Journal
HAEMATOLOGICA-THE HEMATOLOGY JOURNAL
Volume 96, Issue 6, Pages 896-904Publisher
FERRATA STORTI FOUNDATION
DOI: 10.3324/haematol.2011.040386
Keywords
influenza A (H1N1); vaccination; allogeneic hematopoietic stem cell transplantation; GvHD; swine flu; antibodies
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Funding
- Centre for Clinical Research and Centre for Vaccinology (Geneva University Hospital and Faculty of Medicine of the University of Geneva)
- Louis Jeantet Foundation
- Federal Office of Public Health
- Swiss National Science Foundation [310030 127516]
- Dr Henri Dubois-Ferriere-Dinu Lipatti Foundation
- Swiss National Science Foundation (SNF) [310030_127516] Funding Source: Swiss National Science Foundation (SNF)
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Background Responses to influenza vaccines are poorly characterized in immunocompromised patients. The goal of this study was to assess the efficacy of the AS03-adjuvanted influenza H1N1/A/09 vaccine in allogeneic hematopoietic stem cell transplant recipients. Design and Methods We enrolled 65 patients and 138 controls in an open prospective study. Controls received one dose and patients 2 doses of the AS03-adjuvanted influenza H1N1/A/09 vaccine at a 3-week interval. Geometric mean titers and seroprotection/seroconversion rates were determined by hemagglutination inhibition before and four weeks after the last immunization. Clinical and biological markers, including immunoglobulins, CD3(+), CD4(+), CD8(+) and naive CD4(+) T-cell counts were assessed in all patients. Results Baseline seroprotection rates were low in patients (6.6%) and controls (14.8%). After 2 doses, patients (n=57, 92.3%) achieved similar seroprotection rates (84% vs. 87%, P=0.65) and antibody titers (305 vs. 340, P=0.88) as controls (n=131, 93.9%) after one dose. In univariate analysis, transplant-to-vaccination interval less than 12 months, active graft-versus-host disease, immunosuppressive drugs, hemoglobin less than 12g/L, lymphopenia less than1G/L, IgG less than 4g/L, IgA less than 0.5g/L, IgM less than 0.5g/L and naive CD4(+) T cells less than 150/mu L were significantly associated with weaker responses. Multivariate analysis identified transplant-to-vaccination interval and active graft-versus-host disease as the most powerful negative predictors of antibody responses (P=0.04 and P=0.002, respectively). Vaccination was well tolerated in both cohorts. Conclusions In allogeneic hematopoietic stem cell transplant recipients, 2 doses of an adjuvanted influenza vaccine elicited comparable responses to a single dose in healthy individuals. However, vaccine responses remained poor in patients with ongoing graft-versus-host disease, supporting the need for additional strategies in this high-risk patient population. (ClinicalTrials.gov Identifier: NCT01022905)
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