Table 1.
Baseline Characteristics
| Characteristic | Treatment Group | ||
|---|---|---|---|
| Cohort 1 (Single Dose)a (n = 10) | Cohort 2 (2 Doses)a,b (n = 11) | Total (N = 21) | |
| Male sex, No. (%) | 6 (60) | 5 (45) | 11 (52) |
| Race/ethnicity, No. (%) | |||
| Black | 8 (80) | 11 (100) | 19 (90) |
| White | 2 (20) | 0 (0) | 2 (10) |
| Hispanic/Latino | 1 (10) | 0 (0) | 1 (5) |
| Infant ARV, No. (%) | |||
| 3TC, ZDV, NVP | 2 (20) | 0 (0) | 2 (10) |
| NVP | 2 (20) | 11 (100) | 13 (62) |
| ZDV | 5 (50) | 0 (0) | 5 (24) |
| ZDV, NVP | 1 (10) | 0 (0) | 1 (5) |
| Age, d, at VRC01LS administration | |||
| Mean (SD) | 2.0 (0.9) | 2.4 (0.8) | 2.2 (0.9) |
| Median (Q1, Q3) | 2 (2, 3) | 2 (2, 3) | 2 (2, 3) |
| Min, max | 0, 3 | 1, 4 | 0, 4 |
| Weight at birth, g | |||
| Mean (SD) | 3123 (534) | 2948 (381) | 3031 (457) |
| Median (Q1, Q3) | 2865 (2750, 3520) | 2920 (2550, 3330) | 2880 (2700, 3330) |
| Min, max | 2535, 4045 | 2500, 3545 | 2500, 4045 |
| Enrollment site, No. (%) | |||
| Africac | 3 (30) | 11 (100) | 14 (67) |
| United States | 7 (90) | 0 (0) | 7 (33) |
Abbreviations: 3TC, lamivudine; ARV, antiretroviral; NVP, nevirapine; Q1, quartile 1; Q3, quartile 3; SD, standard deviation; ZDV, zidovudine.
aDose 1: 80 mg VRC01LS; dose 2: 100 mg VRC01LS.
bCohort 2 required breastfeeding.
cCape Town, South Africa, and Harare, Zimbabwe.