Table 3.
Total ELISpot (SFU/106 PBMC) | Total (N = 10) | Cohort 1 (N = 7) | Cohort 2 (N = 3) |
---|---|---|---|
Baseline mean (n) | 7.6 (6) | 8.6 (3) | 6.7 (3) |
SD | 4.4 | 6.0 | 2.9 |
Week 4 mean (n) | 25.8 (6) | 36.3 (4) | 5.0 (2) |
SD | 27.0 | 27.6 | 7.1 |
Mean increase from baseline (n) | 16.8 (5) | 26.4 (3) | 2.5 (2) |
SD increase from baseline | 24.9 | 29.8 | 3.5 |
Week 8 mean (n) | 54.2 (7) | 75.3 (5) | 1.3 (2) |
SD | 69.1 | 72.1 | 1.8 |
Mean increase from baseline (n) | 34.2 (4) | 68.3 (2) | 0.0 (2) |
SD increase from baseline | 48.7 | 49.5 | 0.0 |
Week 12 mean (n) | 298.5 (5) | 369.0 (4) | 16.7 (1) |
SD | 371.8 | 388.8 | NA |
Mean increase from baseline (n) | 266.7 (4) | 353.3 (3) | 6.7 (1) |
SD increase from baseline | 422.8 | 472.3 | NA |
Week 16 mean (n) | 199.4 (8) | 218.8 (7) | 63.3 (1) |
SD | 304.7 | 323.7 | NA |
Mean increase from baseline (n) | 246.0 (4) | 310.3 (3) | 53.3 (1) |
SD increase from baseline | 397.0 | 460.0 | NA |
Week 24 mean (n) | 171.7 (6) | 171.7 (6) | ND |
SD | 233.5 | 233.5 | |
Mean increase from baseline (n) | 244.2 (3) | 244.2 (3) | |
SD increase from baseline | 324.8 | 324.8 | |
Week 32 mean (n) | 94.3 (7) | 106.7 (6) | 20.0 (1) |
SD | 99.5 | 102.9 | NA |
Mean increase from baseline (n) | 94.0 (4) | 121.9 (3) | 10 (1) |
SD increase from baseline | 122.5 | 133.4 | NA |
Week 48 mean (n) | 180.6 (3) | 180.6 (3) | ND |
SD | 285.7 | 285.7 | |
Mean increase from baseline (n) | 248.8 (2) | 248.8 (2) | |
SD increase from baseline | 351.8 | 351.8 |
Abbreviations: CI = confidence interval; NA = not applicable; ND = not done; SD = standard deviation.
The (n) for mean increase from baseline at each time point represents only the patients who also had corresponding baseline samples available. Therefore, the number of patient samples analyzed at the indicated time point may differ from the number of patients in whom the mean increase from baseline could be assessed.