Table 2.
Percentages of subjects responding to the vaccines
| Increase in M72-specific CD4+ T-cell frequencies over pre-vaccinationa | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Time-point | Group | N | 2-fold | 4-fold | 6-fold | 8-fold | ||||
| % | [95 % CI] | % | [95 % CI] | % | [95 % CI] | % | [95 % CI] | |||
| Day 30 | M72/AS02D (10 μg) | 34 | 91.2 | [76.3–98.1] | 70.6 | [52.5–84.9] | 52.9 | [35.1–70.2] | 47.1 | [29.8–64.9] |
| M72/AS01E (10 μg) | 38 | 97.4 | [86.2–99.9] | 81.6 | [65.7–92.3] | 71.1 | [54.1–84.6] | 57.9 | [40.8–73.7] | |
| M72/AS01E (20 μg) | 39 | 97.4 | [86.5–99.9] | 82.0 | [66.5–92.5] | 74.4 | [57.9–87.0] | 66.7 | [49.8–80.9] | |
| M72/AS01B (40 μg) | 37 | 100.0 | [90.5–100.0] | 91.9 | [78.1–98.3] | 81.1 | [64.8–92.0] | 67.6 | [50.2–82.0] | |
| M72/Saline (40 μg) | 9 | 66.7 | [29.9–92.5] | 33.3 | [7.5–70.1] | 11.1 | [0.3–48.2] | 11.1 | [0.3–48.2] | |
| AS01B | 9 | 33.3 | [7.5–70.1] | 22.2 | [2.8–60.0] | 22.2 | [2.8–60.0] | 22.2 | [2.8–60.0] | |
| Day 60 | M72/AS02D (10 μg) | 34 | 94.1 | [80.3–99.3] | 88.2 | [72.5–96.7] | 76.5 | [58.8–89.3] | 64.7 | [46.5–80.3] |
| M72/AS01E (10 μg) | 38 | 100.0 | [90.7–100.0] | 94.7 | [82.2–99.4] | 89.5 | [75.2–97.1] | 86.8 | [71.9–95.6] | |
| M72/AS01E (20 μg) | 38 | 100.0 | [90.7–100.0] | 94.7 | [82.2–99.4] | 78.9 | [62.7–90.4] | 65.8 | [48.6–80.4] | |
| M72/AS01B (40 μg) | 37 | 97.3 | [85.8–99.9] | 91.9 | [78.1–98.3] | 86.5 | [71.2–95.5] | 81.1 | [64.8–92.0] | |
| M72/Saline (40 μg) | 9 | 88.9 | [51.7–99.7] | 22.2 | [2.8–60.0] | 11.1 | [0.3–48.2] | 11.1 | [0.3–48.2] | |
| AS01B | 9 | 11.1 | [0.3–48.2] | 0.0 | [0.0–33.6] | 0.0 | [0.0–33.6] | 0.0 | [0.0–33.6] | |
| Day 210 | M72/AS02D (10 μg) | 30 | 93.3 | [77.9–99.2] | 70.0 | [50.6–85.3] | 60.0 | [40.6–77.3] | 56.7 | [37.4–74.5] |
| M72/AS01E (10 μg) | 37 | 94.6 | [81.8–99.3] | 94.6 | [81.8–99.3] | 89.2 | [74.6–97.0] | 75.7 | [58.8–88.2] | |
| M72/AS01E (20 μg) | 35 | 100.0 | [90.0–100.0] | 82.9 | [66.4–93.4] | 65.7 | [47.8–80.9] | 57.1 | [39.4–73.7] | |
| M72/AS01B (40 μg) | 34 | 97.1 | [84.7–99.9] | 94.1 | [80.3–99.3] | 79.4 | [62.1–91.3] | 70.6 | [52.5–84.9] | |
| M72/Saline (40 μg) | 7 | 71.4 | [29.0–96.3] | 28.6 | [3.7–71.0] | 0.0 | [0.0–41.0] | 0.0 | [0.0–41.0] | |
| AS01B | 8 | 25.0 | [3.2–65.1] | 25.0 | [3.2–65.1] | 25.0 | [3.2–65.1] | 25.0 | [3.2–65.1] | |
aA subject was considered a responder to the vaccine if the frequency of CD4+ T cells expressing at least two markers (among CD40L, IL-2, TNF-α and IFN-γ) after vaccination was at least 2-fold, at least 4-fold, at least 6-fold or at least 8-fold higher than the frequency of these cells at pre-vaccination (as measured in the same subject). N number of subjects with available results, CI 95 % confidence interval