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news.BiondVax Pharmaceuticals' randomized, double-blind, placebo-controlled Phase IIa trial of Multimeric-001 Universal Influenza Vaccine has met primary safety, immunogenicity and secondary immunogenicity endpoints.
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The trial results demonstrated that the vaccine was safe and well tolerated through out the study which involved around 200 healthy volunteers.
The vaccine, when used in combination with an available strain-dependant seasonal influenza vaccine (trivalent inactivated vaccine, or TIV), enhanced the performance of the TIV by increasing the rates of Hemagglutination Inhibition (HI) seroconversion to influenza strains both included, and not-included, in the TIV itself.
The vaccine also induced both humoral (antibody) and cell-mediated immune responses, further confirming previous results from the Phase I/II clinical trials.
Currently, the company plans to initiate the next Phase II trial in the fourth quarter of 20011, in the elderly people.
BiondVax CEO Ron Babecoff said they have confirmed that the Multimeric-001 vaccine is not only safe and immunogenic on its own, but it also has the potential to enhance the performance of traditional strain-dependant flu vaccines.