“Bacterial diarrheal disease is a significant medical problem both for children and travelers,” said Gregory Glenn, M.D., chief scientific officer of the Iomai Corporation that is engaged in the study.
“We look forward to targeting both the significant travelers’ market and developing the vaccine for the children in the developing world who still suffer serious morbidity and mortality from this disease.”
The study, which followed 170 healthy travelers ages 18-64 to Mexico and Guatemala, found that of the 59 individuals who received the novel vaccine, only three suffered from moderate or severe diarrhea, while roughly two dozen of the 111 who received a placebo suffered from moderate or severe diarrhea. Only one of the 59 volunteers in the vaccine group reported severe diarrhea, compared with 12 in the placebo group.
Each volunteer received either two doses of the vaccine patch or a placebo, 2 to 3 weeks apart, with the last dose administered a week before travel. Travelers kept detailed diaries and received in-country checkups. The study was designed to evaluate the safety of the vaccine and the incidence of enterotoxigenic E. coli (ETEC) bacteria – the most common cause of travelers’ diarrhea. No vaccine-related serious side effects were reported.
Of the vaccinated patients who became sick, the diarrhea lasted only half a day on average, while those in the placebo group endured two days of illness and more than twice as many loose stools. The initiation of a Phase 3 programme for the needle-free patch vaccine is planned for 2009.
MEDICA.de; Source: University of Texas