- 60 people, males and females, aged 18-49, participated in the trial
- The antibodies generated by the vaccine specifically identified several strains of influenza, including the swine flu strain
- BiondVax's CEO Dr. Ron Babecoff: "This is an important indication along the way towards the realization of the Company's vision of ensuring protection against all flu strains with a single vaccination."
BiondVax Pharmaceuticals Ltd. (TASE: BNDK), an Israeli biopharmaceutical company at the forefront of the development of a Universal Influenza Vaccine, announced the success of the Phase I/II clinical trial of the Company's Multimeric-001 Universal Flu Vaccine, in trials conducted at the Sourasky Medical Center in Tel Aviv, Israel. The Phase I/II 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 BiondVax's Multimeric-001 Universal Flu Vaccine is safe to use at all doses tested, both with and without adjuvant.
In addition, it was found that the Multimeric-001 Universal Flu 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 Multimeric-001 Universal Flu Vaccine. These antibodies also specifically identified a number of different strains of influenza, including the swine flu strain (A/H1N1).
In this Phase I/II clinical trial, certain cellular parameters were examined, and it was found that the Multimeric-001 Universal Flu 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 BiondVax's Multimeric-001 Universal Flu Vaccine from existing seasonal flu vaccines, which are characterised mainly by their ability to stimulate a humoral (antibody) response.
Furthermore, it was found that BiondVax's Multimeric-001 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. This is in contrast to other universal vaccines that are currently under development, which, to the Company's best knowledge based on scientific publications and other sources, are intended to provide protection against Type A influenzas only.