title: Improved immunogenicity with high-dose seasonal influenza vaccine in HIV-infected persons: a single-center, parallel, randomized trial.
abstract: BACKGROUND
  HIV-infected persons have less robust antibody responses to influenza vaccines.
  
  
  OBJECTIVE
  To compare the immunogenicity of high-dose influenza vaccine with that of standard dosing in HIV-positive participants.
  
  
  METHODS
  Randomized, double-blind, controlled trial. (ClinicalTrials.gov: NCT01262846)
  
  
  METHODS
  The MacGregor Clinic of the Hospital of the University of Pennsylvania, Philadelphia, from 27 October 2010 to 27 March 2011.
  
  
  METHODS
  HIV-infected persons older than 18 years.
  
  
  METHODS
  Participants were randomly assigned to receive either a standard dose (15 mcg of antigen per strain) or a high dose (60 mcg/strain) of the influenza trivalent vaccine.
  
  
  METHODS
  The primary end point was the rate of seroprotection, defined as antibody titers of 1:40 or greater on the hemagglutination inhibition assay 21 to 28 days after vaccination. The primary safety end point was frequency and intensity of adverse events. Secondary end points were seroconversion rate (defined as a greater than 4-fold increase in antibody titers) and the geometric mean antibody titer.
  
  
  RESULTS
  195 participants enrolled, and 190 completed the study (93 in the standard-dose group and 97 in the high-dose group). The seroprotection rates after vaccination were higher in the high-dose group for the H1N1 (96% vs. 87%; treatment difference, 9 percentage points [95% CI, 1 to 17 percentage points]; P = 0.029), H3N2 (96% vs. 92%; treatment difference, 3 percentage points [CI, -3 to 10 percentage points]; P = 0.32), and influenza B (91% vs. 80%; treatment difference, 11 percentage points [CI, 1 to 21 percentage points]; P = 0.030) strains. Both vaccines were well-tolerated, with myalgia (19%), malaise (14%), and local pain (10%) the most frequent adverse events.
  
  
  CONCLUSIONS
  The effectiveness of the vaccine in preventing clinical influenza was not evaluated. The number of participants with CD4 counts less than 0.200 × 109 cells/L was limited.
  
  
  CONCLUSIONS
  HIV-infected persons reach higher levels of influenza seroprotection if vaccinated with the high-dose trivalent vaccine than with the standard-dose.
  
  
  BACKGROUND
  National Institute of Allergy and Infectious Diseases and Center for AIDS Research of the University of Pennsylvania.
authors.affiliation: University of Pennsylvania, Philadelphia, PA 19104, USA.
authors.forename: Noah
authors.initials: N
authors.lastname: McKittrick
authors.forename: Ian
authors.initials: I
authors.lastname: Frank
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Jacobson
authors.forename: C Jo
authors.initials: CJ
authors.lastname: White
authors.forename: Deborah
authors.initials: D
authors.lastname: Kim
authors.forename: Rosemarie
authors.initials: R
authors.lastname: Kappes
authors.forename: Carol
authors.initials: C
authors.lastname: DiGiorgio
authors.forename: Thomas
authors.initials: T
authors.lastname: Kenney
authors.forename: Jean
authors.initials: J
authors.lastname: Boyer
authors.forename: Pablo
authors.initials: P
authors.lastname: Tebas
mesh_terms: D000328:Adult; D000917:Antibody Formation; D018791:CD4 Lymphocyte Count; D004311:Double-Blind Method; D005260:Female; D006679:HIV Seropositivity / Q000276:immunology*; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D016867:Immunocompromised Host; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D014611:Vaccination; D019562:Viral Load; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines