d on an earlier study in mice, presented last year, which suggested the potential for Vaxfectin(TM) to be used as a dose-sparing agent with conventional influenza vaccines. Both studies used the Fluzone(R) 2005-2006 Formula trivalent inactivated seasonal influenza vaccine. In the recent study, mice were vaccinated with 1, 3, or 9 mcg of Fluzone(R) alone, or Fluzone(R) formulated with one of two dose levels of Vaxfectin(TM). Immune responses were evaluated by measuring hemagglutination inhibition (HI) antibody titers, the accepted standard correlate of protection for conventional influenza vaccines, against a single influenza strain included in the trivalent inactivated vaccine, as well as total antibody titers against all three of the strains included in the vaccine. Vaxfectin(TM)-formulated vaccines yielded HI antibody titers up to 30-fold higher, and total antibody titers up to 60-fold higher than unformulated vaccines at the same dose. Vaccines formulated with even the lowest tested dose of Vaxfectin(TM) yielded equivalent or better immune responses at the 1 mcg dose than unformulated vaccines at the 9 mcg dose, confirming the dose-sparing potential of Vaxfectin(TM). The improved performance of Vaxfectin(TM) in the latest studies reflected further optimization of the Vaxfectin(TM)/vaccine ratio at each of three dosing levels tested in mice.

Vaxfectin(TM) was designed by Vical to increase the immune response to DNA vaccines, and Vaxfectin(TM)-formulated DNA vaccines have demonstrated good tolerability and adjuvant activity in multiple animal models, including nonhuman primates. The Fluzone(R) data suggest that Vaxfectin(TM) could provide a dose-sparing effect with the government-stockpiled H5N1 pandemic influenza vaccine, also produced by sanofi pasteur. Since neither Fluzone(R) nor the sanofi pasteur H5N1 pandemic influenza vaccine are formulated with an adjuvant, Vaxfectin(TM) could, if approved, simply be added to either vaccine prior to administration.
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