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Intercell is developing a Pandemic Influenza patch that is designed to enhance the immune response to existing injected Pandemic Influenza vaccines. If successful, the patch will expand the limited vaccine supplies by allowing fewer or lower doses of vaccine. The program is funded by a United States Department of Health and Human Services contract.

A novel needle-free vaccine patch

After a dose of injected vaccine is given, the patch is placed over the vaccination site. The adjuvant is then carried by immune cells in the skin to the lymph nodes where the adjuvant augments the immune response to the injected vaccine.

The vaccine enhancement patch has generated positive data in ongoing trials when used in conjunction with an injected pandemic influenza candidate. Key results from Phase I/II clinical trial found that a single 45-microgram dose of an H5N1 influenza vaccine, coupled with a single 50-microgram Intercell patch, was sufficient to provide an immune response considered protective in 73 percent of those tested, which was a statistically significant improvement over those who received the H5N1 influenza vaccine alone. The trial is one of the first to demonstrate that a single dose of pandemic influenza vaccine may meet the level of protection suggested in guidelines by U.S. Food and Drug Administration and the European Medicines Agency (70 percent seroprotection).

Phase II clinical trail comprising 500 subjects was started in May 28, 2009. The program is fully funded by the United States Department of Health and Human Services. For the development and commercialization Intercell has an strategic alliance with GSK.

The steady threat of Influenza Pandemics

During the 20th century, several major pandemics occurred, including the 1919 Spanish Influenza that killed as many as 40 million people . The threat of a new global pandemic Influenza, such as the recent outbreak of the avian influenza strain H5N1, or bird, Influenza, underscores the need for efficient vaccines that can be quickly and easy administered.

Current prevention

At present, the only approved pandemic vaccine has a suboptimal profile, requiring high antigen doses given over the course of two doses. Other vaccines in development use smaller doses of vaccine but still require two injections, given days apart. Our innovative delivery technology of a needle-free vaccine patch expands the possibility of a novel efficient vaccine which require lower or fewer doses and thereby expands limited vaccine stocks.

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• GSK
• United States Department of Health and Human Services (HHS)

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