Table 1. Baseline characteristics of study participants.
| (Phase 1b Trial) | Follow-up | ||||||||||
| Study | Stage 1 | Stage 2 | (additional control group) | ||||||||
| Age cohort (years) | 21–40 | 16–20 | 11–15 | 6–10 | 16–20 | 11–15 | 6–10 | ||||
| Vaccine | BK-SE36 | Saline | BK-SE36 | Saline | BK-SE36 | Saline | BK-SE36 | Saline | (None) | (None) | (None) |
| Age (y) | 22.2 (1.16) | 22.8 (2.49) | 17.86 (0.99) | 18.33 (1.03) | 12.8 (1.38) | 12.3 (0.52) | 8.2 (1.44) | 7.7 (1.86) | 17.82 (1.13) | 12.94 (1.34) | 8.38 (1.5) |
| [Min–Max] | [21]–[24] | [21–32] | [16]–[20] | [17]–[20] | [11]–[15] | [12]–[13] | [6]–[10] | [6]–[10] | [16]–[20] | [11]–[15] | [6]–[10] |
| Height (cm) | 168.6 (7.25) | 166.4 (6.06) | 168.5 (7.43) | 165.4 (5.75) | 154.7 (7.42) | 149.1 (6.45) | 132.7 (9.76) | 130.6 (11.6) | 165.1 (7.32) | 156.0 (10.86) | 130.8 (9.14) |
| [Min–Max] | [153.7–184.3] | [157.0–183.0] | [157.0–182.2] | [160.0–172.5] | [140.0–169.7] | [140.0–160.0] | [110.5–153.0] | [116.7–147.4] | [150.7–175.0] | [136.5–178.3] | [115.6–148.5] |
| Weight (kg) | 61.8 (7.06) | 59.98 (7.49) | 58.32 (3.96) | 55.85 (5.17) | 44.06 (8.46) | 39.97 (5.40) | 28.4 (5.60) | 28.25 (6.18) | 54.79 (6.25) | 43.34 (8.59) | 27.96 (6.47) |
| [Min–Max] | [48.2–74.8] | [48.5–75.5] | [50.0–67.0] | [49.0–61.0] | [34.0–63.0] | [33.5–47.5] | [17.0–42.0] | [20.5–38.0] | [42.0–63.0] | [29.5–56.9] | [19.0–41.0] |
| BMI | 21.7 (2.11) | 21.68 (2.58) | 20.65 (1.94) | 20.43 (1.91) | 18.31 (2.45) | 18.02 (2.28) | 15.95 (1.4) | 16.45 (1.95) | 20.20 (1.78) | 17.64 (1.88) | 16.18 (2.33) |
| [Min–Max] | [17.8–25.7] | [18.1–28.0] | [18.1–25.0] | [18.3–23.8] | [15.4–24.2] | [15.5–20.7] | [13.9–19.8] | [14.3–18.9] | [18.1–23.7] | [14.5–21.8] | [14.2–22.5] |
| Parasite positive | 2/36 | 1/20 | 2/22 | 1/6 | 7/22 | 3/6 | 4/22 | 2/6 | 4/17 | 5/17 | 6/16 |
| (n/N) | |||||||||||
| Anti-SE36 titer (GM) | 114.65 | 101.34 | 149.7 | 163.90 | 79.66 | 90.57 | 25.62 | 51.98 | 121.21 | 76.28 | 14.27 |
| (95% CI) | (65.98; 199.24) | (49.71; 206.63) | (75.4; 296.9) | (41.05; 654.5) | (49.62; 127.9) | (18.02; 455.2) | (14.49; 45.31) | (23.26; 116.2) | (55.39; 265.3) | (31.71; 183.5) | (7.71; 26.43) |
BMI, body mass index; Table shows the mean characteristics (SD) of the subjects during screening. For P. falciparum infection values, n = no. of subjects/N = total subjects enrolled and randomized. Those who were blood smear positive were treated. Only those who were blood smear negative were vaccinated. Anti-SE36 titers are reflected as geometric mean titers (GM: 95% CI, confidence interval).