Table 3.
Day 8 Laboratory Safety Parameters, by Dose Group
| Laboratory Parameter | 1.35 × 105 (n = 18) | 2.7 × 105 (n = 18) | 4.5 × 105 (n = 24) | 9 × 105 (n = 27) | 1.8 × 106 (n = 24) | All Vaccine (n = 111) | Placebo (n = 53) |
|---|---|---|---|---|---|---|---|
| Hemoglobin | 1 (5.6) | 5 (27.8) | 6 (25.0) | 6 (22.2) | 5 (20.8) | 23 (20.7) | 15 (28.3) |
| White blood cells | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (11.1) | 0 (0.0) | 3 (2.7) | 3 (5.7) |
| Platelets | 0 (0.0) | 0 (0.0) | 1 (4.2) | 1 (3.7) | 0 (0.0) | 2 (1.8) | 2 (3.8) |
| Neutrophil count | 1 (5.6) | 3 (16.7) | 1 (4.2) | 3 (11.1) | 0 (0.0) | 8 (7.2) | 4 (7.5) |
| ALT | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.9) | 2 (3.8) |
| Creatinine | 0 (0.0) | 0 (0.0) | 1 (4.2) | 0 (0.00) | 1 (4.2) | 2 (1.8) | 1 (1.9) |
Data are no. (%) of subjects with abnormal laboratory values. One subject in the 2.7 × 105 group terminated early before follow-up labs were collected. Abnormal laboratory values are all grade 1 or grade 2, defined per the protocol-defined toxicity ranges postvaccination (Supplementary Tables 1 and 2). No grade 3 laboratory abnormalities occurred.
Abbreviation: ALT, alanine aminotransferase.