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Randomized Controlled Trial
. 2024 Jan 25;78(1):48-56.
doi: 10.1093/cid/ciad477.

Immunogenicity of High-Dose Versus MF59-Adjuvanted Versus Standard Influenza Vaccine in Solid Organ Transplant Recipients: The Swiss/Spanish Trial in Solid Organ Transplantation on Prevention of Influenza (STOP-FLU Trial)

Matteo Mombelli  1   2 , Dionysios Neofytos  3 , Uyen Huynh-Do  4 , Javier Sánchez-Céspedes  5   6   7 , Susanne Stampf  8 , Dela Golshayan  1 , Suzan Dahdal  4 , Guido Stirnimann  9 , Aurelia Schnyder  10 , Christian Garzoni  11 , Reto M Venzin  12 , Lorenzo Magenta  13 , Melanie Schönenberger  8 , Laura Walti  14 , Cédric Hirzel  14 , Aline Munting  2 , Michael Dickenmann  8 , Michael Koller  8 , John-David Aubert  1   15 , Jürg Steiger  8 , Manuel Pascual  1 , Thomas F Mueller  16 , Macé Schuurmans  17 , Christoph Berger  18 , Isabelle Binet  10 , Jean Villard  19 , Nicolas J Mueller  20 , Adrian Egli  21   22   23 , Elisa Cordero  5   6   7 , Christian van Delden  3 , Oriol Manuel  1   2
Affiliations
Randomized Controlled Trial

Immunogenicity of High-Dose Versus MF59-Adjuvanted Versus Standard Influenza Vaccine in Solid Organ Transplant Recipients: The Swiss/Spanish Trial in Solid Organ Transplantation on Prevention of Influenza (STOP-FLU Trial)

Matteo Mombelli et al. Clin Infect Dis. .

Abstract

Background: The immunogenicity of the standard influenza vaccine is reduced in solid-organ transplant (SOT) recipients, so new vaccination strategies are needed in this population.

Methods: Adult SOT recipients from 9 transplant clinics in Switzerland and Spain were enrolled if they were >3 months after transplantation. Patients were randomized (1:1:1) to a MF59-adjuvanted or a high-dose vaccine (intervention), or a standard vaccine (control), with stratification by organ and time from transplant. The primary outcome was vaccine response rate, defined as a ≥4-fold increase of hemagglutination-inhibition titers to at least 1 vaccine strain at 28 days postvaccination. Secondary outcomes included polymerase chain reaction-confirmed influenza and vaccine reactogenicity.

Results: A total of 619 patients were randomized, 616 received the assigned vaccines, and 598 had serum available for analysis of the primary endpoint (standard, n = 198; MF59-adjuvanted, n = 205; high-dose, n = 195 patients). Vaccine response rates were 42% (84/198) in the standard vaccine group, 60% (122/205) in the MF59-adjuvanted vaccine group, and 66% (129/195) in the high-dose vaccine group (difference in intervention vaccines vs standard vaccine, 0.20; 97.5% confidence interval [CI], .12-1); P < .001; difference in high-dose vs standard vaccine, 0.24 [95% CI, .16-1]; P < .001; difference in MF59-adjuvanted vs standard vaccine, 0.17 [97.5% CI, .08-1]; P < .001). Influenza occurred in 6% of the standard, 5% in the MF59-adjuvanted, and 7% in the high-dose vaccine groups. Vaccine-related adverse events occurred more frequently in the intervention vaccine groups, but most of the events were mild.

Conclusions: In SOT recipients, use of an MF59-adjuvanted or a high-dose influenza vaccine was safe and resulted in a higher vaccine response rate.

Clinical trials registration: Clinicaltrials.gov NCT03699839.

Keywords: immunocompromised; influenza; transplantation; vaccination.

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Conflict of interest statement

Potential conflicts of interest. O. M. reports receiving grants from Lophius Bioscience and participated in advisory boards of Takeda and MSD. N. J. M. reports receiving grants from the Swiss Transplant Cohort Study, receiving support for attending a meeting by Biotest, and participating in the board of the Swiss Society for Infectious Diseases. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Graphical Abstract
Graphical Abstract
This graphical abstract is also available at Tidbit: https://tidbitapp.io/tidbits/immunogenicity-of-high-dose-vs-mf59-adjuvanted-vs-standard-influenza-vaccine-in-solid-organ-transplant-recipients-the-stop-flu-trial
Figure 1.
Figure 1.
Trial profile.
See this image and copyright information in PMC

References

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