Table 3.
Summary of serum IgA and IgG responses, by dose
Response | GMT, EU/ml (95% CI)a |
|||
---|---|---|---|---|
5 μg (n = 5 subjects)b | 25 μg (n = 6 subjects) | 50 μg (n = 12 subjects) | 100 μg (n = 12 subjects) | |
Anti-dmLT serum IgA | ||||
Baseline | 124 (25, 620) | 130 (77, 219) | 211 (119, 373) | 311 (185, 525) |
Day 8 | 167 (28, 994) | 264 (46, 1,527) | 822 (358, 1,885) | 591 (233, 1,501) |
Day 14 | 177 (32, 977) | 263 (51, 1,350) | 1,490 (497, 4,464) | 675 (280, 1,631) |
Day 28 | 164 (33, 827) | 328 (109, 990) | 1,030 (368, 2,882) | 800 (412, 1,553) |
Total no. of responders (%)c | 0/5 (20) | 1/6 (16.7) | 8/12 (66.7) | 4/12 (33.3) |
Anti-dmLT serum IgG | ||||
Baseline | 369 (158, 864) | 424 (107, 1,675) | 573 (250, 1,315) | 514 (286, 924) |
Day 8 | 487 (136, 1,744) | 627 (89, 4,414) | 1,872 (526, 6,655) | 1,063 (359, 3,148) |
Day 14 | 615 (111, 3,404) | 756 (93, 6,138) | 3,494 (776, 15,723) | 1,215 (352, 4,190) |
Day 28 | 583 (117, 2,913) | 853 (111, 6,536) | 3,120 (697, 13,977) | 1,739 (574, 5,272) |
Total no. of responders (%)c | 1/5 (20) | 1/6 (16.7) | 7/12 (58.3) | 4/12 (33.3) |
Values are GMT (95% CI) unless otherwise stated.
A nonassociated death occurred prior to the collection of the day 8 specimen.
A 4-fold increase in antibody over baseline, at any time postvaccination.