title: Evaluation of 2009 pandemic H1N1 influenza vaccination in adults with lymphoid malignancies receiving chemotherapy or following autologous stem cell transplant.
abstract: This is a randomized trial evaluating the safety and immunogenicity of one or two doses of 2009 pandemic H1N1 influenza vaccination in adults with lymphoid malignancies. Adults with a lymphoid malignancy receiving active systemic therapy, or within a year after autologous stem cell transplant, received one dose of AS03-adjuvanted A/California/7/2009 (H1N1) vaccine, and were randomized 21 days later to a second dose or no further vaccination. The primary outcomes were seroprotection and seroconversion rates by hemagglutination inhibition 21 and 42 days after initial vaccination. Twenty-two patients received one dose, and 20 patients received a second dose. Seroconversion rates at day 21 were 30% (one dose) and 5% (two doses), and subsequently 30% for both groups at day 42. Seroprotection rates at day 21 were 40% (one dose) and 15% (two doses), and subsequently 35% (one dose) and 40% (two doses) at day 42. Differences in serologic endpoints were not statistically significant between both study arms at day 42. Patients with low levels of B-cells (CD19-positive) had low seroconversion rates on days 21 (odds ratio [OR] 0.74, 95% confidence interval [CI] 0.59-0.93, p = 0.043) and 42 (OR 0.12, 95% CI 0.01-1.07, p = 0.058). Only three of the 14 patients who received rituximab achieved seroprotective titers by day 42. Patients with lymphoid malignancies did not achieve rates of seroconversion or seroprotection seen in healthy subjects despite a second dose and the use of an adjuvant. Notwithstanding suboptimal immunogenicity, seasonal and pandemic influenza vaccination should continue to be recommended.
authors.affiliation: Division of Medical Oncology and Hematology, Princess Margaret Hospital, Toronto, Ontario, Canada.
authors.forename: Diego
authors.initials: D
authors.lastname: Villa
authors.forename: Jonathan
authors.initials: J
authors.lastname: Gubbay
authors.forename: D Robert
authors.initials: DR
authors.lastname: Sutherland
authors.forename: Robert
authors.initials: R
authors.lastname: Laister
authors.forename: Allison
authors.initials: A
authors.lastname: McGeer
authors.forename: Curtis
authors.initials: C
authors.lastname: Cooper
authors.forename: Edgardo S
authors.initials: ES
authors.lastname: Fortuno
authors.forename: Wei
authors.initials: W
authors.lastname: Xu
authors.forename: Lily
authors.initials: L
authors.lastname: Shi
authors.forename: Vishal
authors.initials: V
authors.lastname: Kukreti
authors.forename: Michael
authors.initials: M
authors.lastname: Crump
authors.forename: John
authors.initials: J
authors.lastname: Kuruvilla
mesh_terms: D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood / Q000276:immunology; D000971:Antineoplastic Combined Chemotherapy Protocols; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007155:Immunologic Factors / Q000097:blood / Q000276:immunology; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000150:complications* / Q000276:immunology / Q000517:prevention & control*; D007945:Leukemia, Lymphoid / Q000150:complications* / Q000276:immunology / Q000628:therapy; D008223:Lymphoma / Q000150:complications* / Q000276:immunology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D014182:Transplantation, Autologous; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D007155:Immunologic Factors; D007252:Influenza Vaccines