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Fluzone High-Dose is an FDA-approved high-dose inactivated influenza vaccine manufactured by Sanofi. It contains 60 µg of hemagglutinin (HA) per virus strain, which is four times the concentration found in standard-dose vaccines, designed to improve immune response in older adults and immunocompromised individuals. Yale University researchers evaluated a specific two-dose regimen of Fluzone High-Dose (administered 30 days apart) in the SHIVERING 2 trial (Study of High-Dose Influenza Vaccine Efficacy by Repeated Dosing in Gammopathy Patients). This Phase 2 study focused on patients with plasma cell dyscrasias, including multiple myeloma, Waldenström macroglobulinemia, AL amyloidosis, and monoclonal gammopathy of undetermined significance (MGUS). The vaccine works by inducing neutralizing antibodies against the hemagglutinin surface proteins of influenza A and B viruses. The Yale-led study demonstrated that a tandem high-dose strategy provides superior and more durable seroprotection compared to the standard single-dose approach in this vulnerable population.
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