학술논문
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).
Document Type
Article
Author
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
Source
Subject
*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
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Language
ISSN
1058-4838
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. [ABSTRACT FROM AUTHOR]