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

Prime with BCG or AFRO-1 induces a different IFN-γ production profile in response to <i>Mtb</i> antigen stimulation.

<p>The median of IFN-γ production (measured by ELISA) in whole blood cultures for each group in response to different <i>Mtb</i> antigen stimulation was assessed. Stronger IFN-γ production was seen in animals primed with AFRO-1 in response to Ag85A and Ag85B, as compared to animals primed with BCG one week after the first boost with AERAS-402.</p

Prime with AFRO-1 induces proliferation of Ag85B-specific T cells in CD4⁺ and CD8alpha/alpha⁺ T cells.

<p>The median of the proliferation index (% of blasts in response to antigen stimulation - % of blasts in negative control) in response to <i>Mtb</i> antigens was determined by flow cytometric analysis. Differential expansion of T cell subsets was gauged by gating on T cell subsets, i.e. CD4⁺, CD8alpha/beta⁺ and CD8alpha/alpha⁺. Animals primed with AFRO-1 showed stronger proliferation in response to Ag85B stimulation within CD4⁺ T cells (A) and CD8alpha/alpha⁺ T cells (B) as compared to animals primed with BCG one week after the first boost with AERAS-402. No difference was detectable between animals primed with AFRO-1 or BCG in the CD8alpha/beta⁺ T cell compartment (C).</p