1. 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)
- Author
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Swiss National Science Foundation, Sánchez-Céspedes, Javier [0000-0003-2707-1979], Mombelli, Matteo, Neofytos, Dionysios, Huynh-Do, Uyen, Sánchez-Céspedes, Javier, Stampf, Susanne, Golshayan, Dela, Dahdal, Suzan, Stirnimann, Guido, Schnyder, Aurelia, Garzoni, Christian, Venzin, Reto M., Magenta, Lorenzo, Schönenberger, Melanie, Walti, Laura, Hirzel, Cédric, Munting, Aline, Dickenmann, Michael, Koller, Michael, Aubert, John-David, Steiger, Jürg, Pascual, Manuel, Mueller, Thomas F., Schuurmans, Macé, Berger, Christoph, Binet, Isabelle, Villard, Jean, Mueller, Nicolas J., Egli, Adrian, Cordero, Van Delden, Christian, Manuel, Oriol, Swiss National Science Foundation, Sánchez-Céspedes, Javier [0000-0003-2707-1979], Mombelli, Matteo, Neofytos, Dionysios, Huynh-Do, Uyen, Sánchez-Céspedes, Javier, Stampf, Susanne, Golshayan, Dela, Dahdal, Suzan, Stirnimann, Guido, Schnyder, Aurelia, Garzoni, Christian, Venzin, Reto M., Magenta, Lorenzo, Schönenberger, Melanie, Walti, Laura, Hirzel, Cédric, Munting, Aline, Dickenmann, Michael, Koller, Michael, Aubert, John-David, Steiger, Jürg, Pascual, Manuel, Mueller, Thomas F., Schuurmans, Macé, Berger, Christoph, Binet, Isabelle, Villard, Jean, Mueller, Nicolas J., Egli, Adrian, Cordero, Van Delden, Christian, and Manuel, Oriol
- 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.
- Published
- 2024