The trial met a key endpoint, demonstrating a clinically relevant adjuvant effect when the Iomai patch was used with a single dose of the 45-microgram H5N1 vaccine. The trial found that a single 45-microgram dose of an H5N1 influenza vaccine, coupled with a single 50-microgram Iomai patch, was sufficient to provide an immune response considered protective in 73% of those tested a statistically significant improvement over those who received the H5N1 influenza vaccine alone.
This is claimed to be one of the first trials to demonstrate that a single dose of pandemic influenza vaccine may meet the level of protection suggested in FDA guidance, which recommends that a pandemic vaccine achieve immune response levels considered protective in 70% or more of vaccine recipients.
Gregory Glenn, Iomai’s chief scientific officer, said: “This data also confirms our general approach of using an adjuvant patch to improve the immune response to injected vaccines and the ability of our adjuvant to safely and effectively stimulate robust immune responses via the skin. We continue to explore ways to bring this approach to other applications in the high-value field of vaccine adjuvants.”