Number of cases of active TB (n = 710) per QFT result and time of diagnosis in relation to time of the QFT test.

<p>Number of cases of active TB (n = 710) per QFT result and time of diagnosis in relation to time of the QFT test.</p

Distribution of numerical QFT results from -2 to +2 IU/ml (1 n = 33225) where the range -0.05 to 0.04 IU/ml reaches outside the graph as the large number of observations in this range distorts the scale (n = 22645).

<p>Distribution of numerical QFT results from -2 to +2 IU/ml (1 n = 33225) where the range -0.05 to 0.04 IU/ml reaches outside the graph as the large number of observations in this range distorts the scale (n = 22645).</p

Categorical distribution of follow-up QFT results when retesting those with initial result in the borderline range (0.20–0.99 IU/ml).

<p>Categorical distribution of follow-up QFT results when retesting those with initial result in the borderline range (0.20–0.99 IU/ml).</p

Schematic outline of the analysis of proliferative responses and cytokine production by FASCIA and Luminex assay.

<p>Schematic outline of the analysis of proliferative responses and cytokine production by FASCIA and Luminex assay.</p

Cytokine results from multiplex analysis and proliferative responses from FASCIA after CFP-10 and ESAT-6 stimulation in patients with active-, latent- and non tuberculosis.

<p>Proportion of subjects with positive FASCIA is expressed as n/total for each group. Cut-off thresholds were set to gain 100% specificity for all assays. Each assay's sensitivity for active tuberculosis is calculated from these cut-offs. Sensitivity is shown for each antigen separate and when both are used in combination. Cytokine median results are presented in units of pg/ml and shown together with interquartile range (IQR). *IP-10 is significantly more sensitive than IFN-γ as a marker for active verified TB (p = 0.0233).</p

Significant median differences (MD), confidence intervals (CI) and P-values (p) for cytokine levels in active TB compared to controls and LTBI after stimulation with CFP-10 and ESAT-6.

<p>NS: non significant.</p

Correlation coefficients (CC) and confidence intervals (CI) with 95% confidence levels for the comparison of cellproliferation numbers and cytokine levels in patients with active TB.

<p>Correlation coefficients (CC) and confidence intervals (CI) with 95% confidence levels for the comparison of cellproliferation numbers and cytokine levels in patients with active TB.</p

Cytokine results from patients with verified active TB, after stimulation with CFP-10 (2 A) and ESAT-6 (2 B), in relation to cell proliferation.

<p>The data are presented as graphs with the number of lymphoblasts/μl on the X-axis and the level of cytokine production/cell (fg/cell) on the Y-axis. These graphs show lower levels of cytokines produced per cell, in strong responses, except for IFN-γ, where levels rise accordingly, although a few outliers influence ESAT-6 results for low levels of lymphoblasts/µl.</p

Heat maps: Cytokine levels in verified active TB patients divided by cut-off levels, after stimulation with CFP-10 (3 A) and ESAT-6 (3 B).

<p>The individual values are represented as colours. Light colours indicate high levels of cytokines and vice versa. On the Y-axis: The different cytokines tested with the FASCIA. On the X-axis: The cytokine levels, divided by the cut-off level for each cytokine, logged and sorted by rising proliferative responses (the higher the proliferative response, the further to the right).</p

Study Timeline and Sampling Schedule.

<p>NHPs were boosted with AERAS-402 fifteen and twenty-seven weeks after the prime with BCG or AFRO-1, Animals in group 1 were primed with BCG, animals in group 2 with the recombinant BCG (AFRO-1) which combines endosomal escape, TB10.4 expression and over-expression of Ag85A and Ag85B. Animals in both groups were boosted with the non-replicating adenovirus 35 AERAS-402 which expresses the Ag85A, Ag85B and TB10.4 fusion protein. Animals in group 3 received the diluent (control group).</p