September 6, 2007 - Iomai Corp. said it began dosing in a Phase 1/2 study to assess the safety and dose-sparing capability of the company's immunostimulant patch when used in combination with an injected H5N1 influenza vaccine.
The Iomai patch, which contains a powerful immune-stimulating adjuvant, is used in conjunction with an injected influenza vaccine and may generate an immune response with small amounts of vaccine antigen. If successful, Iomai's approach may expand the pandemic influenza vaccine supply in the event of an influenza pandemic. This clinical trial is funded through an advanced development contract from the U.S. Department of Health and Human Services.
The study will enroll as many as 500 subjects, who will receive either a placebo injection or one of three dosages of pandemic influenza vaccine. Patients will receive a booster shot of placebo or vaccine 21 days later. Of these patients, approximately one-third will receive no immunostimulant patch, one-third will receive a patch only with the booster shot, and one-third will receive a patch with both vaccine injections. Subjects will be followed for safety, and immune responses to the pandemic vaccine will be evaluated.
Existing pandemic influenza vaccine manufacturing capacity is limited, and research suggests the amount of vaccine antigen required to generate a protective effect is far higher than the amount of vaccine needed for protection from seasonal influenza. While development of adjuvants - compounds that increase the body's immune response to vaccines - has accelerated in recent years, existing efforts have focused on combining adjuvant with antigen in a single shot. Iomai is unique in developing a patch- based adjuvant that may be used with any manufacturer's vaccine.
Iomai Corporation develops vaccines and immune system stimulants delivered via needle-free technology called transcutaneous immunization (TCI). TCI taps into the unique benefits of a major group of antigen-presenting cells found in the outer layers of the skin (Langerhans cells) to generate an enhanced immune response. Iomai is leveraging TCI to enhance the efficacy of existing vaccines, develop new vaccines that are viable only through transcutaneous administration and expand the global vaccine market. Iomai currently has four product candidates in development: three targeting influenza and pandemic flu and one to prevent travelers' diarrhea.
For more information: www.iomai.com