Table 2. Summary of dermal dose site findings.
Summary of all dose site dermal observations over the in-life portion of the study. Injection sites A and B (left and right thigh muscle, respectively) comprised the IM vaccine and adjuvant control dosing locations. Injection sites C, D, E, and F (upper left, upper right, lower left, and lower right dorsal regions, respectively) comprised the subcutaneous (SC) Oxycodone challenge dosing sites. All dosing sites were scored using a modified Draize technique and the signs scored included atonia, desquamation, edema, erythema, eschar, and fissuring. Observations for sites A and B were performed prior to dosing and approximately 1, 6, and 24 hours post dosing on Days 1, 15, 29, and 43. Observations for dose sites C, D, E and F were performed prior to the first oxycodone dose and once after each dose at approximately 45 ± 15 minutes on Days 51 through 57 of the dosing phase. Data are presented as the total number of non-normal signs observed per the total number of observations for all animals in the treatment group at any time throughout the study.
| Group Details | Vaccination Sites1 |
Oxycodone Challenge Sites2 | |||||||
|---|---|---|---|---|---|---|---|---|---|
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| Group # |
Sex | Phase | N | A | B | C | D | E | F3 |
| 1 | M | Dosing | 15 | 0/105 | 0/60 | 0/30 | - | 0/68 | 0/2 |
| 2 | M | Dosing | 10 | 0/70 | 1/40 | 0/20 | - | 0/50 | - |
| 3 | M | Dosing | 15 | 0/105 | 0/60 | 0/30 | - | 0/69 | - |
| 4 | M | Dosing | 10 | 0/70 | 0/30 | - | - | - | - |
| 1 | F | Dosing | 15 | 0/105 | 0/60 | 0/30 | 0/60 | 0/15 | - |
| 2 | F | Dosing | 10 | 0/70 | 0/40 | 0/20 | 0/40 | 0/10 | - |
| 3 | F | Dosing | 15 | 0/105 | 0/60 | 0/30 | 0/60 | 0/15 | - |
| 4 | F | Dosing | 10 | 0/90 | 0/50 | - | - | - | - |
IM sites on the left (site A) or right (site B) thigh
SC sites in the upper left (site C), upper right (site D), lower left (site E), and lower right (site F) dorsal regions
Only 1 animal in Group 1 (male) was injected in site F