TABLE 4.
Number of subjects with mucosal immune responses to CFA/IIa after one or two oral doses of attenuated ETEC strain PTL-002 or PTL-003
| Assay | Immunoglobulin | Vaccine | No. of respondersb (%) after one dose | No. of new responders (%) after second dosec | Total no. of responders (%) after one or two doses | Pd |
|---|---|---|---|---|---|---|
| ASC | IgA | PTL-002 | 10/20 (50) | 1/4 (25) | 11/20 (55) | 0.01 |
| PTL-003 | 15/20 (75) | 3/5 (60) | 18/20 (90) | |||
| IgG | PTL-002 | 6/20 (30) | 0/7 (0) | 6/20 (30) | 0.20 | |
| PTL-003 | 9/20 (45) | 1/7 (14) | 10/20 (50) | |||
| ALS | IgA | PTL-002 | 9/20 (45) | 0/5 (0) | 9/20 (45) | 0.06 |
| PTL-003 | 11/20 (55) | 4/7 (57) | 15/20 (75) | |||
| IgG | PTL-002 | 3/20 (15) | 1/8 (13) | 4/20 (20) | 0.17 | |
| PTL-003 | 6/20 (30) | 2/9 (22) | 8/20 (40) |
a
The response in the ASC assay is ≥2-fold increase over the baseline and >1.0 spots/106 PBMC. The response in the ALS assay is ≥2-fold increase over the baseline.
b
Responders/total number of subjects in group (%).
c
Subjects in the two-dose group who did not respond to the first dose but did respond to the second dose given on day 10/all subjects in the two-dose group who did not respond to the first dose (%).
d
Chi-square or Fisher's exact test comparison of total responders to PTL-002 versus total responders to PTL-003.