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BiondVax Begins Phase IIa Study for Universal Flu Vaccine
Date:10/11/2010

afety and immunogenicity of the Multimeric-001 firstly as a standalone vaccine, secondly as a primer for a subsequent partial dose of a commercially available trivalent inactivated vaccine (TIV), and lastly when the Multimeric-001 vaccine is co-administered together with a TIV.

Participants in the first group will receive two 500 microgram doses of an adjuvanted formulation of the Multimeric-001 vaccine (the formulation that performed best in the previous Phase I/II trials), 21 days apart.  These participants will then receive a subsequent partial (15%) dose of a TIV, 60 days after their second immunization.  Participants in this treatment group will be compared against two control groups: one group that will receive two administrations of placebo 21 days apart, also followed 60 days later by a partial (15%) dose of TIV, and another group that will only receive two administrations of adjuvanted placebo, 21 days apart.  

Participants in the fourth and fifth groups will receive a single 500 microgram dose of the adjuvanted formulation of the Multimeric-001 vaccine, co-administered with either a 15% or 50% dose of the TIV, respectively.  These groups will be compared against a control group that will receive a placebo formulation co-administered with the higher of the two TIV doses.

The primary objectives of the Phase IIa study are to assess safety and immunogenicity, as measured by the level of IgG antibodies to the Multimeric-001 vaccine.  The secondary objectives of the study are to measure additional antibody and cellular immune responses, in particular neutralization by complement, Hemagglutination inhibition (HI) responses (a measure of protection) against various strains of influenza, as well as proliferation of Interleukin-2 (IL-2) and Interferon-gamma cytokines.  The company expects to report study results by mid-2011.For further information, please contact:Danny Aronovic
Public Relations Consultant
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SOURCE BiondVax Pharmaceuticals Ltd.
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