Table 2.
Method in brief of study/analyses of toxicity in animals due to cGLP LdCen1−/−.
| Study name | Route of administration SC/ID & other details |
Groups and sex (6 animals in each group) |
Treatment | Study details |
|---|---|---|---|---|
|
STUDY I Single dose toxicity study in Hamsters |
SC Analysed on day 15 |
G1 (3♂ & 3♁) | G1: Placebo |
Clinical observations: General and local examinations till 4 h after vaccination on Day 1 and once daily thereafter Body weights & Food consumption: On Day 0, 4, 8 and 15 Gross pathology: Day 15, gross lesions if any were collected |
| G2 (3♂ & 3♁) | G2: 1X vaccine | |||
| G3 (3♂ & 3♁) | G3: 3X vaccine | |||
|
ID Analysed on day 15 |
G4 (3♂ & 3♁) | G4: Placebo | ||
| G5 (3♂ & 3♁) | G5: 1X vaccine | |||
| G6 (3♂ & 3♁) | G6: 3X vaccine | |||
|
STUDY II Double dose toxicity study in Hamsters |
SC First immunization on day 0. Analyse on day 30 |
G1 (3♂ & 3♁) | G1: Placebo |
Clinical observations: General and local examinations till 4 h after vaccinations and once daily thereafter Body weights & Food consumption: weekly study Necropsy & Gross pathology: Day 30 and day 90, gross lesions if any were collected. Detailed pathology in individual organs including their weight |
| G2 (3♂ & 3♁) | G2: 1X vaccine | |||
| G3 (3♂ & 3♁) | G3: 3X vaccine | |||
|
SC Second immunization on day 30. Analyse on day 90 |
G4 (3♂ & 3♁) | G4: Placebo | ||
| G5 (3♂ & 3♁) | G5: 1X vaccine | |||
| G6 (3♂ & 3♁) | G6: 3X vaccine | |||
|
STUDY III Single dose toxicity study in dogs |
SC Analysed on day 15 |
G1 (3♂ & 3♁) | G1: Placebo |
Clinical observations: General and local examinations till 4 h after vaccination and once daily thereafter Body weights & Food consumption: On day 1, 4, 8 and 15 Rectal temperature: On day 1 and 2 Necropsy and Histopathology: day 15, All lesions if any were collected |
| G2 (3♂ & 3♁) | G2: 1X vaccine | |||
| G3 (3♂ & 3♁) | G3: 3X vaccine |