The second Phase I/II trial was a randomised, single-blind, placebo-controlled, escalating double-dose safety study conducted at the Sourasky Medical Center in Tel Aviv, Israel, in which a total of 60 participants, males and females aged 55-75, received two intramuscular injections containing the vaccine, either with or without adjuvant, and at two different dose levels. This was then followed by an administration of a commercially available seasonal influenza vaccine.
In the first trial, which was concluded in December 2009, with 63 participants aged 18-49, the vaccine was shown to be safe and to effectively activate both humoral (antibody) and cellular arms of the human immune system.
In the second clinical trial, as in the first, 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.
BiondVax Pharmaceuticals said that despite the fact that the immune systems of the older group participating in this second trial are naturally weaker than those of the younger group that participated in the first trial, it was again found that the Multimeric-001 Universal Flu Vaccine activated the two arms of the human immune system – the humoral (antibody) arm and the cellular arm.
The study results suggested that from a humoral immunity perspective, all participants who received the vaccine showed an increase in the level of antibodies against the Multimeric-001 Universal Flu Vaccine.
However, from a cellular immunity perspective, it was again found that the Multimeric-001 Universal Flu Vaccine caused an elevation in the secretion of Interferon Gamma and Interleukin-2, substances that have an anti-viral effect.
BiondVax Pharmaceuticals is preparing to enter into Phase II clinical trials for the Multimeric-001 vaccine. The trial is expected to be conducted in two centers in Israel, with around 160 participants 18-49 years old. This trial is expected to commence in the second half of 2010.
Ron Babecoff, CEO of BiondVax Pharmaceuticals, said: “In two studies, in both younger and older adult population groups, we have shown that our vaccine is safe and well tolerated, and successfully activates both arms of the immune system.
“We are especially gratified by the positive results found in the older population group, which exceeded our expectations, as this is a group in which the immune system response is more difficult to stimulate than in younger adults. We are confident that we now have a strong clinical candidate with which to advance to Phase II trials.”