Iomai launches study of vaccine patch for travelers' diarrhea

Iomai Corporation has announced that it has begun enrollment of a Phase 2 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 3 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 and offer other details that will be key for the coming Phase 3 trial. Most cases of travelers' diarrhea are caused by ETEC, and as many as 50 percent of travelers to areas where the bacteria is endemic are sickened over a one- to two-week period. No ETEC vaccine is available in the United States.

"The Phase 2 field test sets the groundwork for our pivotal trial of the travelers' diarrhea vaccine, which may offer advanced, needle-free protection from a common bacterial infection," said Stanley C. Erck, President and Chief Executive Officer of Iomai. "This study is part of a comprehensive Phase 2 development program also designed to assess the ideal dose and formulation of the patch, as well as gather data on how the vaccine patch can be applied."

Participants in the field study must be traveling to sites in and around Cuernavaca or Guadalajara, Mexico or Antigua, Guatemala. For more information on how to volunteer for the field study, please visit www.trekstudy.com.

Based on Iomai's novel transcutaneous immunization (TCI) 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.