Table 3.
Vaccine-site reactions by dose.
| Vaccine Site Solicited Symptom and Severity [N (%)] |
||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pain |
Pruritus |
Erythema |
Swelling |
Induration |
||||||||||||
| Cohort | Dose | Mild | Mod | Sev | Mild | Mod | Sev | Mild | Mod | Sev | Mild | Mod | Sev | Mild | Mod | Sev |
| A-1 | 1 (n = 5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 2 (n = 5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| 3 (n = 5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| A-2 | 1 (n = 5) | 1 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 2 (n = 4) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| 3 (n = 4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (100.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| B | 1 (n = 10) | 1 (10.0) | 0 (0.0) | 0 (0.0) | 1 (10.0) | 0 (0.0) | 0 (0.0) | 4 (40.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 2 (n = 10) | 1 (10.0) | 0 (0.0) | 0 (0.0) | 1 (10.0) | 0 (0.0) | 0 (0.0) | 2 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| 3 (n = 9) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| C | 1 (n = 10) | 4 (40.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (40.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 2 (n = 9) | 2 (22.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 6 (66.7) | 0 (0.0) | 0 (0.0) | 1 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| 3 (n = 9) | 2 (22.2) | 0 (0.0) | 0 (0.0) | 1 (11.1) | 0 (0.0) | 0 (0.0) | 6 (66.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 6 (66.7) | 0 (0.0) | 0 (0.0) | |
| D | 1 (n = 10) | 6 (60.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 2 (n = 10) | 4 (40.0) | 0 (0.0) | 0 (0.0) | 2 (20.0) | 0 (0.0) | 0 (0.0) | 5 (50.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (30.0) | 0 (0.0) | 0 (0.0) | |
| 3 (n = 10) | 6 (60.0) | 1 (10.0) | 0 (0.0) | 6 (60.0) | 0 (0.0) | 0 (0.0) | 8 (80.0) | 0 (0.0) | 0 (0.0) | 1 (10.0) | 0 (0.0) | 0 (0.0) | 5 (50.0) | 0 (0.0) | 0 (0.0) | |
| E | 1 (n = 10) | 2 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (10.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (20.0) | 0 (0.0) | 0 (0.0) |
| 2 (n = 10) | 5 (50.0) | 1 (10.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 7 (70.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (40.0) | 0 (0.0) | 0 (0.0) | |
| 3 (n = 9) | 4 (44.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 6 (66.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 6 (66.7) | 0 (0.0) | 0 (0.0) | |
Two subjects (1 in Cohort B and 1 in Cohort C) had bruising at the vaccination site.
One subject (Cohort E) had vaccine-site discoloration and a papule at the vaccination site after second and third vaccinations.
Adverse event severity was characterized as mild: not interfering with routine activities; moderate (mod): interfering with but not precluding routine activities; severe (sev): preventing routine activities.