STOP-FLU (MF59-adjuvanted influenza vaccine)
Trial question
What is the role of MF59-adjuvanted influenza vaccine in patients with solid organ transplant recipients?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 413
413 patients (115 female, 298 male)
Inclusion criteria: adult solid organ transplant recipients > 3 months after transplantation
Key exclusion criteria: hypersensitivity to any component of the study vaccines; previous life-threatening reaction to influenza vaccine; ongoing therapy for rejection; current treatment with immunoglobulins or eculizumab, rituximab therapy within six months; ABO-incompatible transplantation; pregnancy
Interventions
N=209 MF59-adjuvanted vaccine (Fluad vaccine, a trivalent influenza vaccine containing 15 mcg of hemagglutinin antigen per strain and the adjuvant MF59)
N=204 standard vaccine (Vaxigrip Tetra vaccine, a quadrivalent non-adjuvanted influenza vaccine containing 15 mcg of hemagglutinin antigen per strain)
Primary outcome
Vaccine response rate at day 28
60
42
60.0 %
45.0 %
30.0 %
15.0 %
0.0 %
MF59-adjuvanted
vaccine
Standard
vaccine
Significant
increase ▲
NNT = 5
Significant increase in vaccine response rate at day 28 (60% vs. 42%; AD 0.17%, 97.5% CI 0.08 to 1)
Safety outcomes
No significant difference in allograft-related adverse outcome.
Conclusion
In adult solid organ transplant recipients > 3 months after transplantation, MF59-adjuvanted vaccine was superior to standard vaccine with respect to vaccine response rate at day 28.
Reference
Matteo Mombelli, Dionysios Neofytos, Uyen Huynh-Do et al. Immunogenicity of High-Dose vs. MF59-adjuvanted vs. Standard Influenza Vaccine in Solid Organ Transplant Recipients: The STOP-FLU trial. Clin Infect Dis. 2024 Jan 25;78(1):48-56.
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