A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area

Exclusion criteria

• . Women who are pregnant or lactating or have a positive urine pregnancy test at screening or on the day of vaccinations.
• . Presence or history of a chronic medical condition\* that would, in the opinion of the investigator, render vaccination unsafe or interfere with the evaluation of the vaccine.
• . Presence of a significant dermatologic condition\*, or tattoo(s), scarring or significant skin damage at the vaccination site that would impede evaluation of local reactogenicity.
• . Any developmental abnormality of the palate.
• . Participants diagnosed with autoimmune disorders, chronic inflammatory disorders or neurological disorders with a potential autoimmune correlation.
• . Use of long-term (\> / = 2 weeks) oral steroids, intranasal or topical prednisone (or equivalent), parenteral steroids, or high-dose inhaled steroids (\> 800 microgram/day of beclomethasone dipropionate or equivalent) within the preceding 6 months.
• . Has major psychiatric illness\* during last 12 months that in the investigator's opinion would preclude participation.
• . Use of prescription or over-the-counter (OTC) anti-inflammatory medications\* 48 hours prior to receiving the investigational product.