Table 3. Immune responses before vaccination and at 1 month after the third dose of RTS,S/AS01 vaccine (RTS,S coad and RTS,S alone groups) and prior to and at 1 month after the MR and YF vaccination (RTS,S coad and Control groups) - per-protocol set.
Antibody | Parameter | Timepoint | RTS,S coad | RTS,S alone | Control | |||
---|---|---|---|---|---|---|---|---|
N | Value (95% CI) | N | Value (95% CI) | N | Value (95% CI) | |||
Anti-CS | Seropositivity rate (concentration ≥ 1.9 | Pre | 209 | 0.5 (0.0–2.6) | 218 | 0.9 (0.1–3.3) | – | – |
EU/mL) | Post | 207 | 99.5 (97.3–100.0) | 213 | 100.0(98.3–100.0) | – | – | |
GMC (EU/mL) | Pre | 209 | 0.96 (0.94–0.97) | 219 | 0.96 (0.94–0.98) | – | – | |
Post | 207 | 452.87 (406.99–503.92) | 219 | 422.49 (385.42–463.12) | – | – | ||
Anti-HBs | Seropositivity rate (concentration ≥ 6.2 | Pre | 206 | 97.1 (93.8–98.9) | 213 | 97.2 (94.0–99.0) | – | – |
mIU/mL) | Post | 204 | 100.0 (98.2–100.0) | 210 | 100.0 (98.3–100.0) | – | – | |
GMC (mIU/mL) | Pre | 206 | 393.29 (315.23–490.66) | 213 | 420.79 (335.10–528.39) | – | – | |
Post | 204 | 42096.33 (35558.62–49836.05) | 210 | 43261.19 (37275.19–50208.47) | − | − | ||
Seroprotection rate (concentration ≥ 10 | Pre | 206 | 95.6 (91.9–98.0) | 213 | 96.2 (92.7–98.4) | – | – | |
mIU/mL) | Post | 204 | 100.0 (98.2–100.0) | 210 | 100.0 (98.3–100.0) | – | – | |
Anti- | measles | Seropositivity rate | Pre | 206 | 0.0 | (0.0–1.8) | ||
− | − | (concentration ≥ 150 mIU/mL) | 220 | 0.0 (0.0–1.7) | ||||
Post | 207 | 96.1 (92.5–98.3) | – | – | 217 | 98.2 (95.3–99.5) | ||
GMC (mIU/mL) | Pre | 206 | <150* | – | – | 220 | <150* | |
Post | 207 | 564.32 (511.88–622.13) | − | − | 217 | 572.09 (523.83–624.79) | ||
Anti-rubella | Seropositivity rate (concentration ≥ 4 IU/mL) | Pre | 206 | 2.4 (0.8–5.6) | − | − | 220 | 1.8 (0.5–4.6) |
Post | 207 | 99.5 (97.3–100.0) | – | – | 217 | 100.0 (98.3–100.0) | ||
GMC (IU/mL) | Pre | 206 | 2.08 (1.99–2.18) | – | – | 220 | 2.09 (1.98–2.20) | |
Post | 207 | 39.38 (35.20–44.06) | − | − | 217 | 42.45 (38.4246.92) | ||
Anti-YF | Seropositivity rate (Titre ≥ 10 ED50) | Post | 206 | 98.1 (95.1–99.5) | – | – | 216 | 98.6 (96.0–99.7) |
GMT (ED50) | Post | 206 | 318.93 (269.65–377.21) | 216 | 346.73 (296.62–405.30) |
The RTS,S coad group received the RTS,S/AS01 vaccines at 6, 7.5 and 9 months of age and the YF and MR vaccines at 9 months of age; the RTS,S alone group received the RTS,S/AS01 vaccines at 6, 7.5 and 9 months of age; and the Control group received the YF and MR vaccines at 9 months of age.
N, number of children with available results; CI, confidence interval; Anti-CS: antibodies to Plasmodium falciparum circumsporozoite (CS) protein; Anti-HBs: antibodies to hepatitis B surface antigen; Pre, pre-vaccination; Post, one month after the third dose of RTS,S/AS01 vaccine alone (RTS,S alone group), the third dose of RTS,S/AS01 vaccine given with YF and MR vaccines (RTS,S coad group) and the YF and MR vaccines (Control group); GMC, geometric mean concentration; HBs, hepatitis B surface antigens; YF, yellow fever; GMT, geometric mean titer; MR, combined measles-rubella. * Indicates that all children were seronegative and had a value below the cut-off of the assay.