tetano
Editor, Senior Moderator
Clin Infect Dis
. 2023 Aug 16;ciad477.
doi: 10.1093/cid/ciad477. Online ahead of print. Immunogenicity of High-Dose vs. MF59-adjuvanted vs. Standard Influenza Vaccine in Solid Organ Transplant Recipients: The STOP-FLU trial
Matteo Mombelli[SUP] 1 2 [/SUP], Dionysios Neofytos[SUP] 3 [/SUP], Uyen Huynh-Do[SUP] 4 [/SUP], Javier Sánchez-Céspedes[SUP] 5 6 7 [/SUP], Susanne Stampf[SUP] 8 [/SUP], Dela Golshayan[SUP] 1 [/SUP], Suzan Dahdal[SUP] 4 [/SUP], Guido Stirnimann[SUP] 9 [/SUP], Aurelia Schnyder[SUP] 10 [/SUP], Christian Garzoni[SUP] 11 [/SUP], Reto M Venzin[SUP] 12 [/SUP], Lorenzo Magenta[SUP] 13 [/SUP], Melanie Schönenberger[SUP] 8 [/SUP], Laura Walti[SUP] 14 [/SUP], Cédric Hirzel[SUP] 14 [/SUP], Aline Munting[SUP] 2 [/SUP], Michael Dickenmann[SUP] 8 [/SUP], Michael Koller[SUP] 8 [/SUP], John-David Aubert[SUP] 1 15 [/SUP], Jürg Steiger[SUP] 8 [/SUP], Manuel Pascual[SUP] 1 [/SUP], Thomas F Mueller[SUP] 16 [/SUP], Macé Schuurmans[SUP] 17 [/SUP], Christoph Berger[SUP] 18 [/SUP], Isabelle Binet[SUP] 10 [/SUP], Jean Villard[SUP] 19 [/SUP], Nicolas J Mueller[SUP] 20 [/SUP], Adrian Egli[SUP] 21 22 23 [/SUP], Elisa Cordero[SUP] 5 6 7 [/SUP], Christian van Delden[SUP] 3 [/SUP], Oriol Manuel[SUP] 1 2 [/SUP]; Swiss Transplant Cohort Study
Affiliations
Background: The immunogenicity of the standard influenza vaccine is reduced in solid-organ transplant (SOT) recipients, so that new vaccination strategies are needed in this population.
Methods: Adult SOT recipients from nine transplant clinics in Switzerland and Spain were enrolled if they were >3 months after transplantation. High, 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 one vaccine strain at 28 days post-vaccination. Secondary outcomes included PCR-confirmed influenza and vaccine reactogenicity.
Results: 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% CI 0.12-1]; p<0.001; difference in high-dose vs. standard vaccine, 0.24 [95% CI 0.16-1]; p<0.001; difference in MF59-adjuvanted vs. standard vaccine, 0.17 [97.5% CI 0.08-1]; p<0.001). Influenza occurred in 6% 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.
Trial registration: Clinicaltrials.gov NCT03699839.
Keywords: Transplantation; immunocompromised; influenza; vaccination.
. 2023 Aug 16;ciad477.
doi: 10.1093/cid/ciad477. Online ahead of print. Immunogenicity of High-Dose vs. MF59-adjuvanted vs. Standard Influenza Vaccine in Solid Organ Transplant Recipients: The STOP-FLU trial
Matteo Mombelli[SUP] 1 2 [/SUP], Dionysios Neofytos[SUP] 3 [/SUP], Uyen Huynh-Do[SUP] 4 [/SUP], Javier Sánchez-Céspedes[SUP] 5 6 7 [/SUP], Susanne Stampf[SUP] 8 [/SUP], Dela Golshayan[SUP] 1 [/SUP], Suzan Dahdal[SUP] 4 [/SUP], Guido Stirnimann[SUP] 9 [/SUP], Aurelia Schnyder[SUP] 10 [/SUP], Christian Garzoni[SUP] 11 [/SUP], Reto M Venzin[SUP] 12 [/SUP], Lorenzo Magenta[SUP] 13 [/SUP], Melanie Schönenberger[SUP] 8 [/SUP], Laura Walti[SUP] 14 [/SUP], Cédric Hirzel[SUP] 14 [/SUP], Aline Munting[SUP] 2 [/SUP], Michael Dickenmann[SUP] 8 [/SUP], Michael Koller[SUP] 8 [/SUP], John-David Aubert[SUP] 1 15 [/SUP], Jürg Steiger[SUP] 8 [/SUP], Manuel Pascual[SUP] 1 [/SUP], Thomas F Mueller[SUP] 16 [/SUP], Macé Schuurmans[SUP] 17 [/SUP], Christoph Berger[SUP] 18 [/SUP], Isabelle Binet[SUP] 10 [/SUP], Jean Villard[SUP] 19 [/SUP], Nicolas J Mueller[SUP] 20 [/SUP], Adrian Egli[SUP] 21 22 23 [/SUP], Elisa Cordero[SUP] 5 6 7 [/SUP], Christian van Delden[SUP] 3 [/SUP], Oriol Manuel[SUP] 1 2 [/SUP]; Swiss Transplant Cohort Study
Affiliations
- PMID: 37584344
- DOI: 10.1093/cid/ciad477
Background: The immunogenicity of the standard influenza vaccine is reduced in solid-organ transplant (SOT) recipients, so that new vaccination strategies are needed in this population.
Methods: Adult SOT recipients from nine transplant clinics in Switzerland and Spain were enrolled if they were >3 months after transplantation. High, 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 one vaccine strain at 28 days post-vaccination. Secondary outcomes included PCR-confirmed influenza and vaccine reactogenicity.
Results: 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% CI 0.12-1]; p<0.001; difference in high-dose vs. standard vaccine, 0.24 [95% CI 0.16-1]; p<0.001; difference in MF59-adjuvanted vs. standard vaccine, 0.17 [97.5% CI 0.08-1]; p<0.001). Influenza occurred in 6% 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.
Trial registration: Clinicaltrials.gov NCT03699839.
Keywords: Transplantation; immunocompromised; influenza; vaccination.