Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 1 Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) From Enterotoxigenic Escherichia Coli (ET
Brief Summary: Many infectious pathogens, like ETEC, initiate infection by first interacting with the gut mucosal surfaces of their human host. Consequently, vaccination strategies that can better stimulate protective mucosal immunity are needed if we are to effectively control the large number of intestinal pathogens that cause morbidity and mortality in humans. The LT toxin of ETEC is a unique antigen in that it also has inherent mucosal adjuvant properties for co-administered antigens. Thus, this protein has the potential to be both a stand-alone vaccine as well as a mucosal adjuvant for other co-administered vaccine antigens. The primary objective is to assess the safety and tolerability of dmLT vaccine when administered in three doses intradermally over a range of dosages in healthy adult subjects.