TABLE 1.
Group (n) | Incidence of symptomb
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Skin redness
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Skin swelling
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Muscle induration
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Preinjection | Dose 1 | Dose 2 | Dose 3 | Preinjection | Dose 1 | Dose 2 | Dose 3 | Preinjection | Dose 1 | Dose 2 | Dose 3 | |
Control (5) | 0.60 ± 0.25 | 0.80 ± 0.37 | 0.80 ± 0.20 | 0.80 ± 0.20 | 0.20 ± 0.20 | 0.20 ± 0.20 | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.20 ± 0.20 | 0.12 ± 0.20 | 1.00 ± 0.32 | 0.20 ± 0.20 |
LSA1/AS01B (8) | 0.25 ± 0.25 | 1.25 ± 0.31 | 0.63 ± 0.26 | 0.38 ± 0.26 | 0.13 ± 0.13 | 1.38 ± 0.26 | 0.63 ± 0.26 | 0.13 ± 0.13 | 0.00 ± 0.00 | 2.38 ± 0.18 | 1.88 ± 0.30 | 1.00 ± 0.27 |
RTS,S/AS01B (8) | 0.38 ± 0.26 | 1.25 ± 0.31 | 0.88 ± 0.30 | 0.50 ± 0.19 | 0.25 ± 0.25 | 1.00 ± 0.38 | 0.75 ± 0.49 | 0.38 ± 0.38 | 0.00 ± 0.00 | 2.38 ± 0.18 | 2.00 ± 0.27 | 1.25 ± 0.31 |
LSA1/AS01B plus RTS,S/AS01B | ||||||||||||
LSA1 leg (8) | 0.38 ± 0.18 | 1.13 ± 0.23 | 0.88 ± 0.30 | 0.63 ± 0.26 | 0.00 ± 0.00 | 1.38 ± 0.53 | 1.13 ± 0.44 | 0.13 ± 0.13 | 0.25 ± 0.16 | 2.63 ± 0.18 | 2.75 ± 0.16 | 2.00 ± 0.19 |
RTS,S leg (8) | 0.38 ± 0.18 | 1.00 ± 0.27 | 0.88 ± 0.30 | 0.63 ± 0.26 | 0.00 ± 0.00 | 1.00 ± 0.38 | 1.13 ± 0.44 | 0.38 ± 0.26 | 0.00 ± 0.00 | 2.25 ± 0.31 | 2.38 ± 0.26 | 1.38 ± 0.18 |
Grade 3 muscle induration was frequently observed on days 1 and 2 after the third dose of vaccine. This subsided on day 3 and disappeared on day 14.
Data are mean intensities ± SE for scores ranging from 0 to 3 (0, absent; 1, mild; 2, moderate; and 3, severe).