title: Immunogenicity and safety of high-dose trivalent inactivated influenza vaccine compared to standard-dose vaccine in children and young adults with cancer or HIV infection.
abstract: Approaches to improve the immune response of immunocompromised patients to influenza vaccination are needed.
  
  
  
  Children and young adults (3-21 years) with cancer or HIV infection were randomized to receive 2 doses of high-dose (HD) trivalent influenza vaccine (TIV) or of standard-dose (SD) TIV. Hemagglutination inhibition (HAI) antibody titers were measured against H1, H3, and B antigens after each dose and 9 months later. Seroconversion was defined as ≥4-fold rise in HAI titer comparing pre- and post-vaccine sera. Seroprotection was defined as a post-vaccine HAI titer ≥1:40. Reactogenicity events (RE) were solicited using a structured questionnaire 7 and 14 days after each dose of vaccine, and adverse events by medical record review for 21 days after each dose of vaccine.
  
  
  
  Eighty-five participants were enrolled in the study; 27 with leukemia, 17 with solid tumor (ST), and 41 with HIV. Recipients of HD TIV had significantly greater fold increase in HAI titers to B antigen in leukemia group and to H1 antigen in ST group compared to SD TIV recipients. This increase was not documented in HIV group. There were no differences in seroconversion or seroprotection between HD TIV and SD TIV in all groups. There was no difference in the percentage of solicited RE in recipients of HD TIV (54% after dose 1 and 38% after dose 2) compared to SD TIV (40% after dose 1 and 20% after dose 2, p=0.27 and 0.09 after dose 1 and 2, respectively).
  
  
  
  HD TIV was more immunogenic than SD TIV in children and young adults with leukemia or ST, but not with HIV. HD TIV was safe and well-tolerated in children and young adults with leukemia, ST, or HIV.
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA. Electronic address: Hana.Hakim@stjude.org.
authors.forename: Hana
authors.initials: H
authors.lastname: Hakim
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA.
authors.forename: Kim J
authors.initials: KJ
authors.lastname: Allison
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA.
authors.forename: Lee-Ann
authors.initials: LA
authors.lastname: Van de Velde
authors.affiliation: Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.
authors.forename: Li
authors.initials: L
authors.lastname: Tang
authors.affiliation: Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.
authors.forename: Yilun
authors.initials: Y
authors.lastname: Sun
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA; Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN, USA; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.
authors.forename: Patricia M
authors.initials: PM
authors.lastname: Flynn
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA; Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN, USA. Electronic address: jmccullers@uthsc.edu.
authors.forename: Jonathan A
authors.initials: JA
authors.lastname: McCullers
mesh_terms: D000293:Adolescent; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D005260:Female; D015658:HIV Infections / Q000276:immunology*; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007117:Immunization, Secondary; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000627:therapeutic use*; D007251:Influenza, Human / Q000517:prevention & control*; D007938:Leukemia / Q000276:immunology; D008297:Male; D009369:Neoplasms / Q000276:immunology*; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines
keywords: Cancer; HIV; High dose; Immune response; Influenza vaccine; Safety