Trial in line with BiondVax clinical plan for Phase 3 trial in 2017/18
Nes Ziona, Israel – October 21, 2015 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) announced today that it has successfully recruited the first two participants in this trial, BVX-007. The trial is being conducted in Budapest, Hungary at the St Istvan and St Lazslo Hospital, as well as additional satellite sites in Hungary, together with the partners from the UNISEC European Consortium.
This phase IIb trial will include 222 adults. It is designed to evaluate the safety and immunogenicity of the Universal influenza vaccine when used ahead of an avian influenza vaccine (provided by FluArt, Hungary). The avian influenza vaccine will be given only once, at a sub-optimal dose, aiming to show the dose sparing potential of the universal vaccine when given prior to the avian vaccine, a highly desirable feature in a pandemic scenario, where existing stockpiles of vaccine may not be sufficient.
Eligibility criteria for the trial include participants aged 18-60 years in good health that do not suffer from immune deficiencies and were not vaccinated against Influenza in the 6 months prior to the trial. Results are expected in the second half of 2016.
Tamar Ben-Yedidia, CSO of BiondVax commented, “The trial will provide insight into the ability of BiondVax’s universal vaccine to stimulate broad immunity to influenza viruses including the highly pathogenic H5N1 bird flu virus. It is clear that a universal vaccine for influenza, that will also cover this aggressive and particularly dangerous strain is greatly needed.”