TABLE 1.
Combination parenteral-mucosal immunization regimens with formalin-inactivated C. difficile culture filtrate toxoid
| Regimen | Group | Route (days) | Dosea (μg) | Adjuvant | No. of animals |
|---|---|---|---|---|---|
| Mucosal prime, i.m. boost | A | i.n. (0) | 25 | None | 5 |
| i.m. (14, 28) | 10 | Alum | |||
| B | i.n. (0) | 25 | LT | 5 | |
| i.m. (14, 28) | 10 | Alum | |||
| C | i.g. (0) | 100 | LT | 4 | |
| i.m. (14,28) | 10 | Alum | |||
| D | r. (0) | 100 | LT | 5 | |
| i.m. (14, 28) | 10 | Alum | |||
| E | i.m. (0, 14, 28) | 10 | Alum | 5 | |
| F | No treatment | ||||
| i.m. prime, mucosal boost | A | i.m. (0) | 10 | Alum | 5 |
| i.n. (14, 21, 28) | 25 | None | |||
| B | i.m. (0) | 10 | Alum | 4 | |
| i.n. (14, 21, 28) | 25 | LT | |||
| C | i.m. (0) | 10 | Alum | 5 | |
| i.g. (14, 21, 28) | 100 | LT | |||
| D | i.m. (0) | 10 | Alum | 5 | |
| r. (14, 21, 28) | 100 | LT | |||
| E | No treatment | 5 |
a
Based on the toxin A concentration as determined by ELISA prior to formaldehyde inactivation.