Table 3:
HIV disease progression (intention-to-treat population)
| RTS,S/AS01vaccine (n=99) | Rabies vaccine (n=101) | |
|---|---|---|
|
| ||
| HIV viral load, copies per mL | ||
| Screening | 149 000 (7490–750 000) | 157 000 (3630–750 000) |
| 1 month after dose 3 | 3125 (0–221 500) | 584 (0–136 100) |
| 6 months after dose 3 | 3790 (0–147 000) | 400 (0–103 000) |
| 12 months after dose 3 | 947 (0–99 400) | 400 (0–106 000) |
| CD4 percentage cell count | ||
| Screening | 27% (21–32) | 26% (21–31) |
| 1 month after dose 3 | 30% (24–35) | 31% (24–35) |
| 6 months after dose 3 | 32% (27–40) | 32% (25–38) |
| 12 months after dose 3 | 34% (26–41) | 32% (26–38) |
| CD4 absolute cell count, cells per μL | ||
| Screening | 1995 (1325–2683) | 1896 (1408–2447) |
| 1 month after dose 3 | 1879 (1372–2801) | 2078 (1562–2548) |
| 6 months after dose 3 | 2066 (1411–3004) | 1857 (1378–2542) |
| 12 months after dose 3 | 1838 (1286–2537) | 1784 (1296–2460) |
| WHO HIV/AIDS clinical stage at each timepoint | ||
| Stage 1 | ||
| Screening | 81 (82%) | 82 (81%) |
| 1 month after dose 1 | 75 (77%) | 72 (71%) |
| 1 month after dose 2 | 79 (81%) | 77 (77%) |
| 1 month after dose 3 | 76 (81%) | 76 (78%) |
| 6 months after dose 3 | 74 (82%) | 72 (77%) |
| 12 months after dose 3 | 74 (80%) | 69 (73%) |
| Stage 2 | ||
| Screening | 18 (18%) | 19 (19%) |
| 1 month after dose 1 | 19 (19%) | 27 (27%) |
| 1 month after dose 2 | 15 (16%) | 20 (20%) |
| 1 month after dose 3 | 12 (13%) | 19 (19%) |
| 6 months after dose 3 | 12 (13%) | 16 (17%) |
| 12 months after dose 3 | 10 (11%) | 18 (19%) |
| Stage 3 | ||
| Screening | 0 (0%) | 0 (0%) |
| 1 month after dose 1 | 2 (2%) | 1 (1%) |
| 1 month after dose 2 | 1 (1%) | 2 (2%) |
| 1 month after dose 3 | 4 (4%) | 0 (0%) |
| 6 months after dose 3 | 0 (0%) | 3 (3%) |
| 12 months after dose 3 | 3 (3%) | 1 (1%) |
| Stage 4 | ||
| Screening | 0 (0%) | 0 (0%) |
| 1 month after dose 1 | 0 (0%) | 0 (0%) |
| 1 month after dose 2 | 0 (0%) | 0 (0%) |
| 1 month after dose 3 | 0 (0%) | 0 (0%) |
| 6 months after dose 3 | 0 (0%) | 0 (0%) |
| 12 months after dose 3 | 0 (0%) | 2 (2%) |
| Deceased* | ||
| Screening | 0 (0%) | 0 (0%) |
| 1month after dose 1 | 2 (2%) | 1 (1%) |
| 1 month after dose 2 | 2 (2%) | 1 (1%) |
| 1 month after dose 3 | 2 (2%) | 2 (2%) |
| 6 months after dose 3 | 4 (4%) | 3 (3%) |
| 12 months after dose 3 | 5 (5%) | 4 (4%) |
Data are median (IQR) or n (%).
*
The number of deceased children at each timepoint is cumulative and the overall mortality is presented in table 2 as the number of children with at least one fatal serious adverse event.