BiondVax Pharmaceuticals has enrolled the first patient in a Phase lll trial to evaluate the safety and efficacy of M-001 for the treatment of influenza.
The pivotal, multi-centre, randomised, modified, double-blind, placebo-controlled trial is expected to enrol 9,630 subjects from various eastern European countries over two flu seasons.
During the trial, M-001 will be administered twice intramuscularly in subjects aged 50 and over, with at least half aged 65 and older.
The trial features a flexible enrolment regimen to include more than the planned number of patients if flu incidence is lower than expected.
It will include two patient cohorts, the first of which is expected to include 4,333 participants by November this year, while the second cohort is set to enrol 5,297 participants before the 2019/20 flu season.
Subjects in cohort one of the trial will receive the M-001 vaccine or placebo regimen once and will be observed for two flu seasons.
The cohort two participants will only receive M-001 or placebo, without any other flu vaccines, in order to evaluate M-001’s clinical efficacy as a standalone universal flu vaccine.
Over the course of the trial, the subjects will be contacted twice weekly throughout the flu season to monitor for influenza-like illness (ILI).
Once ILI is reported, nasal and throat swabs will be collected to test in a laboratory to confirm the presence of influenza virus.
The primary objectives of the trial are to demonstrate protection from influenza and safety of M-001.
The trial's secondary endpoint will evaluate reduction in flu illness severity among those receiving M-001 versus placebo.
Final results from the trial are expected by the last quarter of 2020.
In addition, M-001 was demonstrated to be safe, well-tolerated, and immunogenic to various influenza strains in six completed clinical trials held in Israel and Europe.