Table 1.

Primary Endpoint for Shigellosis in Shigella Controlled Human Infection Model

Primary Endpoint (Shigellosis)	Definition
1. Severe diarrhea	≥6 loose stoolsa in 24 h OR >800 g loose stools in 24 h
2. Moderate diarrhea	[4–5 loose stools in 24 h OR 400–800 g loose stools in 24 h] AND [oral temperature ≥38.0°Cb OR ≥1 moderate constitutional/ enteric symptomc OR ≥2 episodes of vomiting in 24 h]
3. Dysentery	≥2 loose stools with gross blood (hemoccult positive) in 24 h AND [oral temperature ≥38.0°C OR ≥1 moderate constitutional/ enteric symptom OR ≥2 episodes of vomiting in 24 h]

Participant must fulfill any 1 of the 3 possible endpoint scenarios to qualify as having reached the primary endpoint of shigellosis.

^aGrade 3 to 5.

^bConfirmed by 2 separate readings at least 5 minutes apart.

^cSee Table 2.