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Study Finds Single Dose of Iomai Patch With Pandemic Flu Vaccine Achieves Protective Levels
Date:3/20/2008

face two large hurdles. The first is the possibility of limited vaccine stocks. The second is the logistic difficulty of administering two vaccinations over a period of several weeks to all individuals in the face of a pandemic. This new research clearly indicates that a single dose of vaccine in combination with an Iomai patch could provide a significant level of protection, achieve protective levels more rapidly, and increase compliance," said Stanley C. Erck, President and Chief Executive Officer of Iomai. "This is a major breakthrough and could provide public health officials with an important solution for this looming problem."

The trial tested three different dose levels of Solvay Biologicals, B.V. (Netherlands) egg-derived H5N1 influenza vaccine, the adjuvant patch and placebo to determine which combinations would be most effective in a two-immunization regimen, administered 21 days apart. Data showed that 92 percent of the 50 subjects vaccinated a single time with the 45-microgram dose in combination with the Iomai patch had an immune response. Seventy-three percent of those subjects achieved an HI titer of greater than 40, which is considered protective, offering the potential to eliminate the need for a second vaccination. About 49 percent of those who received the vaccine alone, without a patch, had an immune response considered protective after the first dose, and the 24 percentage point difference between the patch and no-patch groups was statistically significant (p<0.0001). A second dose of both vaccine and patch further enhanced immunogenicity; 100 percent of subjects who received two 45-microgram doses of vaccine and two Iomai patches had a measurable immune response, and 94 percent of subjects had immune responses considered protective.

No treatment-related serious adverse events were reported.

With further testing, the patch has the potential to be used in conjunction with other injected pandemic influenza vaccines. It has be
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SOURCE Iomai Corporation
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