title: A pilot randomized trial of adjuvanted influenza vaccine in adult allogeneic hematopoietic stem cell transplant recipients.
abstract: The annual influenza vaccine is recommended for hematopoietic stem cell transplant (HSCT) patients although studies have shown suboptimal immunogenicity. Influenza vaccine containing an oil-in-water emulsion adjuvant (MF59) may lead to greater immunogenicity in HSCT recipients. We randomized adult allogeneic HSCT patients to receive the 2015-2016 influenza vaccine with or without MF59 adjuvant. Preimmunization and 4-week post-immunization sera underwent strain-specific hemagglutination inhibition assay. We randomized 73 patients and 67 (35 adjuvanted; 32 non-adjuvanted) had paired samples available at follow-up. Median age was 54 years (range 22-74) and time from transplant was 380 days (range 85-8107). Concurrent graft-versus-host disease was seen in 42/73 (57.5%). Geometric mean titers increased significantly after vaccination in both groups. Seroconversion to at least one of three influenza antigens was present in 62.9% vs 53.1% in adjuvanted vs non-adjuvanted vaccine (P=0.42). Factors associated with lower seroconversion rates were use of calcineurin inhibitors (P<0.001) and shorter duration from transplantation (P=0.001). Seroconversion rates were greater in patients who got previous year influenza vaccination (82.6% vs 45.5%, P=0.03). Adjuvanted vaccine demonstrated similar immunogenicity to non-adjuvanted vaccine in the HSCT population and may be an option for some patients.
authors.affiliation: Division of Infectious Diseases, University Health Network, University of Toronto, Toronto, ON, Canada.
authors.forename: Y
authors.initials: Y
authors.lastname: Natori
authors.affiliation: Division of Infectious Diseases, University Health Network, University of Toronto, Toronto, ON, Canada.
authors.forename: A
authors.initials: A
authors.lastname: Humar
authors.affiliation: Allogeneic Blood and Marrow Transplant Program, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
authors.forename: J
authors.initials: J
authors.lastname: Lipton
authors.affiliation: Allogeneic Blood and Marrow Transplant Program, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
authors.forename: D D
authors.initials: DD
authors.lastname: Kim
authors.affiliation: Division of Infectious Diseases, University Health Network, University of Toronto, Toronto, ON, Canada.
authors.forename: P
authors.initials: P
authors.lastname: Ashton
authors.affiliation: Public Health England, London, UK.
authors.forename: K
authors.initials: K
authors.lastname: Hoschler
authors.affiliation: Division of Infectious Diseases, University Health Network, University of Toronto, Toronto, ON, Canada.
authors.forename: D
authors.initials: D
authors.lastname: Kumar
mesh_terms: D000328:Adult; D000368:Aged; D000956:Antigens, Viral / Q000008:administration & dosage* / Q000276:immunology; D005260:Female; D006086:Graft vs Host Disease; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000276:immunology; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011136:Polysorbates / Q000008:administration & dosage*; D013185:Squalene / Q000008:administration & dosage* / Q000276:immunology
chemical_list: D000956:Antigens, Viral; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D013185:Squalene