heart Center; University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 5 Department of Cardiovascular Surgery, University Heart Center; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
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.
PMID: 21358365 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/21358365
Antibody Response After a Single Dose of an AS03-Adjuvanted Split-Virion Influenza A (H1N1) Vaccine in Heart Transplant Recipients.
Meyer S, Adam M, Schweiger B, Ilchmann C, Eulenburg C, Sattinger E, Runte H, Schl?ter M, Deuse T, Reichenspurner H, Costard-J?ckle A.
1 Department of General and Interventional Cardiology, University Heart Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 2 Robert Koch Institute, Berlin, Germany. 3 Department of Medical Microbiology, Virology and Hygiene, University Heart Center; University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 4 Department of Medical Biometry and Epidemiology, University Heart Center; University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 5 Department of Cardiovascular Surgery, University Heart Center; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
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.
PMID: 21358365 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/21358365