A Human Challenge Study to Assess Protection of a Shigella Tetravalent Bioconjugate Vaccine

Inclusion criteria

• . Age 18-50 years (inclusive).
• . In good health and stable medical condition, determined by MH, laboratory results, and physical examination during screening period.
• . Negative pregnancy test at the time of 1st injection, for participants of childbearing potential.
• . Persons of childbearing potential must agree to avoid pregnancy by use of effective contraception for 30 days prior to 1st injection and throughout the study. Participants assigned female at birth and unable to bear children must have this documented (e.g., tubal ligation or hysterectomy).
• . Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.
• . Availability for the study duration, including all planned follow-up visits and phone calls.
• . Willingness to refrain from participating in other studies of investigational products until completion of the last study contact.
• . Demonstrated comprehension of the protocol procedures, knowledge of Shigella- associated illness, and passing score of 70% or better on a comprehension assessment. Maximum two attempts are allowed.

Exclusion criteria