title: Pandemic whole-virion, Vero-cell-derived, adjuvant-free influenza A H1N1 vaccine in patients with solid tumors and hematologic malignancies receiving concurrent anticancer treatment: Immunogenicity, tolerability, and acceptability during the pandemic situation.
abstract: Patients with malignancies are considered to be at increased risk of acquiring influenza. Because of higher complication and case fatality rates, preventive measures such as vaccination are of great interest. The objective of this study was to assess the acceptability, tolerability and immunogenicity of an adjuvant-free whole-virion pandemic influenza A (H1N1) vaccine in cancer patients with ongoing anticancer treatment during a 'pandemic situation'. Adult patients with hematologic malignancies or solid tumors and concurrent cytotoxic, targeted, and/or hormone therapy were recruited during the influenza A (H1N1) pandemic in 2009/2010 and were offered free vaccine. Antibody titers were measured using virus-specific hemagglutination inhibition assay and ELISA. Among 285 patients with solid tumors who were offered vaccination during their therapy, 260 (91.2%) declined and 25 (8.8%) accepted. Seventeen patients with hematologic malignancies were also vaccinated during therapy; 23 healthy individuals served as a control group. When measured using hemagglutination-inhibition assays, rates of seroprotection, seroconversion, and geometric mean titer ratios after the second vaccination were 96%, 70%, and 4.1 respectively among the healthy individuals, 90%, 52%, and 4.3 among patients with solid tumors, and 67%, 13%, and 1.5 among patients with hematologic malignancies during therapy (P<0.05). When measured using ELISA, seropositivity differed significantly among the three groups after the second vaccination: healthy individuals 74%, patients with solid tumors 57%, those with hematologic malignancies 13% (P<0.001). The vaccine was well tolerated. Our results demonstrate a low uptake of the well tolerated adjuvant-free influenza A (H1N1) vaccine by cancer patients receiving anticancer treatment during the pandemic of 2009/2010. Among the vaccinated patients, the immune response was weaker than that in healthy individuals. The immune response in patients with hematological malignancies was low. Two doses of vaccine are needed in these immunosuppressed patients.
authors.affiliation: Department of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Austria. heimo.lagler@meduniwien.ac.at
authors.forename: Heimo
authors.initials: H
authors.lastname: Lagler
authors.forename: Selma
authors.initials: S
authors.lastname: Tobudic
authors.forename: Michael
authors.initials: M
authors.lastname: Ramharter
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Elandt
authors.forename: Wolfgang R
authors.initials: WR
authors.lastname: Sperr
authors.forename: Monika
authors.initials: M
authors.lastname: Redlberger-Fritz
authors.forename: Theresia
authors.initials: T
authors.lastname: Popow-Kraupp
authors.forename: Ulrich
authors.initials: U
authors.lastname: Jäger
authors.forename: Christoph C
authors.initials: CC
authors.lastname: Zielinski
authors.forename: Heinz
authors.initials: H
authors.lastname: Burgmann
mesh_terms: D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood; D000970:Antineoplastic Agents / Q000008:administration & dosage; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy / Q000276:immunology; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data
chemical_list: D000914:Antibodies, Viral; D000970:Antineoplastic Agents; D007252:Influenza Vaccines