BiondVax Pharma (BVXV) announced today that enrollment of 224 participants in a Phase 2b clinical trial of M-001, its universal flu vaccine candidate, is complete. The trial, conducted in collaboration with the EU-sponsored UNISEC consortium, is designed to evaluate the safety and immunogenicity of M-001 when used ahead of an avian influenza vaccine. Among other goals the study aims to show the dose sparing potential of M-001 when given prior to avian vaccine, a highly desirable feature in a pandemic scenario, when existing stockpiles of vaccine may be insufficient.
Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientist, explained, “This important milestone, along with the NIH-sponsored Phase 2 trial in the USA, keeps BiondVax on track to be Phase 3 ready by 2017/18. We are excited to be one step closer to bringing our multi-strain and multi-season vaccine against seasonal and pandemic flu to the market.”
Prof. Dr. Eelko Hak, UNISEC clinical trial program work package leader, commented, “This important clinical trial is a major contribution to the mission of the European UNISEC consortium to learn more about the potential of these promising broadly reactive new vaccines.”
Results from this trial are expected late 2016 or early 2017.
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