Table 3:
Serum Anti-dmLT IgA and IgG Seroconversion (4-fold rise)
| Cohorts, dmLT Doses and Routes | ||||||||
|---|---|---|---|---|---|---|---|---|
| Days post vaccination |
4-fold risea | 1 | 2 | 3 | 4 | 5, 25 μg | p value* | |
| 1 μg | 5 μg | 25 μg | 50 μg | Sublingual | Oral | |||
| Day 8 | n | 12 | 14 | 10 | 11 | 16 | 15 | |
| IgA | 0 (0, 26)b | 0 (0, 23) | 0 (0, 31) | 0 (0, 28) | 0 (0, 21) | 7 (0, 32) | 0.484 | |
| IgG | 0 (0, 26) | 0 (0, 23) | 0 (0, 31) | 0 (0, 28) | 0 (0, 21) | 0 (0, 22) | ---- | |
| Neutralization | 0 (0, 26) | 0 (0, 23) | 0 (0, 31) | 0 (0, 28) | 0 (0, 21) | 7 (0, 32) | 0.484 | |
| Day 15 | n | 11 | 14 | 11 | 10 | 15 | 14 | |
| IgA | 0 (0, 28) | 0 (0, 23) | 0 (0, 28) | 0 (0, 31) | 0 (0, 22) | 14 (2, 43) | 0.224 | |
| IgG | 0 (0, 28) | 0 (0, 23) | 0 (0, 28) | 0 (0, 31) | 0 (0, 22) | 14 (2, 43) | 0.224 | |
| Neutralization | 0 (0, 28) | 0 (0, 23) | 0 (0, 28) | 0 (0, 31) | 0 (0, 22) | 14 (2, 43) | 0.224 | |
| Day 22 | n | 10 | 11 | 10 | 10 | 15 | 13 | |
| IgA | 0 (0, 31) | 0 (0, 28) | 10 (0, 45) | 10 (0, 45) | 0 (0, 22) | 15 (2, 45) | 0.206 | |
| IgG | 0 (0, 31) | 0 (0, 28) | 20 (3, 56) | 20 (3, 56) | 13 (2, 40) | 23 (5, 54) | 0.639 | |
| Neutralization | 10 (0, 45) | 0 (0, 28) | 10 (0, 45) | 0 (0, 31) | 7 (0, 32) | 15 (2, 45) | 0.583 | |
| Day 29 | n | 11 | 12 | 9 | 9 | 15 | 11 | |
| IgA | 0 (0, 28) | 0 (0, 26) | 0 (0, 34) | 22 (3, 60) | 13 (2, 40) | 18 (2, 52) | 1.000 | |
| IgG | 0 (0, 28) | 0 (0, 26) | 33 (7, 70) | 22 (3, 60) | 13 (2, 40) | 27 (6, 61) | 0.620 | |
| Neutralization | 0 (0, 28) | 0 (0, 26) | 11 (0, 48) | 11 (0, 48) | 7 (0, 32) | 27 (6, 61) | 0.279 | |
| Day 36 | n | 9 | 10 | 9 | 8 | 15 | 12 | |
| IgA | 0 (0, 34) | 0 (0, 31) | 33 (7, 70) | 25 (3, 65) | 13 (2, 40) | 33 (10, 65) | 0.357 | |
| IgG | 0 (0, 34) | 0 (0, 31) | 33 (7, 70) | 38 (9, 76) | 13 (2, 40) | 42 (15, 72) | 0.185 | |
| Neutralization | 0 (0, 34) | 0 (0, 31) | 22 (3, 60) | 13 (0, 53) | 7 (0, 32) | 25 (5, 57) | 0.294 | |
| Day 64 | n | 9 | 9 | 9 | 8 | 14 | 11 | |
| IgA | 0 (0, 34) | 0 (0, 34) | 11 (0, 48) | 38 (9, 76) | 29 (8, 58) | 27 (6, 61) | 1.000 | |
| IgG | 0 (0, 34) | 0 (0, 34) | 33 (7, 70) | 38 (9, 76) | 29 (8, 58) | 45 (17, 77) | 0.434 | |
| Neutralization | 0 (0, 34) | 0 (0, 34) | 33 (7, 70) | 25 (3, 65) | 14 (2, 43) | 27 (6, 61) | 0.623 | |
| Day 85 | n | 8 | 9 | 9 | 8 | 15 | 12 | |
| IgA | 0 (0, 37) | 0 (0, 34) | 11 (0, 48) | 38 (9, 76) | 13 (2, 40) | 25 (5, 57) | 0.628 | |
| IgG | 0 (0, 37) | 0 (0, 34) | 33 (7, 70) | 38 (9, 76) | 27 (8, 55) | 50 (21, 79) | 0.257 | |
| Neutralization | 0 (0, 37) | 0 (0, 34) | 33 (7, 70) | 25 (3, 65) | 13 (2, 40) | 25 (5, 57) | 0.628 | |
| Any Time | n | 12 | 14 | 11 | 11 | 16 | 15 | |
| IgA | 0 (0, 26) | 0 (0, 23) | 27 (6, 61) | 36 (11, 69) | 25 (7, 52) | 33 (12, 62) | 0.704 | |
| IgG | 0 (0, 26) | 0 (0, 23) | 27 (6, 61) | 36 (11, 69) | 25 (7, 52) | 40 (16, 68) | 0.458 | |
| Neutralization | 8 (0, 38) | 0 (0, 23) | 27 (6, 61) | 27 (6, 61) | 13 (2, 38) | 27 (8, 55) | 0.394 | |
Number of subjects (n) and results correspond to mITT population. SL: sublingual dmLT; O: oral dmLT.
a
Represents the percentage of subjects with at least a 4-fold increase compared to pre-dose 1.
b
Numbers in parenthesis represent 95% CI based on an exact binomial distribution (Clopper-Pearson)
*
Fisher’s exact test comparing 4-Fold Rise between Cohort 5 – 25μg SL and Cohort 5 – 25μg Oral