Universal Influenza Vaccine Passes Clinical Trial in Elderly Population

Development of a Universal Influenza Vaccine advanced another step with the successful completion of the clinical phase of its second Phase I/II clinical trial.

The Multimeric-001 Universal Flu Vaccine, under development by BiondVax Pharmaceuticals (Rehovot, Israel), was tested in a randomized, single-blind, placebo-controlled, escalating double-dose safety study on a total 60 participants aged 55-75, who received two injections, either with or without adjuvant, at two different doses and in accordance with the approved clinical trial design. This phase of the study was directed at an older population group, which is considered most at-risk for influenza infections.

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 second of two Phase I/II clinical trials of the Multimeric-001.

Dr. Ron Babecoff, CEO of BiondVax, said, "These latest excellent safety results are further evidence of the positive safety profile of our Multimeric-001 vaccine. We are especially pleased to have been able to show the safety of the vaccine in the elderly population, which is one of the most at-risk and vulnerable sectors of the population to flu infections. Following the recent success of the first Phase I/II study in which we showed proof of the safety and immunogenicity of our vaccine in younger participants, these additional safety results represent yet another successful achievement in our path towards the development of the Universal Flu Vaccine.”

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