BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) announced today that it received regulatory clearance from the Hungarian Regulatory Authority (National Institute of Pharmacology and Nutrition, OGYEI) and the Central Ethics Committee in Budapest to initiate a Phase IIb clinical trial. The initiation meeting was scheduled for today, September 30, 2015, together with the partners from the UNISEC European Consortium.
This phase IIb trial is a multicenter, randomized, double-blind, active-controlled trial. It is being conducted under the auspicies of an EU-funded UNISEC project, assessing the immunogenicity and safety of BiondVax's universal influenza vaccine (Multimeric-001), followed by an administration of the H5N1 influenza vaccine. The trial will include 222 healthy adults aged 18-60 years, a group representing the target population for receiving vaccines when a pandemic outbreak occurs.
The trial is primarily being conducted at the St. Istvan and St. Laszlo Hospital in Budapest, Hungary as well as additional satellite sites in the country. Recruitment of participants for the trial has started, and results are expected in the second half of 2016.
Utilizing the clinical trial network and specialised laboritories of UNISEC's consortium, BiondVax is initiating this clinical study to examine the benefits of priming with BiondVax's universal flu vaccine. This new approach enables public health authorities to be proactive and prepared in advance of any flu pandemic outbreak, by building a national stockpile of the universal flu vaccine. This allows vaccinations to start immediately upon any pandemic outbreak, compared to the current-day situation, whereby there is a delay of approximately 6 months due to the manufacture of the pandemic strain specific vaccine. In addition, BiondVax has demonstrated in previous trials that using its vaccine as a primer provides additional protection against flu strains in the current TIV (current seasonal flu vaccine) as well as drifted strains not included in this vaccine.
The current trial is led by Prof. Dr. Eelko Hak, Trial Coordinator on behalf of the UNISEC consortium from the University of Groningen, Netherlands and Dr. Zsofia Meszner, General Director of the National Institute of Child Health from St. Istvan and St. Laszlo Hospital, as Principle Investigator and Dr. Dora Mathiazs the Strategic Director of the hospital. BiondVax, as well as other partners of the UNISEC consortium including RKI, Berlin and NCE, Budapest, will be involved in the immunogenicity testing of the cellular and humoral responses.
To date, BiondVax has successfully completed five clinical trials (two phase I/II and three phase II), conducted with 479 participants for its Universal Flu Vaccine. The vaccine was found safe, effective, and capable of triggering both cellular and humoral responses of the human immune system, against different strains of the influenza virus including existing and future strains.
Tamar Ben-Yedidia, CSO of BiondVax commented, "I am pleased to see our clinical program taking a significant step forward. This marks our progression to the international phase of our clinical development program, with trials now starting in Europe and soon in the United States in collaboration with the NIAID/NIH as we recently announced."