Table 3.
VRC01 Pharmacologic Measures When Administered as a Single Subcutaneous Dose to Neonates Born to Women With HIVa
| Pharmacokinetic Parameter | Dose Group | Mean | SD | Median |
|---|---|---|---|---|
| VRC01 C28D (mcg/mL) | 1–20 mg/kg | 39.3 | 14.9 | 39.2 |
| VRC01 C28D (mcg/mL) | 2–40 mg/kg | 78.2 | 21.9 | 75.3 |
| VRC01 C28D (mcg/mL) | 3–40 mg/kg | 130.1 | 34.2 | 124.2 |
| VRC01 C56D (mcg/mL) | 1–20 mg/kg | 12.84 | 4.19 | 13.64 |
| VRC01 C56D (mcg/mL) | 2–40 mg/kg | 45.29 | 19.16 | 47.23 |
| VRC01 C112D (mcg/mL) | 1–20 mg/kg | 3.64 | 2.85 | 3.99 |
| VRC01 C112D (mcg/mL) | 2–40 mg/kg | 19.48 | 17.88 | 10.62 |
| C max (mcg/mL) | 1–20 mg/kg | 226.6 | 30.8 | 233.3 |
| C max (mcg/mL) | 2–40 mg/kg | 387.1 | 82.7 | 385.1 |
| T max (days) | 1–20 mg/kg | 2.33 | 1.85 | 1.58 |
| T max (days) | 2–40 mg/kg | 1.34 | 0.96 | 0.95 |
| AUC (mcg × d/mL) | 1–20 mg/kg | 3971 | 1024 | 3801 |
| AUC (mcg × d/mL) | 2–40 mg/kg | 9250 | 2473 | 9520 |
Abbreviations: AUC, area under the concentration versus time curve; Cmax, maximum concentration; d, day; HIV, human immunodeficiency virus; mcg, micrograms; SD, standard deviation; Tmax, time of maximum concentration.
aVRC01 dose administered within 72 hours of birth for Dose Groups 1 and 2 and within 5 days of birth for Dose Group 3.