Table 4.
|
Cohort 1 |
Cohort 2 |
Cohorts 3 and 4 |
Cohort 5 |
Cohort 6 |
Cohort 7 |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Day | 107 µg FimCH | 50 µg FimCH 10 µg adjuvant |
50 µg FimCH 20 µg adjuvant |
50 µg FimCH 40 µg adjuvant |
50 µg FimCH 40 µg adjuvant |
107 µg FimCH 43 µg adjuvant |
||||||||||||
N | GMT | 95% CI | N | GMT | 95% CI | N | GMT | 95% CI | N | GMT | 95% CI | N | GMT | 95% CI | N | GMT | 95% CI | |
1 | 5 | - | - | 8 | - | - | 16 | - | - | 8 | - | - | 16 | - | - | 14 | 4 | 3–6 |
30 | 5 | 10 | 1,76 | 8 | 14 | 4,47 | 16 | 8 | 4,19 | 7 | 20 | 4,93 | 15 | 20 | 6,65 | 14 | 15 | 7,33 |
60 | 4 | 65 | 6,764 | 8 | 63 | 16,240 | 13 | 124 | 47,329 | 7 | 456 | 139,1498 | 15 | 125 | 48,323 | 14 | 155 | 53,453 |
90 | 4 | 32 | 3,400 | 8 | 40 | 13,124 | 14 | 61 | 27,137 | 7 | 223 | 62,804 | 14 | 82 | 34,197 | 13 | 89 | 29,278 |
120 | 4 | 149 | 2,9253 | 7 | 125 | 26,607 | 14 | 435 | 180,1051 | 7 | 426 | 121,1505 | 14 | 389 | 228,662 | 13 | 322 | 153,678 |
180 | 3 | 22 | 5,97 | 7 | 51 | 13,202 | 14 | 95 | 46,197 | 7 | 188 | 36,991 | 13 | 141 | 72,275 | 13 | 105 | 39,280 |
210 | 3 | 235 | 9,5872 | 7 | 215 | 71,651 | 14 | 427 | 175,1043 | 7 | 1024 | 263,3993 | 13 | 473 | 247,904 | 13 | 706 | 294,1691 |
360 | 3 | 22 | 6,82 | 7 | 23 | 6,84 | 14 | 49 | 24,102 | 6 | 154 | 47,507 | 13 | 57 | 28,116 | 13 | 61 | 24,154 |
GMT – geometric mean titer; fold increase calculated using ½ the limit of quantitation of 3 µg/ml.