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 GFDSham-controlled food
challenge in HLA-DQ2.5
CeD on GFD
Open-food challenge muesli bar (5.7 g) in
CeD on GFD
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)
1st dose3rd
(final)
dose
1st dose16th
(final)
dose
5488151511819163
IL-2Baseline,
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/ml33 (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-081.55E-040.00705.86E-061.00.0001NA0.00060.00130.0545
Responder
(%)
96100751000910747567
Correlation
with IL-8,
r value
0.840.98ND0.92ND0.81NA0.710.740.17
Correlation
with IL-8,
P value
1.66E-153.25E-05ND1.23E-06ND0.0027NA0.00060.00110.8902
Correlation
with
IL-10, r
value
0.63ND0.98ND0.430.84NA0.960.990.85
Correlation
with
IL-10, P
value
5.80E-07ND1.30E-05ND0.11200.0013NA6.26E-112.64E-140.3532
IL-8Baseline,
pg/ml
4.0 (3.1–4.9)3.4 (2.9–5.0)ND3.2 (2.5–3.8)ND8.5 (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/ml43 (12–112)34 (27–76)ND68 (35–168)ND34 (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)ND13 (11–38)ND2.4 (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-040.0014ND2.11E-04ND0.0128NA0.02580.05380.0545
Responder
(%)
7888ND87ND640474467
IL-10Baseline,
pg/ml
6.1 (3.2–13)ND0.3 (0.2–1.1)ND0.2 (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/ml15 (6.4–41)ND2.3 (0.8–8.3)ND0.2 (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)ND7.7 (1.9–28)ND1.1 (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
0.0844ND0.0014ND0.52270.0445NA0.28550.26221.0
Responder
(%)
39ND88ND2045021250