A Double-Blind, Randomized Trial of High-Dose vs Standard-Dose Influenza Vaccine in Adult Solid-Organ Transplant Recipients

Yoichiro Natori, Mika Shiotsuka, Jaclyn Slomovic, Katja Hoschler, Victor Ferreira, Peter Ashton, Coleman Rotstein, Les Lilly, Jeffrey Schiff, Lianne Singer, Atul Humar, Deepali Kumar*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

90 Citations (Scopus)


Background The annual standard-dose (SD) influenza vaccine has suboptimal immunogenicity in solid organ transplant recipients (SOTRs). Influenza vaccine that contains higher doses of antigens may lead to greater immunogenicity in this population. Methods We conducted a randomized, double-blind trial to compare the safety and immunogenicity of the 2016-2017 high-dose (HD; FluzoneHD, Sanofi) vs SD (Fluviral, GSK) influenza vaccine in adult SOTRs. Preimmunization and 4-week postimmunization sera underwent strain-specific hemagglutination inhibition assay. Results We enrolled 172 patients who received study vaccine, and 161 (84 HD; 77 SD) were eligible for analysis. Seroconversion to at least 1 of 3 vaccine antigens was present in 78.6% vs 55.8% in HD vs SD vaccine groups (P <.001), respectively. Seroconversions to A/ H1N1, A/H3N2, and B strains were 40.5% vs 20.5%, 57.1% vs 32.5%, and 58.3% vs 41.6% in HD vs SD vaccine groups (P =.006, P =.002, P =.028, respectively). Post-immunization geometric mean titers of A/H1N1, A/H3N2, and B strains were significantly higher in the HD group (P =.007, P =.002, P =.033). Independent factors associated with seroconversion to at least 1 vaccine strain were the use of HD vaccine (odds ratio [OR], 3.23; 95% confidence interval [CI], 1.56-6.67) and use of mycophenolate doses <2 g daily (OR, 2.76; 95% CI, 1.12-6.76). Conclusions HD vaccine demonstrated significantly better immunogenicity than SD vaccine in adult transplant recipients and may be the preferred influenza vaccine for this population. Clinical Trials Registration NCT03139565.

Original languageEnglish
Pages (from-to)1698-1704
Number of pages7
JournalClinical Infectious Diseases
Issue number11
Publication statusPublished - 17 May 2018

Bibliographical note

Funding Information:
Financial support. The study was partially funded by the Multi-Organ Transplant Program. FluzoneHD was purchased from Sanofi, Canada. Fluviral was obtained from the Ontario public health supply.

Publisher Copyright:
© The Author(s) 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved.

Copyright 2018 Elsevier B.V., All rights reserved.


  • immunocompromised
  • immunogenicity
  • immunosuppression
  • seroconversion
  • seroprotection


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