STOP-FLU (high-dose influenza vaccine)
Trial question
What is the role of high-dose influenza vaccine in patients with solid organ transplant recipients?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 407
407 patients (118 female, 289 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=203 high-dose vaccine (Fluzone-HD vaccine, a trivalent non-adjuvanted influenza vaccine containing 60 mcg of hemagglutinin antigen per strain).
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
66%
42%
66.0 %
49.5 %
33.0 %
16.5 %
0.0 %
High-dose
vaccine
Standard
vaccine
Significant
increase ▲
NNT = 4
Significant increase in vaccine response rate at day 28 (66% vs. 42%; AD 0.24%, 95% CI 0.16 to 1).
Safety outcomes
No significant difference in allograft-related adverse outcome.
Conclusion
In adult solid organ transplant recipients > 3 months after transplantation, high-dose 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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