Total CD4+ T cell cytokine positive production by DAR-901, BCG and placebo vaccinated individuals in response to Mtb lysate stimulation at various study timepoints.

CD4+ T cell expression of IFNγ (a), IL2 (b), TNFα (c), IL17(d), IL22 (e) and any IFNγ+, IL2+,TNFα+ cytokine (f) and any IFNγ+, IL2+,IL17+,IL22+ cytokine (g) in response to Mtb lysate stimulant in the DAR-901 (n = 10), BCG (n = 9) and Placebo (n = 9) vaccinated subject was assessed. The median CD4+ T cell cytokine responses (+IQR) are shown at each visit, after subtraction of the unstimulated levels. Treatment-specific immune responses were calculated by AUC analyses for the longitudinal immune responses for individual participants within each treatment group. The Kruskal-Wallis test (with Dunn’s post hoc test) was used to assess for differences between groups from 7-days until 180-days post dose 3 in total cytokine-producing CD4+ T cells (results shown above). Total median cytokine producing CD4+ T cell responses were compared for differences at baseline, at 7-days post dose 3 and at 180-days post dose 3) using Wilcoxon signed-rank test (results shown in S1 Table).