TABLE 3.
Clinical and bacteriologic responses to challenge with V. cholerae O1 El Tor Inaba strain N16961 after receipt of CVD 103-HgR vaccine or placebo
| Parameter | Vaccinees
|
Placebo
recipients
|
P | ||||
|---|---|---|---|---|---|---|---|
| Total | Blood group O | Blood group non-O | Total | Blood group O | Blood group non-O | ||
| n (%) | 28 | 15 (54) | 13 (46) | 23 | 8 (35) | 15 (65) | 0.26a |
| Moderate or severe cholera (≥3-liter diarrheal stool) (%) | 1 (4) | 1 (7) | 0 (0) | 9 (39) | 4 (50) | 5 (33) | 0.003b |
| Any diarrhea (%) | 5 (18) | 4 (27) | 1 (8) | 21 (91) | 7 (88) | 14 (93) | <0.001b |
| Mean diarrheal stool volume in liters for ill volunteers (range) | 2.0 (0.7–6.8) | 2.3 (0.7–6.8) | 0.7 | 3.5 (0.3–8.2) | 4.1 (0.5–7.1) | 3.2 (0.3–8.2) | 0.11b |
| No. of diarrheal stools for ill volunteers (range) | 13 (6–42) | 15 (6–42) | 6 | 23 (2–63) | 28 (4–63) | 20 (2–55) | 0.14b |
| Incidence of fever (%) | 0 | 0 | 0 | 6 (35) | 0 | 6 | 0.006b |
| Stool V. cholerae O1 excretion (%) | 17 (61) | 11 (73) | 6 (46) | 22 (96) | 7 (88) | 6 (40) | 0.003b |
| Mean peak stool V. cholerae O1 excretion for all volunteers (CFU/g) | 4.9 × 102 | 1.7 × 103 | 1.2 × 102 | 1.1 × 107 | 6.0 × 106 | 1.4 × 107 | <0.001b |
a
P value comparing proportion of volunteers of blood group O among vaccinees and placebo recipients.
b
P value comparing all vaccinees and all placebo recipients.