In the clinical trial it was found, in a statistically significant manner when compared with placebo, that the highest immunogenicity was observed when using the highest dose of the Multimeric-001 Universal Flu Vaccine with adjuvant, which was injected twice to the participants. Similarly, it was found that in the dose given twice without adjuvant, there was a statistically significant response.
This trial is the first of two Phase I/II clinical trials of the Multimeric-001 Universal Flu Vaccine being conducted by BiondVax - the second trial has already commenced with 60 participants aged 55-75, and is expected to be completed in the first quarter of 2010.
Dr. Ron Babecoff, BiondVax CEO, notes that "We are very proud of the success of the Phase I/II clinical trial for the Multimeric-001 Universal Flu Vaccine, and of this initial proof of the immunogenicity and safety of our vaccine. The results obtained in this trial are an important indication of a significant milestone towards the realization of the Company's vision of ensuring protection against all flu strains through the use of a single vaccine. Such a vaccine is expected to do away with the need for annual vaccinations every year as required by current existing vaccines."
Dr. Tamar Ben Yedidia, BiondVax's Director of R&D, notes that, "the success of the trial proved that the Multimeric-001 Universal Flu Vaccine is safe to use and activates both arms of the human immune system. This is an important achievement, which will continue to be tested thoroughly in further clinical trials that will be conducted".
Dr. Ben Yedidia will be presenting this data at the World Influenza Congress in Brussels, Belgium, on 8 December 2009, in a presentation entitled "Delivering an Epitope-based Approach to Universal Influenza Vaccine Development".
SOURCE BiondVax Pharmaceuticals Ltd.