Table 2.
Protocol | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
61-07 | 62-01 | 63-06 | 64-06 | 64-12 | 64-14 | 64-15 | 65-05 | 65-13 | 66-01 | 66-13 | 67-01 | 68-04A | Overall | |||||
Target exposure (cfu) | 200 | 200 | 700 | 2,500 | 25,000 | 25,000 | 25,000 | 2,500 | 25,000 | 25,000 | 2,500 | 25,000 | 25,000 | 25,000 | 25,000 | 2,500 | 25,000 | |
Number of subjects with a fevera | 4 | 2 | 4 | 4 | 4 | 6 | 16 | 7 | 8 | 16 | 3 | 3 | 8 | 14 | 8 | 2 | 2 | 111 |
Mean time to fever (hour) | 159.0 | 198.0 | 162.0 | 85.5 | 79.5 | 68.1 | 85.5 | 114.4 | 81.8 | 77.6 | 109.0 | 58.0 | 56.3 | 68.6 | 85.5 | 107.0 | 81.0 | 88.1 |
SD | 38.88 | 140.01 | 76.76 | 19.21 | 10.25 | 9.53 | 33.33 | 38.71 | 16.80 | 12.58 | 34.12 | 1.73 | 5.26 | 21.24 | 12.73 | 0.00 | 2.83 | 40.17 |
Median time to fever (hour) | 162 | 198 | 135 | 93 | 78 | 66 | 81 | 99 | 81 | 75 | 99 | 57 | 57 | 72 | 81 | 107 | 81 | 81 |
Min | 111 | 99 | 105 | 57 | 69 | 57 | 27 | 93 | 63 | 57 | 81 | 57 | 45 | 3 | 75 | 107 | 79 | 3 |
Max | 201 | 297 | 273 | 99 | 93 | 81 | 171 | 201 | 105 | 105 | 147 | 60 | 63 | 87 | 105 | 107 | 83 | 297 |
Time to fever was determined for each subject (as defined in section Data Collection and Analysis) using the first time point of two consecutive temperatures of 100°F or greater and assumes a 9 a.m. challenge time on Day 0. Subjects who did not present with a fever are not included in these statistics. 6 subjects didn't have fever.