BiondVax Pharmaceuticals has signed a master service agreement (MSA) with an undisclosed contract research organisation (CRO) to conduct a Phase III clinical trial of its universal flu vaccine M-001.
The trial is scheduled to start later this year, before the beginning of the 2018/19 Northern Hemisphere flu season.
It will enrol 9,630 participants aged over 50 years across four to six countries in eastern Europe.
The design of the trial, which expects to follow participants for up to two flu seasons, has been approved by European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
BiondVax chief science officer Dr Tamar Ben-Yedidia said: “Having worked on our universal flu vaccine since the very beginning and ushering it through many years of R&D and clinical trials, I am particularly proud to reach this exciting milestone.
“As far as we know, this is the world’s most clinically advanced universal flu vaccine. This winter’s flu season shows us once again the urgent need for an improved flu vaccine.
“I hope our vaccine will contribute to significant reduction of the economic and social burden of influenza.”
Originally conceived in the lab of Israel’s Weizmann Institute of Science professor Ruth Arnon, M-001 features nine epitopes common to the vast majority of influenza virus strains, including both influenza Type A and B.
The vaccine has so far been tested in six clinical trials and was found to be safe, well-tolerated, and immunogenic to various influenza strains.