FDAnews
www.fdanews.com/articles/61736-iomai-launches-study-of-e-coli-vaccine-patch

IOMAI LAUNCHES STUDY OF E. COLI VACCINE PATCH

August 15, 2006

Iomai has begun enrollment in a Phase II trial designed to test its vaccine patch for travelers' diarrhea in volunteers traveling to sites in Mexico and Guatemala. The field test will provide the investigators with the crucial information needed to launch a Phase III trial of the needle-free vaccine.

The placebo-controlled study is designed to assess the safety of the vaccine and the frequency of enterotoxigenic E. coli (ETEC) infection in volunteers traveling to sites where the disease is endemic. Most cases of travelers' diarrhea are caused by ETEC, and as many as 50 percent of travelers to areas where the disease is endemic are sickened for a one- to two-week period. No ETEC vaccine is yet available in the United States.

Based on Iomai's transcutaneous immunization technology, the patch works by delivering vaccine to a group of antigen-presenting cells in the skin called Langerhans cells, which transport the vaccine to nearby lymph nodes to produce a sustained immune response.