Transcriptional signatures to AS01-adjuvanted tuberculosis vaccine in naïve and primed participants

In this exploratory post-hoc analysis of clinical trial samples (clinicalTrials.gov: NCT01424501), we compared gene expression patterns elicited by two immunizations with the candidate tuberculosis (TB) vaccine M72/AS01, between three groups of individuals with different levels of memory responses to TB antigens before vaccination There were a total of 239 samples from 64 subjects across 3 time points (D0, D7, D37). Subjects were distributed in 3 groups, TB disease naïve PPD negative (TBDN -NEG), TB disease naïve PPD positive (TBDN -POS), and TB experienced individuals (TB-TRT). A third, incompletely recruited cohort of subjects receiving treatment for active TB was not analyzed due to its small sample size (ACTIVETB_TRT). Per-protocol immunization was at Day (D)0 and D30, and all but three of these participants received two vaccine doses.