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

tetano

Editor, Senior Moderator
Clin Infect Dis. 2017 Dec 14. doi: 10.1093/cid/cix1082. [Epub ahead of print]
[h=1]A Double Blind Randomized Trial of High Dose vs. Standard Dose Influenza Vaccine in Adult Solid Organ Transplant Recipients.[/h] Natori Y[SUP]1[/SUP], Shiotsuka M[SUP]1[/SUP], Slomovic J[SUP]1[/SUP], Hoschler K[SUP]2[/SUP], Ferreira V[SUP]1[/SUP], Ashton P[SUP]1[/SUP], Rotstein C[SUP]1[/SUP], Lilly L[SUP]1[/SUP], Schiff J[SUP]1[/SUP], Singer L[SUP]1[/SUP], Humar A[SUP]1[/SUP], Kumar D[SUP]1[/SUP].
[h=3]Author information[/h]

[h=3]Abstract[/h] [h=4]Background:[/h] The annual standard dose influenza vaccine has suboptimal immunogenicity in solid organ transplant recipients (SOTR). Influenza vaccine containing higher doses of antigens may lead to greater immunogenicity in this population.
[h=4]Methods:[/h] We conducted a randomized, double blind trial comparing the safety and immunogenicity of the 2016-17 high dose (HD; FluzoneHD,Sanofi) versus standard dose (SD; Fluviral,GSK) influenza vaccine in adult SOTR. Preimmunization and 4-week postimmunization sera underwent strain-specific hemagglutination inhibition assay.
[h=4]Results:[/h] 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 respectively (p<0.001). Seroconversion 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 (p=0.006, 0.002, 0.028 respectively). Post-immunization geometric mean titers of A/H1N1, A/H3N2, and B strains were significantly higher in HD group (p=0.007, 0.002, 0.033). Independent factors associated with seroconversion to at least one vaccine strain were the use of HD vaccine (OR 3.23, 95% CI 1.56-6.67) and use of mycophenolate doses less than 2g daily (OR 2.76, 95% CI 1.12-6.76).
[h=4]Conclusions:[/h] High-dose vaccine demonstrated significantly better immunogenicity than SD vaccine in adult transplant recipients and may be the preferred influenza vaccine for this population.


[h=4]KEYWORDS:[/h] immunocompromised; immunogenicity; immunosuppression; seroconversion; seroprotection

PMID: 29253089 DOI: 10.1093/cid/cix1082
 
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