STOP-FLU - Reducing the Burden of Influenza after Solid-Organ Transplantation:
Design: Prospective double-blinded randomized controlled three-arm parallel group superiority multicenter trial.
Status: Recruiting and ongoing.
Influenza is associated with significant morbidity and mortality in solid-organ transplant (SOT) recipients and it is mainly prevented by seasonal influenza vaccination. Unfortunately, the immunogenicity of standard influenza vaccine is suboptimal in this population. Vaccination with a high-dose (HD) influenza vaccine or an MF59-adjuvanted (MF59a) vaccine have significantly reduced the incidence of influenza and increased the immunogenicity of influenza vaccine in the elderly. The investigators will compare the immunogenicity and efficacy of two new vaccination strategies, consisting in vaccination with a HD influenza vaccine or an MF59a influenza vaccine, to the standard-dose non-adjuvanted vaccination (standard of care) in a population of SOT recipients.
The Vaccine and Immunotherapy Centre is providing operational support for the STOP-FLU clinical trial