RNA-Seq analysis of the TB-019 GSK M72/AS01E trial

This project involves RNA-Seq analysis of samples obtained from the Phase IIA clinical trial TB-019 (NCT01669096) which evaluated kinetics of response, safety, and immunogenicity of the GSK Mycobacterium tuberculosis (MTB) vaccine M72/AS01E (“GSK M72”). GSK M72 consists of the M72 recombinant fusion of Mycobacterium tuberculosis (MTB) proteins Rv0125 and Rv1196 in combination with the liposome, TLR4 ligand (MPL), and QS21 saponin adjuvant AS01E (Leroux-Roels et al., 2013). Overall design: This project involved sample collection from 18 according-to-protocol subjects that were vaccinated twice with 10µg M72/AS01E. Responses were measured at three time points in PBMC , with the majority of measurements being made early after the 2nd dose of the vaccine. The analyses will be performed on RNA samples collected from all eighteen subjects at the D0, D31, and D37 time points. Altogether, 54 samples were analyzed.