BiondVax Pharmaceuticals reported the first participant's initial visit in a pivotal clinical efficacy Phase 3 trial of the M-001 universal flu vaccine candidate. The primary endpoints of the trial are to demonstrate protection from influenza and safety of M-001. A secondary endpoint will assess reduction in flu illness severity among those receiving M-001 versus placebo.
In six completed clinical trials in Israel and Europe (two Phase 1/2 and four Phase 2), M-001 has been shown to be safe, well-tolerated, and immunogenic to a broad range of influenza strains. An additional Phase 2 trial in the USA, sponsored and conducted by the US National Institutes of Health (NIH), is ongoing.
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"We are very excited to reach this milestone for our M-001 universal flu vaccine candidate. I wish to thank our many partners who have supported us, and the BiondVax team, as we reach this pivotal moment,” Dr. Ron Babecoff, BiondVax's Founder and CEO, said. “Our goal has remained consistent from the beginning - to reduce the human burden of influenza. I hope this major step brings us closer to providing improved worldwide protection from the flu."
The study, titled "A Pivotal Multi-center, Randomized, Modified Double-blind, Placebo-controlled Phase 3 Trial to Assess the Safety and Clinical Efficacy of M-001 Influenza Vaccine Administered Intramuscularly Twice in Older Adults and Elderly (≥50 Years)", plans to enroll 9,630 participants from several eastern European countries over two flu seasons. Participants will be aged 50 years and over, with at least half aged 65 years and over. The study design includes a flexible enrollment regimen to adjust for variability in seasonal flu incidence, meaning the total number of participants may be more than 9,630 if flu incidence is lower than expected.
Participants will receive either two doses of M-001 or two doses of placebo approximately 21 days apart. Cohort One of the study, consisting of 4,333 participants, will be enrolled by November 2018. These participants will receive the vaccine or placebo regimen once and be monitored for two flu seasons. Cohort Two, with 5,297 participants, will be enrolled prior to the 2019/20 flu season. These participants will be monitored for one flu season. Participants will only receive M-001 or placebo, without any other flu vaccines, in order to assess M-001's clinical efficacy as a standalone universal flu vaccine.
Participants will be contacted twice weekly throughout the flu season to monitor for influenza-like illness (ILI). When an ILI is reported, nasal and throat swabs will be collected by specially trained medical personnel. Swab samples will be sent to a central laboratory to confirm presence of influenza virus.
Following guidance provided by the European Medicines Agency (EMA), following the first flu season BiondVax is permitted to assess the total number of laboratory confirmed influenza cases, in order to adjust, if necessary, the number of Cohort 2 participants. Final study results are expected by Q4 2020.
As previously reported, the EMA's Committee for Medicinal Products for Human Use (CHMP) reviewed the trial design and allowed BiondVax to proceed. Regulatory authorities in countries in which the trial is being conducted have also allowed the trial to proceed. Participants are volunteers and have provided informed consent.