BiondVax Pharmaceuticals Completes Flu Vaccine Clinical Trial

BiondVax Pharmaceuticals, an Israeli biopharmaceutical company, has announced the success of the Phase I/II clinical trial of the company's Multimeric-001 universal flu vaccine, in trials that were conducted at the Sourasky Medical Center in Tel Aviv, Israel.

The trial was a randomized, single-blind, placebo-controlled, escalating double-dose safety study in which a total of 60 participants, males and females aged 18-49, received two intramuscular injections containing the Multimeric-001 vaccine, either with or without adjuvant, and at two different dose levels.

The clinical trial results show that the vaccine is safe to use at all doses tested, both with and without adjuvant.

It was found that the vaccine activated, in a statistically significant manner when compared with placebo, the two arms of the human immune system - the humoral (antibody) arm and the cellular arm. All participants who received the vaccine showed a high level of antibodies against the vaccine. These antibodies also specifically identified a number of different strains of influenza, including the swine flu strain (A/H1N1).

It was found that the vaccine caused, in a statistically significant manner when compared with placebo, a meaningful increase in the white blood cells of the immune system, inducing the secretion of Interferon Gamma and Interleukin-2, substances secreted by the immune system as part of the body's cellular defense against pathogens. This cellular response distinguishes the Multimeric-001 from existing seasonal flu vaccines, which are characterized mainly by their ability to stimulate a humoral (antibody) response.

It was found that the universal flu vaccine stimulated both humoral (antibody) and cellular responses against the two types of influenza: Influenza Type A and Influenza Type B, the types of flu which cause the flu disease in humans.

The second trial has already commenced with 60 participants aged 55-75, and is expected to be completed in the first quarter of 2010.