Table 3.

Whole blood interferon-γ release assay (IGRA) with Nexvax2 peptides after post-treatment gluten challenge by post hoc analysis

Study	3-dose study				16-dose study
Cohort/s Treatment	1st, 2nd & 3rd Placebo	1st Nexvax 2 60 µg	2nd Nexvax2 90 µg	3rd Nexvax2 150 µg	1st & 2nd Placebo	1st Nexvax2 150 µg	2nd Nexvax2 300 µg
Participants randomized	(n=11)	(n=9)	(n=9)	(n=8)	(n=7)	(n=8)	(n=10)
Participants commenced post-treatment OGC	11 (100%)	8 (89%)	8 (89%)	8 (100%)	7 (100%)	8 (100%)	2 (20%)
Participants completed post-treatment OGC	7 (78%)	6 (67%)	8 (89%)	7 (88%)	3 (43%)	8 (100%)	2 (20%)
Participants eligible for PD analysis*	9 (82%)	6 (67%)	8 (89%)	6 (75%)	5 (71%)	8 (100%)	2 (20%)
Responders of participants eligible for analysis	7 (78%)	4 (67%)	3 (38%)	0 (0%)	5 (100%)	2 (25%)	0 (0%)
P-value#	NA	1	0·1534	0·007	NA	0·021	0·0476

^*Participants who did not finish all study doses, or post-treatment gluten challenge were not included in analysis. IGRA responders were Nexvax2-specific IGRA positive 6 or 8 days after commencing gluten challenge, and “non-responders” were Nexvax2-specific IGRA negative 6 or 8 days after commencing OGC when all 9 gluten cookies had been consumed (Algorithm outlined in Figures S3).

^#P-value was estimated by Two-tailed Fisher's Exact Test comparing treatment with placebo