Controlled Human Infection Model Challenge/Rechallenge

Inclusion criteria

• . Healthy adults, male or female, aged 18 to 50 years (all inclusive) at the time of enrollment.
• . General good health, without clinically significant medical history, physical examination findings, or clinical laboratory abnormalities per judgment of Principal Investigator (PI).
• . Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.
• . Completion of a training session and demonstrated comprehension of the protocol procedures and knowledge of Shigella-associated illness by passing a written examination (70% passing score).
• . Availability for the study duration, including all planned follow-up visits.
• . Female participants must have a negative pregnancy test at screening and prior to each challenge.
• . Female participants must agree to avoid pregnancy for 29 days following the last challenge dose by use of an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. Female participants unable to bear children must have this documented (e.g., tubal ligation or hysterectomy).
• . Willingness to refrain from participation in a study of another investigational agent for 90 days following the last challenge dose.

Exclusion criteria