Iomai Announces Results From Phase I Travelers’ Diarrhea Patch Vaccine Study

Iomai announced that interim results from a Phase I safety and immunogenicity trial of its patch-based vaccine for travelers’ diarrhea found that all subjects who received the vaccine — 19 elderly and 17 adult participants — mounted an immune response.

The trial was designed to compare the number of subjects 65 and older who developed antibodies to the vaccine’s active ingredient with the number of participants between the ages of 18 and 40 who developed antibodies, Iomai said.

According to the company, all subjects who received the Iomai patch mounted an immune response.
 
The study was conducted in Belfast, Ireland, and subjects received two patches 21 days apart that contained heat labile toxin, and were followed for 42 days, the company added.

No treatment-related serious adverse effects were reported, the company said.

Interim results from this new study suggest that the protective effect of Iomai’s travelers’ diarrhea vaccine may apply to all adults, the company said. It added that it will look to confirm this in its Phase III trials, which it intends to launch in 2008.