Table 1.
Demographic, serological and immunological characterization of the sub-study population at baseline visit. Differences between BM32-treated and placebo group are indicated. (* = p < .05 and n.s. = not significant). Baseline values for Phl p 1, Phl p 2, Phl p 5 and Phl p 6 specific IgE levels and T cell proliferation are displayed only for subjects sensitized to the relevant allergen.
|
Patient characteristics at baseline visit | ||||||||
|---|---|---|---|---|---|---|---|---|
|
Placebo (n = 10) |
BM32 (n = 25) |
|||||||
|
Sex |
Male | 4/10 (40%) | 13/25 (52%) | |||||
|
Female |
6/10 (60%) |
12/25 (48%) |
||||||
| Mean | Median | Range | Mean | Median | Range | p-value | ||
| Age | 27.3 | 24.8 | 21–45 | 27.3 | 26.0 | 19–46 | n.s. | |
| Proliferation (SI) | Recombinant mix-specific | 1.7 | 1.4 | 0.7–3.6 | 1.6 | 1.3 | 0.04–5.6 | n.s. |
| Phl p 1-specific | 1.3 | 1.3 | 0.7–22 | 1.4 | 1.3 | 0.7–2.7 | n.s. | |
| Phl p 2-specific | 1.1 | 1.1 | 0.5–1.9 | 1.2 | 1.2 | 0.6–2.1 | n.s. | |
| Phl p 5-specific | 1.1 | 1.0 | 0.7–1.9 | 1.3 | 1.3 | 0.6–2.3 | n.s. | |
| Phl p 6-specific | 1.4 | 1.3 | 0.4–3.7 | 1.3 | 1.1 | 0.6–2.8 | n.s. | |
| Pre S-specific | 0.04 | 0.03 | 0.01–0.16 | 0.40 | 0.04 | 0.01–5.1 | n.s. | |
| BM32-mix specific | 1.4 | 1.3 | 0.7–2.2 | 1.6 | 1.5 | 0.8–3.0 | n.s. | |
| Cytokines (pg/ml) in response to stimulation with a mix of Phl p 1, 2, 5, and 6 | IL-1 | 79.7 | 50.2 | 12.5–213.3 | 88.2 | 57.3 | 3.3–259.3 | n.s. |
| IL-2 | 58.8 | 20.9 | 8.4–368.5 | 38.9 | 18.0 | 0–245.2 | n.s. | |
| IL-4 | 3.6 | 3.1 | 0–7.8 | 4.1 | 3.1 | 0–13.9 | n.s. | |
| IL-5 | 34.7 | 34.4 | 13.2–57.7 | 33.7 | 34.0 | 7.6–66.2 | n.s. | |
| IL-6 | 583.1 | 521.0 | 104.1–1856.9 | 766.6 | 630.2 | 49.0–3672.0 | n.s. | |
| IL-7 | 14.6 | 0 | 0–145.9 | 0.9 | 0 | 0–9.7 | n.s. | |
| IL-10 | 139.8 | 7.7 | 0–1327.4 | 5.4 | 3.9 | 0–31.1 | n.s. | |
| IL-12 | 54.4 | 0 | 0–537.0 | 0.1 | 0 | 0–3.27 | n.s. | |
| IL-13 | 139.0 | 91.7 | 18.6–454.9 | 69.9 | 52.8 | 0–167.1 | n.s. | |
| IL-17 | 103.3 | 64.8 | 11.3–342.6 | 73.7 | 55.3 | 0–271.8 | n.s. | |
| GCSF | 363.2 | 146.7 | 63.9–1303.5 | 354.4 | 215.0 | 0–1534.5 | n.s. | |
| GMCSF | 47.5 | 26.1 | 8.6–197.1 | 30.7 | 24.2 | 0–117.4 | n.s. | |
| IFN-gamma | 245.8 | 265.2 | 110.2–387.0 | 211.0 | 159.8 | 24.2–468.3 | n.s. | |
| MCP | 2317.7 | 2227.2 | 755.4–3925.8 | 2204.1 | 2146.4 | 167.7–4023.4 | n.s. | |
| MIP-1 | 738.7 | 622.2 | 290.2–1913.3 | 880.1 | 950.2 | 68.1–2260.5 | n.s. | |
| TNF-alpha | 790.8 | 525.6 | 0–2226.0 | 1683.1 | 1217.0 | 61.0–6437.6 | n.s. | |
| IgE (kUA/L) | Total | 206.8 | 156.0 | 8.8–494.0 | 195.6 | 77.9 | 10.4–1035.0 | n.s. |
| Phl p 1-specific | 24.9 | 6.2 | 0.7–103.0 | 21.4 | 12.5 | 0.7–83.0 | n.s. | |
| Phl p 2-specific | 15.3 | 11.8 | 6.5–31.0 | 6.0 | 2.8 | 1.1–20.8 | n.s. | |
| Phl p 5-specific | 24.2 | 8.1 | 1.2–121.0 | 30.0 | 12.0 | 2.8–118.0 | n.s. | |
| Phl p 6-specific | 15.2 | 6.1 | 2.0–50.2 | 12.9 | 4.4 | 1.2–67.9 | n.s. | |
| IgG (OD405nm) | Phl p 1-specific | 0.4 | 0.3 | 0.2–0.6 | 0.4 | 0.3 | 0.1–0.6 | n.s. |
| Phl p 2-specific | 0.3 | 0.2 | 0.1–0.6 | 0.3 | 0.3 | 0.1–1.2 | n.s. | |
| Phl p 5-specific | 0.6 | 0.5 | 0.2–1.1 | 0.7 | 0.7 | 0.1–1.4 | n.s. | |
| Phl p 6-specific | 0.5 | 0.3 | 0.1–1.4 | 0.3 | 0.3 | 0.1–0.8 | n.s. | |
| IgG1 (OD405nm) | Phl p 1-specific | 0.02 | 0.02 | 0.01–0.03 | 0.02 | 0.01 | 0–0.07 | n.s. |
| Phl p 2-specific | 0 | 0 | 0–0.01 | 0.01 | 0 | 0–0.11 | n.s. | |
| Phl p 5-specific | 0.03 | 0.01 | 0–0.12 | 0.07 | 0.01 | 0–0.56 | n.s. | |
| Phl p 6-specific | 0.03 | 0.01 | 0–0.11 | 0 | 0 | 0–0.03 | n.s. | |
| IgG4 (OD405nm) | Phl p 1-specific | 0.02 | 0.01 | 0–0.05 | 0.02 | 0.01 | 0–0.09 | n.s. |
| Phl p 2-specific | 0 | 0 | 0–0.01 | 0.01 | 0 | 0–0.05 | n.s. | |
| Phl p 5-specific | 0.03 | 0.01 | 0–0.18 | 0.06 | 0.03 | 0–0.26 | n.s. | |
| Phl p 6-specific | 0 | 0 | 0–0.02 | 0 | 0 | 0–0.04 | n.s. | |