In the trial, conducted at the Sourasky Medical Center in Tel Aviv, a total of 60 male and female participants, aged 55-75, received two intramuscular injections containing the vaccine, either with or without adjuvant, and at two different dose levels. This was followed by an administration of a commercially available seasonal influenza vaccine.
In this second clinical trial, as in the first (which was conducted with a younger population), the results show that BiondVax’s Multimeric-001 Universal Flu Vaccine is safe and well-tolerated at all doses tested, both with and without adjuvant, and that the vaccine successfully activated the two arms of the human immune system – the humoral (antibody) arm and the cellular arm.
In light of the successful conclusion of the two Phase I/II clinical trials, BiondVax is preparing, as planned, to enter into Phase II clinical trials in the second half of 2010. BiondVax will be financing this trial itself.