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Skin Patch Vaccine Reduces Risk of Travelers' Diarrhea: Presented at ICAAC By Charlene Laino CHICAGO, IL -- September 20, 2007 -- Transcutaneous immunization with the heat labile toxin of enterotoxigenic Escherichia coli (ETEC) protects against travelers' diarrhea, a phase 2 study shows. Herbert DuPont, MD, Director, Center for Infectious Diseases, University of Texas School of Public Health, Houston, Texas, presented the study here on September 18th at the 47th Annual International Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Seventeen million travelers are infected with ETEC each year, typically suffering bouts of vomiting and diarrhea that last about 3 to 5 days, said Gregory Glenn, MD, Chief Scientific Officer, Iomai Corporation, Gaithersburg, Maryland, the company that is developing the patch vaccine. The illness also raises the risk of developing irritable bowel syndrome by 10% to 30%, Dr Glenn said. In their study, Dr. DuPont and colleagues followed 170 travelers to Mexico and Guatemala. Each subject received either two doses of the vaccine patch or a placebo, 2 to 3 weeks apart, with the last dose administered a minimum of 7 days before travel. Travelers tracked stool output on diary cards and submitted samples for pathogen identification if diarrhea occurred. Results showed that three of 59 people who used the vaccine had moderate or severe diarrhea, defined as four or more stools in 24 hours, compared with 23 of the 111 who received a placebo. This translates to a 75% reduction in risk with the patch vaccine (P =.007). One of the 59 volunteers in the vaccine group reported severe diarrhea, defined as six or more stools in 24 hours, compared with 12 of the 111 in the placebo group. This translated to an 84% reduction in risk (P =.033). The mean number of loose stools was 3.7 in the vaccine group and 10.5 in the placebo group (P <.01). The mean days of diarrhea were 0.45 in the vaccine arm and 2.1 in the placebo arm (P <.01). Although not statistically significant, the frequency of new-onset irritable bowel syndrome was three times greater in placebo than vaccine recipients. No serious vaccine-related adverse events were reported. Funding for this study was provided by Iomai. The company plans to begin a phase 3 study of the vaccine patch in 2008. [Presentation title: Transcutaneous Immunization With the Heat Labile Toxin (LT) of Enterotoxigenic Escherichia Coli (ETEC) Protects in a Phase 2 Field Trial in Travelers to Guatemala (GU) and Mexico (MX). G-1247a] E-mail this page to a friend or colleague! To print, use this version