Diarrheal disease is a significant cause of morbidity and mortality worldwide; it is the second leading cause of death in children under the age of 5, with approximately 800,000 deaths annually. Both Shigella and ETEC are common causes of traveler’s diarrhea and global children’s diarrhea.
This research is a phase 1, double-blind, placebo-controlled, dose-escalating, single-center study, involving three vaccine dosage escalation cohorts (108, 109, and 1010 cfu vaccine organisms) evaluating a combined Shigella and ETEC vaccine.
Each of the three dose-escalation cohorts will consist of 8 study participants who will be randomly allocated to receive either vaccine or placebo, as a single, oral dose.
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