TABLE 5.

Clinical and bacteriologic responses to challenge with V. cholerae O1 El Tor Inaba strain N16961 after volunteers received Peru-15 vaccine or placebo

Parameter	Value for subjects given:		P valuea
	Vaccine	Placebo
Total no. of subjects	24	12
No. of subjects with moderate or severe diarrhea (≥3,000 g of diarrheal stool) (%)	0 (0)	5 (42)	0.002
No. of subjects with any diarrhea (%)	1 (4)	7 (58)	0.0006
Mean diarrheal stool wt (g) for all volunteers (range)	0.26 (0-2,197)	1,022 (0-12,593)	<0.0001
Mean diarrheal stool wt (g) for all volunteers with diarrhea (range)	2,197	4,504 (10-12,593)	0.88
Mean no. of diarrheal stools for all volunteers (range)	0.5 (0-13)	15 (0-43)	<0.0001
Mean no. of diarrheal stools for all volunteers with diarrhea (range)	13	18 (1-43)	0.88
Incidence of fever (%)	2 (8)	6 (50)	0.009
Stool V. cholerae O1 excretion (%)	13 (54)	10 (83)	0.09
Mean peak stool V. cholerae O1 excretion for all volunteers (CFU/g) (range)	2.1 × 102 (0-1.2 × 108)	3.9 × 106 (0-7.8 × 108)	0.003

^aP values comparing the values for subjects given vaccine to those for subjects given placebo.