The clinical procedures, outcomes, and associated laboratory methods for the 3- and 16-dose randomized, double-blind, placebo-controlled, ascending dose phase 1 studies have been described in detail elsewhere (6). All participants provided written informed consent. Ethics committees gave approval for the three-dose study [Liberty Institutional Review Board (IRB) tracking number 12.07.0012, The University of Oklahoma Institutional Review Board for the Protection of Human Subjects IRB number 1370, Bellberry Human Research Ethics Committee application number 2013-10-553, and Southern Health and Disability Ethics Committee 13/STH/168] and for the 16-dose study (The Alfred Hospital Ethics Committee approval number 118/12, Bellberry Human Research Ethics Committee application number 2012-04-735-AA, Southern Health and Disability Ethics Committees ethics ref. NTY/12/06/049/AM05).

Stored plasma samples and clinical data were analyzed after the trials were completed and unblinding of data. Briefly, adult HLA-DQ2.5+ CeD patients on GFD were recruited at 12 sites in Australia, New Zealand, and the United States. During the screening period, patients evaluated for ascending dose cohorts had a 3-day gluten food challenge. Blood collected before and 6 days after commencing the gluten challenge were assessed in a whole-blood IFN-γ release assay, described in detail elsewhere (6). The last cohort in each study had a gastroscopy instead of a food challenge and was excluded if villous atrophy was present. Fixed doses of investigational product were administered by intradermal injection. Dose levels assessed were 60, 90, and 150 μg in the three-dose study and 150 and 300 μg in the 16-dose study. The matched placebo was 0.1 ml of sterile 0.9% sodium chloride. Timing and severity of adverse events were recorded. Gastrointestinal symptoms of pain, hunger pains, nausea, rumbling, bloating, and diarrhea were assessed daily by patients using a seven-point graded Likert scale, where one represented the most positive option, and seven represented the most negative one in the format of the Gastrointestinal Symptom Rating Scale. Blood for plasma cytokine assessment was collected into K2 EDTA Vacutainer tubes (Becton Dickinson, Franklin Lakes, NJ), which were centrifuged within 10 min of collection at 1100 to 1300 RCF (relative centrifugal force) for 10 min, and then, plasma was stored at or below −60°C. Cytokines were assessed in plasma from blood collected within 30 min before (baseline) and at 10, 20, 30, and 45 min and 1, 1.5, 2, 4, and 6 hours after dosing on the first day. Plasma over the same time course was also assessed in patients after their last dose for those in cohorts receiving the maximum tolerated dose of Nexvax2 (150 μg).

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