Table 3. Seropositivity rates and geometric mean concentrations for anti-CS antibodies at screening and 1 month post-dose 3 in RTS,S/AS01- and comparator-vaccinated HIV-infected participants (per protocol population for immunogenicity of HIV-infected participants).
| Time point | R3C + R3R | C3C | ||||
|---|---|---|---|---|---|---|
| N | % with anti-CS ≥ 0.5 EU/mL (95% CI) | GMC (95% CI), EU/mL | N | % with anti-CS ≥ 0.5 EU/mL (95% CI) | GMC (95% CI), EU/mL | |
| Pooled across age categories | ||||||
| Screening | 53 | 15.1 (6.7–27.6) | 0.3 (0.3–0.4) | 21 | 23.8 (8.2–47.2) | 0.3 (0.3–0.4) |
| 1 month post-dose 3 | 53 | 100 (93.3–100) | 188.7 (115.2–309.0) | 22 | 18.2 (5.2–40.3) | 0.5 (0.2–1.1) |
| 5–17 months | ||||||
| Screening | 28 | 14.3 (4.0–32.7) | 0.3 (0.2–0.5) | 16 | 31.3 (11.0–58.7) | 0.4 (0.3–0.5) |
| 1 month post-dose 3 | 29 | 100 (88.1–100) | 264.7 (137.5–509.6) | 17 | 23.5 (6.8–49.9) | 0.5 (0.2–1.7) |
| 6–12 weeks | ||||||
| Screening | 25 | 16.0 (4.5–36.1) | 0.3 (0.2–0.4) | 5 | 0.0 (0.0–52.2) | 0.3 (0.3–0.3) |
| 1 month post-dose 3 | 24 | 100 (85.8–100) | 125.3 (58.1–270.3) | 5 | 0.0 (0.0–52.2) | 0.3 (0.3–0.3) |
CS, circumsporozoite; R3R, group receiving 4 doses of RTS,S/AS01; R3C, group receiving 3 doses of RTS,S/AS01 plus 1 dose of comparator vaccine; C3C, group receiving 4 doses of comparator vaccine; N, number of participants in the per protocol population with available results, including only those confirmed as HIV-infected by 2 May 2012 (data lock point when most children had performed their study month 20 visit); % with anti-CS ≥ 0.5 EU/mL, percentage of participants with an anti-CS antibody concentration ≥ 0.5 EU/mL; EU, enzyme-linked immunosorbent assay unit; CI, confidence interval; GMC, geometric mean concentration.