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).

Autor:	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
Předmět:	INFLUENZA prevention INFLUENZA vaccines HEMAGGLUTINATION tests CONFIDENCE intervals VACCINE immunogenicity PATIENTS VACCINE effectiveness RANDOMIZED controlled trials COMPARATIVE studies DESCRIPTIVE statistics RESEARCH funding POLYMERASE chain reaction STATISTICAL sampling TRANSPLANTATION of organs tissues etc. EVALUATION
Zdroj:	Clinical Infectious Diseases; 1/15/2024, Vol. 78 Issue 1, p48-56, 9p
Abstrakt:	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. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
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