BiondVax Pharmaceuticals said that it has enrolled the first participant in the second cohort of a phase 3 trial of its M-001 universal flu vaccine candidate.
Close to 8,000 participants are being enrolled by BiondVax for the second cohort for the late-stage trial of M-001 in 85 sites across seven countries in eastern Europe. Israel-based BiondVax expects the results to come out by the end of next year.
A little under 4,100 people were enrolled in the trial’s first cohort before the 2018/19 flu season, and following review of the safety profile, the Data Safety Monitoring Board (DSMB) allowed BiondVax to move ahead with the second cohort.
Overall, the placebo-controlled clinical efficacy, phase 3 trial will evaluate safety and effectiveness of the M-001 vaccine alone in reducing flu illness and severity in nearly 12,000 adults aged 50 years and older, with at least half of them, aged 65 and older.
According to BiondVax, the M-001 universal flu vaccine candidate is designed to improve upon the presently available strain-specific vaccines in the markets in various ways. The vaccine candidate has been designed as a common denominator to influenza viruses, said the Israeli pharma company.
BiondVax said that results from six completed clinical studies indicate the vaccine candidate induces an immune response to a wide variety of influenza strains. The company claimed that the single formulation of M-001 facilitates year-round production, stockpiling, and vaccination.
BiondVax chief science officer Tamar Ben-Yedidia said: “Different flu strains circulate with varying frequency across seasons and countries. The Phase 3 trial of our universal flu vaccine is being conducted for two flu seasons over a broad geographic area, and vaccination began this year in July, well before the usual onset of flu season.
“The current study aims to demonstrate how well M-001 protects the participants against flu illness when they are exposed to any circulating flu strain.”
According to BiondVax, its vaccine candidate can give multi-strain and multi-season protection against present and future, seasonal and pandemic influenza. The company’s technology is said to use a combination of conserved and common influenza virus peptides intended to stimulate the two arms of the immune system to provide a cross-protecting and long-lasting effect.