Table 1. Plasma cytokines after intradermal Nexvax2 or gluten challenge assessed with ECL assay.
Median, IQR values are shown. ND, not determined; NA, not applicable.
| #Patients (N) | Phase 1 trials of Nexvax2 i.d. in HLA-DQ2.5 CeD on GFD |
Sham-controlled food challenge in HLA-DQ2.5 CeD on GFD |
Open-food challenge muesli bar (5.7 g) in CeD on GFD |
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|
1st dose Nexvax2 All cohorts Any dose (60–300 μg) |
Nexvax2 150 μg 3-dose study |
Nexvax2 150 μg 16-dose study |
3-g gluten protein (vital wheat gluten flour slurry) |
Matched gluten- free challenge (rice flour slurry) |
All participants |
HLA- DQ2.5+ |
HLA-DQ8+ (−ve for HLA-DQ2.5) |
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| 1st dose |
3rd (final) dose |
1st dose |
16th (final) dose |
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| 54 | 8 | 8 | 15 | 15 | 11 | 8 | 19 | 16 | 3 | ||
| IL-2 | Baseline, pg/ml |
0.1 (0.1–0.2) | 0.2 (0.1–0.3) | 0.1 (0.1–0.3) | 0.1 (0.1–0.2) | 0.1 (0.1–0.2) | 0.1 (0.1–0.1) | 0.1 (0.1–0.2) | 0.1 (0.1–0.3) | 0.2 (0.1–0.3) | 0.1 (0.1–0.2) |
| Peak, pg/ml | 33 (1.3–92) | 40 (6.9–106) | 0.9 (0.5–2.0) | 53 (26–101) | 0.2 (0.1–0.2) | 1.8 (0.7–2.2) | 0.2 (0.1–0.2) | 1.0 (0.2–7.2) | 0.9 (0.2–4.2) | 8.0 (2.1–23) | |
| Peak, fold change |
272 (12–597) | 248 (34–707) | 8.4 (2.3–22) | 323 (131–915) | 1.0 (1.0–1.3) | 15 (5.3–27) | 1.0 (1.0–1.0) | 10 (1.8–27) | 7.3 (2.0–19) | 29 (8.4–246) | |
| Fisher’s exact, P value |
8.25E-08 | 1.55E-04 | 0.0070 | 5.86E-06 | 1.0 | 0.0001 | NA | 0.0006 | 0.0013 | 0.0545 | |
| Responder (%) |
96 | 100 | 75 | 100 | 0 | 91 | 0 | 74 | 75 | 67 | |
| Correlation with IL-8, r value |
0.84 | 0.98 | ND | 0.92 | ND | 0.81 | NA | 0.71 | 0.74 | 0.17 | |
| Correlation with IL-8, P value |
1.66E-15 | 3.25E-05 | ND | 1.23E-06 | ND | 0.0027 | NA | 0.0006 | 0.0011 | 0.8902 | |
| Correlation with IL-10, r value |
0.63 | ND | 0.98 | ND | 0.43 | 0.84 | NA | 0.96 | 0.99 | 0.85 | |
| Correlation with IL-10, P value |
5.80E-07 | ND | 1.30E-05 | ND | 0.1120 | 0.0013 | NA | 6.26E-11 | 2.64E-14 | 0.3532 | |
| IL-8 | Baseline, pg/ml |
4.0 (3.1–4.9) | 3.4 (2.9–5.0) | ND | 3.2 (2.5–3.8) | ND | 8.5 (7.2–12) | 5.8 (5.2–8.6) | 4.8 (3.5–5.5) | 4.9 (3.8–5.8) | 3.4 (2.1–4.6) |
| Peak, pg/ml | 43 (12–112) | 34 (27–76) | ND | 68 (35–168) | ND | 34 (12–46) | 6.5 (5.4–11) | 7.0 (5.0–18) | 7.0 (5.2–17) | 15 (5.7–28) | |
| Peak, fold change |
11 (2.7–31) | 12 (4.7–24) | ND | 13 (11–38) | ND | 2.4 (1.3–4.7) | 1.1 (1.0–1.2) | 1.5 (1.1–4.2) | 1.3 (1.1–3.3) | 4.5 (2.2–6.1) | |
| Fisher’s exact, P value |
1.15E-04 | 0.0014 | ND | 2.11E-04 | ND | 0.0128 | NA | 0.0258 | 0.0538 | 0.0545 | |
| Responder (%) |
78 | 88 | ND | 87 | ND | 64 | 0 | 47 | 44 | 67 | |
| IL-10 | Baseline, pg/ml |
6.1 (3.2–13) | ND | 0.3 (0.2–1.1) | ND | 0.2 (0.1–0.2) | 0.2 (0.2–0.6) | 0.3 (0.2–0.7) | 0.3 (0.2–0.3) | 0.3 (0.2–0.4) | 0.3 (0.2–0.3) |
| Peak, pg/ml | 15 (6.4–41) | ND | 2.3 (0.8–8.3) | ND | 0.2 (0.2–0.3) | 0.6 (0.4–0.7) | 0.3 (0.2–0.7) | 0.3 (0.3–0.7) | 0.3 (0.3–0.9) | 0.4 (0.2–0.4) | |
| Peak, fold change |
1.2 (1.0–3.4) | ND | 7.7 (1.9–28) | ND | 1.1 (1.0–1.3) | 1.5 (1.1–1.9) | 1.0 (1.0–1.0) | 1.2 (1.0–1.6) | 1.2 (1.0–2.3) | 1.2 (1.2–1.3) | |
| Fisher’s exact, P value |
0.0844 | ND | 0.0014 | ND | 0.5227 | 0.0445 | NA | 0.2855 | 0.2622 | 1.0 | |
| Responder (%) |
39 | ND | 88 | ND | 20 | 45 | 0 | 21 | 25 | 0 | |