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Vical Announces Breakthrough for Pandemic Influenza DNA Vaccines With Preliminary Human Data
Date:7/16/2008

H5 DNA doses, and there were no responders in the placebo cohort. More than 90% of the responders had sustained HI titers through the last measurement to date (Day 84). Neutralizing antibody production against H5 was demonstrated separately by microneutralization assays. For comparison, the protein-based pandemic influenza vaccine currently stockpiled by the U.S. government was approved with HI titers of 40 or more in 44% of subjects by Day 56.

Even at the lowest dose tested (0.033 mg H5 DNA), one of the six subjects was a responder by Day 56. Some subjects who received the highest H5 DNA dose were responders at Day 21 after a single vaccine injection. Preliminary analyses also showed cross-strain immune responses against a strain of H5N1 from a clade not matching the vaccine. Cross-strain protection could be important against emerging strains of pandemic influenza that may not match vaccine stockpiles.

Additional assays are ongoing to further evaluate antibody responses, breadth and magnitude of T-cell immune responses, cross-strain responses, and the relative advantages of monovalent vs. trivalent vaccines and needle vs. needle-free injection.

"These results are important to Vical for three reasons," added Mr. Samant. "First, they encourage further development of pandemic influenza DNA vaccines, for which we are currently exploring funding or partnering options. Second, they support advancement of additional Vaxfectin(R)-formulated DNA vaccines toward clinical testing. Third, they provide new incentives for potential commercial partners and collaborators to explore additional applications for our Vaxfectin(R) adjuvant for DNA vaccines as well as protein and peptide-based vaccines. We are excited by these strong preliminary antibody results, and we look forward to evaluating more detailed immunogenicity data as they become available."

DNA vaccines may offer both technical and economic advantages compared with conventional vaccine approac
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SOURCE Vical Incorporated
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