Participants Needed for Shigella Vaccine Research Study
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. Cohorts 1-3 have been completed and enrollment is open for Cohort 4.
The fourth cohort will be an adaptive design consisting of 30 study participants to be randomly allocated to receive either two doses of vaccine, one dose of vaccine, or two doses of placebo. This fourth cohort involves a screening, two vaccination visits and six follow-up visits over the course of six to eight months.
QUALIFIED PARTICIPANTS MUST
QUALIFIED PARTICIPANTS WILL RECEIVE