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Antibody response after a single dose of an AS03-adjuvanted split-virion influenza A (H1N1) vaccine in heart transplant recipients.
Transplantation. 2011 May 15; 91(9):1031-5.T

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+Show Affiliations

Department of General and Interventional Cardiology, University Heart Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. sv.meyer@uke.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article

Language

eng

PubMed ID

21358365

Citation

Meyer, Sven, et al. "Antibody Response After a Single Dose of an AS03-adjuvanted Split-virion Influenza a (H1N1) Vaccine in Heart Transplant Recipients." Transplantation, vol. 91, no. 9, 2011, pp. 1031-5.
Meyer S, Adam M, Schweiger B, et al. Antibody response after a single dose of an AS03-adjuvanted split-virion influenza A (H1N1) vaccine in heart transplant recipients. Transplantation. 2011;91(9):1031-5.
Meyer, S., Adam, M., Schweiger, B., Ilchmann, C., Eulenburg, C., Sattinger, E., Runte, H., Schlüter, M., Deuse, T., Reichenspurner, H., & Costard-Jäckle, A. (2011). Antibody response after a single dose of an AS03-adjuvanted split-virion influenza A (H1N1) vaccine in heart transplant recipients. Transplantation, 91(9), 1031-5. https://doi.org/10.1097/TP.0b013e3182115be0
Meyer S, et al. Antibody Response After a Single Dose of an AS03-adjuvanted Split-virion Influenza a (H1N1) Vaccine in Heart Transplant Recipients. Transplantation. 2011 May 15;91(9):1031-5. PubMed PMID: 21358365.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Antibody response after a single dose of an AS03-adjuvanted split-virion influenza A (H1N1) vaccine in heart transplant recipients. AU - Meyer,Sven, AU - Adam,Matti, AU - Schweiger,Brunhilde, AU - Ilchmann,Corina, AU - Eulenburg,Christine, AU - Sattinger,Edgar, AU - Runte,Hendrik, AU - Schlüter,Michael, AU - Deuse,Tobias, AU - Reichenspurner,Hermann, AU - Costard-Jäckle,Angelika, PY - 2011/3/2/entrez PY - 2011/3/2/pubmed PY - 2011/7/2/medline SP - 1031 EP - 5 JF - Transplantation JO - Transplantation VL - 91 IS - 9 N2 - 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. SN - 1534-6080 UR - https://www.unboundmedicine.com/medline/citation/21358365/Antibody_response_after_a_single_dose_of_an_AS03_adjuvanted_split_virion_influenza_A__H1N1__vaccine_in_heart_transplant_recipients_ L2 - https://doi.org/10.1097/TP.0b013e3182115be0 DB - PRIME DP - Unbound Medicine ER -