Table 3. Immune cells in ectocervical tissue at the end of treatment (visit 31) based on treatment and dosing assignment.
TFVLNG continuous | TFVLNG Interrupted | Placebo Continuous | Placebo Interrupted | P | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
N | Median | IQR 25 | IQR 75 | N | Median | IQR 25 | IQR 75 | N | Median | IQR 25 | IQR 75 | N | Median | IQR 25 | IQR 75 | ||
Histology | |||||||||||||||||
Epithelial Thickness (μm) | 13 | 240 | 206.7 | 268 | 15 | 298 | 223.3 | 378.3 | 5 | 236.7 | 180 | 306.7 | 4 | 258.5 | 191.8 | 372.5 | 0.32 |
Number Cell Layers | 13 | 17.4 | 16.3 | 19.5 | 15 | 21.7 | 19.7 | 23.3 | 5 | 16.2 | 13.3 | 20.5 | 4 | 17.3 | 14.1 | 24.2 | 0.23 |
Cells in the Ectocervical Epithelium (cells/mm2) | |||||||||||||||||
CD45 | 13 | 107.9 | 90.2 | 119.7 | 15 | 67.3 | 54.3 | 115.3 | 5 | 116.2 | 67.6 | 148.5 | 4 | 101.9 | 65.1 | 143.3 | 0.36 |
CD3 | 13 | 67.9 | 57.3 | 80.2 | 15 | 47.9 | 33.3 | 77.3 | 5 | 80.8 | 47.4 | 122.9 | 4 | 69.9 | 49.3 | 90.5 | 0.32 |
CD8 | 13 | 43.6 | 36.7 | 61.7 | 15 | 30.4 | 10.7 | 58.5 | 5 | 47.1 | 32 | 84.5 | 4 | 40.6 | 27.2 | 59 | 0.27 |
HLADR | 13 | 36.7 | 30.3 | 46.2 | 15 | 36.5 | 30.8 | 50.2 | 5 | 65.7 | 20.5 | 78.7 | 4 | 30.7 | 25.7 | 50.3 | 0.82 |
Cells in the Ectocervical Lamina Propria (cells/mm2) | |||||||||||||||||
CD45 | 13 | 72 | 64 | 148 | 13 | 86.4 | 52 | 144 | 5 | 93.3 | 72 | 112 | 4 | 94 | 70 | 169.6 | 0.96 |
CD3 | 13 | 38.4 | 36 | 106.7 | 13 | 48 | 32 | 82.7 | 5 | 56 | 38.4 | 80 | 4 | 49.3 | 36 | 108.5 | 0.97 |
CD8 | 13 | 22.4 | 16 | 52 | 13 | 24 | 12 | 48 | 5 | 26.7 | 22.4 | 44.8 | 4 | 28 | 20 | 60.8 | 0.92 |
HLADR | 13 | 42.7 | 28 | 48 | 13 | 48 | 40 | 64 | 5 | 44.8 | 32 | 50.7 | 4 | 43.3 | 32 | 44.7 | 0.62 |
IQR = Interquartile range
* p values determined using Kruskall Wallis test.