Table 1. Scheme of toxicity study in naive mice.
| DNA dose (μg) | Number of doses | Day(s) of immunization | Day(s) of samplinga after last dosing | Number of animals (males, females) |
|---|---|---|---|---|
| 10 | 1 | 1 | 1 | 10 (5, 5) |
| 5 | 1, 8, 15, 22, 29 | 1, 14 | 20 (10, 10) | |
| 5b | 1, 8, 15, 22, 29 | 1, 14 | 20 (10, 10) | |
| 50 | 1 | 1 | 1 | 10 (5, 5) |
| 5 | 1, 8, 15, 22, 29 | 1, 14 | 20 (10, 10) | |
| 5b | 1, 8, 15, 22, 29 | 1, 14 | 20 (10, 10) | |
| 100 | 1 | 1 | 1 | 10 (5, 5) |
| 5 | 1, 8, 15, 22, 29 | 1, 14, 61 | 30 (15, 15) | |
| 5b | 1, 8, 15, 22, 29 | 1, 14, 61 | 30 (15, 15) | |
| Placebo | 1 | 1 | 1 | 10 (5, 5) |
| 5 | 1, 8, 15, 22, 29 | 1, 14, 61 | 30 (15, 15) | |
| 5b | 1, 8, 15, 22, 29 | 1, 14, 61 | 30 (15, 15) |
a
Per day of sampling, five male and five female animals per group were killed.
b
Satellite group to assess biologic activity of the vaccine lot and induction of antibodies against dsDNA.