Table 4:
Percent with response in antibody secreting cell or antibodies in lymphocyte supernatants at select time points
| IgA | IgG | |||||||
|---|---|---|---|---|---|---|---|---|
| Dose | Day 8 | Day 22 | Day 36 | Any Time | Day 8 | Day 22 | Day 36 | Any Time |
| ASC | ||||||||
| Cohort 3 – 25 μg | 0 (0, 31) | 10 (0, 45) | 33 (7, 70) | 27 (6, 61) | 0 (0, 31) | 0 (0, 31) | 33 (7, 70) | 27 (6, 61) |
| Cohort 4 – 50 μg | 0 (0, 28) | 0 (0, 31) | 0 (0, 37) | 9 (0, 41) | 0 (0, 28) | 0 (0, 31) | 0 (0, 37) | 9 (0, 41) |
| Cohort 5 – 25 μg (Sublingual) | 0 (0, 21) | 0 (0, 22) | 0 (0, 22) | 0 (0, 21) | 0 (0, 21) | 0 (0, 22) | 0 (0, 22) | 0 (0, 21) |
| Cohort 5 – 25 μg (Oral) | 7 (0, 32) | 15 (2, 45) | 33 (10, 65) | 27 (8, 55) | 13 (2, 40) | 15 (2, 45) | 0 (0, 26) | 13 (2, 40) |
| ALS | ||||||||
| Cohort 3 – 25 μg | 0 (0, 31) | 30 (7, 65) | 33 (7, 70) | 27 (6, 61) | 20 (3, 56) | 30 (7, 65) | 44 (14, 79) | 36 (11, 69) |
| Cohort 4 – 50 μg | 0 (0, 28) | 20 (3, 56) | 13 (0, 53) | 18 (2, 52) | 9 (0, 41) | 20 (3, 56) | 25 (3, 65) | 27 (6, 61) |
| Cohort 5 – 25 μg (Sublingual) | 0 (0, 21) | 0 (0, 22) | 7 (0, 32) | 6 (0, 30) | 0 (0, 21) | 7 (0, 32) | 13 (2, 40) | 13 (2, 38) |
| Cohort 5 – 25 μg (Oral) | 7 (0, 32) | 15 (2, 45) | 17 (2, 48) | 40 (16, 68) | 13 (2, 40) | 15 (2, 45) | 17 (2, 48) | 27 (8, 55) |
Note: A responder is defined as >8 ASC / 106 PBMC for ASC, or having at least a 2-fold rise in antibody compared to pre-dose 1 for ALS. 95% CIs are shown in parenthesis
Only data for the higher doses at one week post each immunization are shown. Responses were minimal at the lower doses.