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Biosecurity News in Brief
H5N1 Vaccine Adjuvant Patch Enters Phase II TrialsBy Kunal Rambhia, April 18, 2008 On April 15, 2008, Reuters reported that Iomai, a small biotechnology company located in Gaithersburg, MD, received “U.S. [Department of Health and Human Services] approval…” to begin phase II clinical trials testing “a bird flu skin patch on more people.”1 The patch contains an immunological enhancing agent, or adjuvant, meant for use in conjunction with a vaccine to increase the vaccine’s effectiveness. Last year, HHS awarded $128 million to Iomai to develop the patch. Phase II trials will test the safety and efficacy of the product in a few dozen people. Traditionally, adjuvants are mixed in with a vaccine. However, HHS believes that the adjuvant patch may be a more effective method of delivery. According to Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), the adjuvant is absorbed into the skin where cells just beneath skin level “take up the adjuvant and go directly to the lymph nodes.”1 Preliminary studies show that the patch enhances an H5N1 vaccine so that only one dose is required to achieve protection. Without the patch adjuvant, the current H5N1 vaccine requires two doses. The article notes that “global flu vaccine production capabilities are limited and if larger doses are needed, fewer people could be vaccinated in a pandemic.” The adjuvant patch may “help stretch the vaccine supply during a pandemic.”1 In related news, on April 8, Iomai issued a press release announcing its award of a U.S. Army Medical Research and Materiel Command (USAMRMC) “cost reimbursement grant” of up to $943,856 to do “preclinical work on a patch-based version of the anthrax vaccine.”2 Iomai scientists plan to use vaccine antigen “developed by UK-based Avecia Biologics Ltd,” and apply Avecia’s adjuvant technologies in the creation of a “needle-free” anthrax vaccine patch.2 The anthrax vaccine currently licensed for use in the U.S. requires 6 shots administered over an 18 month period, and it must be stored in a refrigerator. Iomai hopes to create a vaccine that can be “stockpiled and shipped at room temperature,”2 and may limit the amount of antigen required for protection. References
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