Table I. Overview of cynomolgus macaques (NHPs), vaccine groups, and dermal inoculation-site observations.
| Draize Scores |
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Edemaa |
Erythemab |
Eschar |
Lymphadenopathy |
||||||||
| Vaccine Group | Vaccine | NHP ID | Inoc. No. | Max. Score | Days | Max. Score | Days | Max. Score | Days | Regional | General |
| Group 1a | None (PBS) | 8749 | 9 | B | B | B | D2 | 5 | 16 | ||
| None (PBS) | 6741 | 3 | 3 | 12–14 | 3 | 12–16 | 3 | 12–19 | 5 | 7 | |
| Group 1b | None (pVR1012) | 5671 | 8 | 3 | 12–14 | 3 | 9–14 | 3 | 12–16 | 5 | 9 |
| Group 1c | None (pGM-CSF) | 8824 | 12 | 3 | 12–14 | 3 | 12–14 | 3 | 9–14 | 7 | 16 |
| None (pGM-CSF) | 5199 | 6 | 3 | 12–14 | 4 | 14–16 | 3 | 12–19 | 5 | 16 | |
| Group 1d | None (mSEB-VRP) | 6856 | 18 | B | B | B | D7 | 5 | 9 | ||
| Group 2 | Kp47/47-VRP | 5747 | 4 | 3 | 9–16 | 4 | 9–14 | 4 | 9–16 | 5 | 16 |
| Kp47/47-VRP | 8984 | 10 | 3 | 9–14 | 4 | 9–14 | 4 | 12–14 | 5 | 7 | |
| Group 3.1 | pKarp47 (2 mg ×3) | 6537 | 13 | 0 | — | 0 | — | NE | — | 5 | 16 |
| pKarp47 (2 mg ×3) | 5732 | 1 | 3 | 12–16 | 3 | 14–16 | 3 | 16–21 | 5 | 16 | |
| Group 3.2 | pKarp47 (1 mg ×3) | 5253 | 19 | B | B | B | D2 | 7 | 7 | ||
| pKarp47 (1 mg ×3) | 7416 | 7 | 3 | 16–19 | 3 | 16–19 | NE | — | 9 | 16 | |
| Group 3.3 | pKarp47 (0.5 mg ×3) | 5817 | 15 | 0 | — | 0 | — | NE | — | 7 | 28 |
| pKarp47 (0.5 mg ×3) | 5601 | 16 | 0 | — | 0 | — | NE | — | 7 | 14 | |
| Group 4.1 | pKarp47 (2 mg ×2+VRP) | 5689 | 2 | 2 | 12–14 | 2 | 12–14 | NE | — | 5 | 9 |
| pKarp47 (2 mg ×2+VRP) | 6985 | 14 | 3 | 16–19 | 3 | 16–19 | 3 | 16–23 | 5 | 7 | |
| Group 4.2 | pKarp47 (1 mg ×2+Kp47/47-VRP) | 2660 | 20 | 0 | — | 0 | — | NE | — | 5 | 19 |
| pKarp47 (1 mg ×2+Kp47/47-VRP) | 5234 | 5 | B | B | B | D7 | 5 | 9 | |||
| Group 4.3 | pKarp47 (0.5 mg ×2+Kp47/47-VRP) | 5235 | 11 | 2 | 14–16 | 3 | 12–14 | 3 | 12–19 | 5 | 12 |
| pKarp47 (0.5 mg ×2+Kp47/47VRP) | 7982 | 17 | 3 | 16–19 | 4 | 16–19 | 4 | 16–26 | 5 | 12 | |
Highest scores for edema, erythema, and eschar are noted and time period they were observed in days postinoculation. Lymphadenopathy denotes the first day of clinical enlargement of regional (draining) lymph nodes and generalized lymph nodes.
Edema scores: 0, none (no swelling); 1, minimal (slight swelling); 2, mild (defined swelling [distinct]); 3, moderate (defined swelling [raised]). Erythema scores: 0, none (normal color); 1, minimal (light pink); 2, mild (bright pink/pale red); 3, moderate (bright red); 4, severe (dark red).
Eschar scores: 1, papule (induration and inflammation); 2, excoriation (induration and central lesion); 3, central necrosis (central lesion with raised induration around the lesion, <10 mm); 4, central necrosis and raised induration (large central ulceration and black crust, >10 mm).
B, biopsy; Inoc., inoculation; Max. maximum; NE, no eschar.