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Vical H1 Influenza Vaccine Delivers Robust Preclinical Results With 100% Response
Jun 30, 2009 6:30:00 AM
2009 GlobeNewswire, Inc.



View Additional ProfilesSAN DIEGO, June 30, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today that the company's vaccine against A/H1N1 pandemic influenza (swine flu) produced robust immune responses well above the accepted protection threshold in 100% of vaccinated mice and rabbits after a standard two-dose vaccine regimen. In addition, at least 75% of vaccinated animals achieved or exceeded the protection threshold after a single dose of vaccine. The company is ready to advance directly to large-scale cGMP manufacturing of the vaccine for human clinical trials, subject to securing external funding for this program.

"Our DNA vaccine technology offers an innovative approach to dealing with pandemics," said Vijay B. Samant, President and Chief Executive Officer of Vical. "The speed of our platform both in development and manufacturing was demonstrated by our rapid completion of vaccine production and successful immunogenicity testing in animals while conventional vaccine manufacturers are still working toward production of their initial supply of H1 vaccine. We are encouraged by these compelling data with our Vaxfectin(r)-formulated DNA vaccine and we look forward to advancing to human clinical trials as soon as possible."

Vical's plasmid DNA vaccine contained the H1 hemagglutinin gene sequence provided by the U.S. Centers for Disease Control and Prevention (CDC) for the A/H1N1 influenza strain selected on April 30. The preclinical vaccine was produced by May 11 and animal testing began on May 15. In two parallel animal studies, one in mice and one in rabbits, vaccine was administered on Day 0 and Day 21, a standard regimen for pandemic influenza vaccines. Sera collected on Day 21, after a single dose of vaccine, showed clear increases over baseline hemagglutination inhibition (HI) titers in 100% of the animals, and HI titers above the protection threshold in 88% of the mice and 75% of the rabbits. Sera collected on Day 35, two weeks after the second dose, showed HI titers well above the protection threshold in 100% of the animals, ranging from 320 to 2,560 (geometric mean titer = 987) in the mice, and from 640 to 2,560 (geometric mean titer = 1,522) in the rabbits. The HI assay measures a vaccine's ability to prevent viruses from binding to cells, and HI titers of 40 or more are accepted as the threshold for potential protection against influenza viruses. The vaccine encoded H1 hemagglutinin from the swine-origin A/California/04/09 wild-type influenza virus. Vical ran the HI assay against the swine-origin A/California/07/09 x-179a reassortant influenza virus obtained from the CDC.