Table 3.
VRC01LS Pharmacokinetic Measures When Administered as 1 or 2 Subcutaneous Doses to Neonates Born to Women With Human Immunodeficiency Virus
| Pharmacokinetic Parameter | Mean (SD) | |
|---|---|---|
| Dose 1 | Dose 2 | |
| Dose, mg/kg | 28.8 vs 28.5 (4.1)a | 17.2 (2.0) |
| AUC0-∞, µg × d/mL | 11 589 (2064) | NA |
| AUC0-84D, µg × d/mL | 9041 (2047) | 8839 (1891) |
| λ z, per day | 0.0169 (0.0019) | 0.0190 (0.0025) |
| T1/2λz, d | 41.3 (4.3) | 37.1 (4.9) |
| CL/F, mL/d/kg | 2.35 (0.34) | NA |
| Cmax, µg/mL | 227.1 (67.6) | NA |
| Tmax, d | 0.5 (0.75) | NA |
| VRC01LS C4WK, µg/mL | 113.6 (31.0) | 139.3 (29.6) |
| VRC01LS C12WK, µg/mL | 44.0 (11.6) | 52.2 (17.5) |
| VRC01LS C24WK, µg/mL | 10.2 (3.1) | 10.1 (5.1) |
Abbreviations: λ z, terminal slope; AUC, area under the concentration–time curve; C4WK, C12WK, C24WK, concentrations at week 4, week 12, and week 24; CL/F, clearance; Cmax, maximum concentration; NA, not applicable; SD, standard deviation; T1/2, half-life; Tmax, time of maximum concentration.
aThe mean dose in mg/kg for dose 1 in cohort 1 and cohort 2.