Background: Current influenza vaccines, based on antibodies against surface antigens, are unable to provide\nprotection against newly emerging virus strains which differ from the vaccine strains. Therefore the population has to be\nre-vaccinated annually. It is thus important to develop vaccines which induce protective immunity to a broad spectrum\nof influenza viruses. This trial is designed to evaluate the immunogenicity and safety of FLU-v, a vaccine composed of\nfour synthetic peptides with conserved epitopes from influenza A and B strains expected to elicit both cell mediated\nimmunity (CMI) and humoral immunity providing protection against a broad spectrum of influenza viruses.\nMethods: In a single-center, randomized, double-blind and placebo-controlled phase IIb trial, 222 healthy volunteers\naged 18ââ?¬â??60 years will be randomized (2:2:1:1) to receive two injections of a suspension of 500 Ã?¼g FLU-v in saline (arm 1),\none dose of emulsified 500 Ã?¼g FLU-v in Montanide ISA-51 and water for injection (WFI) followed by one saline dose\n(arm 2), two saline doses (arm 3), or one dose of Montanide ISA-51 and WFI emulsion followed by one saline\ndose (arm 4). All injections will be given subcutaneously. Primary endpoints are safety and FLU-v induced CMI,\nevaluated by cytokine production by antigen specific T cell populations (flow-cytometry and ELISA). Secondary\noutcomes are measurements of antibody responses (ELISA and multiplex), whereas exploratory outcomes include\nclinical efficacy and additional CMI assays (ELISpot) to show cross-reactivity.\nDiscussion: Broadly protective influenza vaccines able to provide protection against multiple strains of influenza are\nurgently needed. FLU-v is a promising vaccine which has shown to trigger the cell-mediated immune response. The\ndosages and formulations tested in this current trial are also estimated to induce antibody response. Therefore, both\ncellular and humoral immune responses will be evaluated.
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