Table 1.
Maternal demographic and clinical characteristics at time of enrolment and delivery outcomes
| Single-dose group (n=266) | Double-dose group (n=265) | Two-single-doses group (n=269) | Total population (n=800) | ||
|---|---|---|---|---|---|
| Demographic and clinical characteristics | |||||
| Age, years | 28·8 (5·0) | 29·0 (4·8) | 28·4 (4·9) | 28·7 (4·9) | |
| Gestational age at enrolment, weeks | 23·4 (6·0) | 24·2 (6·1) | 23·8 (5·6) | 23·8 (5·9) | |
| Primigravida women | 30 (11%) | 40 (15%) | 31 (12%) | 101 (13%) | |
| CD4 count within 2 weeks of enrolment | |||||
| n | 257 | 255 | 263 | 775 | |
| Mean, cells per μL | 458·7 (260·5) | 463·9 (256·5) | 454·4 (227·6) | 459·0 (248·2) | |
| <350 cells per μL | 99/257 (39%) | 91/255 (36%) | 98/263 (37%) | 288/775 (37%) | |
| HIV viral load within 2 weeks of enrolment | |||||
| n | 245 | 243 | 249 | 737 | |
| Median, copies per mL* | 4918 (475–34 863) | 7298 (511–32 360) | 5152 (711–28 486) | 6066 (524–33 044) | |
| <40 copies per mL | 65/245 (27%) | 59/243 (24%) | 72/249 (29%) | 196/737 (27%) | |
| Antiretroviral therapy at enrolment | 248/263 (94%) | 250/262 (95%) | 256/267 (96%) | 754/792 (95%) | |
| On antiretroviral therapy for ≥30 days | 129/255 (51%) | 126/255 (49%) | 143/265 (54%) | 398/775 (51%) | |
| Delivery outcomes | |||||
| Known delivery outcome | 262 (98%)† | 253 (95%) | 259 (96%) | 774 (97%)† | |
| Number of twin pregnancies | 9/262 (3%) | 12/253 (5%) | 9/259 (3%) | 30/774 (4%) | |
| Days between first injection and delivery‡ | 102·9 (45·9) | 96·9 (45·6) | 98·8 (42·8) | 99·6 (44·8) | |
| Delivered <28 days after first injection‡ | 9/262 (3%) | 8/253 (3%) | 13/259 (5%) | 30/774 (4%) | |
| Delivered <28 days after second injection‡ | 47/262 (18%) | 54/253 (21%) | 44/259 (17%) | 145/774 (19%) | |
| Birth outcomes known | 270†§ | 265 | 268¶ | 803†§ | |
| Fetal deaths | 5/270 (2%) | 5/265 (2%) | 11/268 (4%) | 21/803 (3%) | |
| Livebirths | 265 | 260 | 257 | 782 | |
| Births <37 weeks of gestation|| | 48/264 (18%) | 38/260 (15%) | 50/257 (19%) | 136/781 (17%) | |
| Birthweight, kg|| | 2·9 (0·6) | 2·9 (0·6) | 2·9 (0·6) | 2·9 (0·6) | |
| Neonates with <2500 g birthweight|| | 52/263 (20%) | 53/260 (20%) | 50/256 (20%) | 155/779 (20%) | |
| Infants exclusively breastfed at birth visit | 103/247 (42%) | 103/235 (44%) | 96/239 (40%) | 302/721 (42%) | |
Data are mean (SD), median (IQR), n (%), or n/N (%).
*
Excludes participants with a viral load of <40 copies per mL HIV.
†
Excluding one woman who died while pregnant.
‡
Based on women with known delivery outcomes.
§
Excluding one woman who had a therapeutically indicated medical termination of pregnancy.
¶
14 birth outcomes occurred before second vaccination visit.
||
Based on livebirths.