Universal Flu Vaccine Passes First Hurdle

What potentially may become the first universal flu vaccine successfully passed its initial Phase I/II clinical trial and was demonstrated to be safe for use in humans.

The Multimeric-001 Universal Flu Vaccine, developed by BiondVax Pharmaceuticals (Rehovot, Israel), was tested in a randomized, single-blind, placebo-controlled, escalating double-dose safety study on a total of 60 participants, males and females aged 18-49. Each subject received two intramuscular injections containing the Multimeric-001 vaccine, either with or without adjuvant, and at two different dose levels.

Results of the study showed that the vaccine was safe to use at all doses tested, both with and without adjuvant. All participants who received the vaccine developed 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). Furthermore, those receiving the vaccine showed a meaningful increase in white blood cells inducing the secretion of interferon gamma and Interleukin-2. Thus, the vaccine activated both the humoral (antibody) and the innate (cellular) arms of the human immune system.

The Multimeric-001 Universal Vaccine is a single formulation consisting of nine conserved linear epitopes in triplicate. The epitopes selected were taken from hemagglutinin (HA), nucleoprotein (NP), and matrix (M) proteins, therefore ensuring high antigen content. These epitopes are common to practically all existing and future flu virus strains, including both seasonal and pandemic flu strains such as the avian and swine flu, regardless of their antigenic drift and shifts.

This trial was 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, said, "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 as required by current existing vaccines."

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