Table 4.
Proportion of Subjects Demonstrating an Immunologic Response (Serology, ALS) to Immunizing Antigens.
| Study Cohort [n (%)] |
|||||||
|---|---|---|---|---|---|---|---|
| Antigen | Assay | A-1 5 µg CssBA (N = 5) |
A-2 0.1 µg dmLT (N = 4) |
B 5 µg CssBA + 0.1 µg dmLT (N = 9)a |
C 5 µg CssBA+ 0.5 µg dmLT (N = 9) |
D 15 µg CssBA+ 0.5 µg dmLT (N = 10) (N = 10) |
E 45 µg CssBA+ 0.5 µg dmLT (N = 10) |
| Coli Surface Antigen 6 (CS6) | Serology (IgA) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (44.4) | 3 (30.0) | 5 (50.0) |
| Serology (IgG) | 1 (20.0) | 0 (0.0) | 7 (77.8) | 9 (100.0) | 10 (100.0) | 9 (90.0) | |
| ALS (IgA) | 0 (0.0) | 0 (0.0) | 3 (33.3) | 8 (88.9) | 8 (80.0) | 10 (100.0) | |
| ALS (IgG) | 3 (60.0) | 0 (0.0) | 8b (100.0) | 8 (88.9) | 10 (100.0) | 8 (80.0) | |
| Heat labile toxin (LT) | Serology (IgA) | 0 (0.0) | 2 (50.0) | 2 (22.2) | 7 (77.8) | 5 (50.0) | 7 (70.0) |
| Serology (IgG) | 0 (0.0) | 4 (100.0) | 6 (66.7) | 9 (100.0) | 9 (90.0) | 10 (100.0) | |
| ALS (IgA) | 0 (0.0) | 4 (100.0) | 2 (22.2) | 7 (77.8) | 9 (90.0) | 10 (100.0) | |
| ALS (IgG) | 0 (0.0) | 4 (100.0) | 8b (100.0) | 9 (100.0) | 10 (100.0) | 10 (100.0) | |
Responder defined as ≥ 4-fold rise in baseline reciprocal endpoint titer.
a
One subject excluded because the subject only had one sample post vaccination despite receiving two vaccinations.
b
One subject excluded because the subject only had one ALS sample post vaccination despite receiving two vaccinations.