A5302:  BioBank for Surrogate Marker Research for TB (B-SMART)

Study Location:

India

Topic:

Enrollment:

Closed

Trial Period:

Ongoing

Primary Objective

  • To obtain sputum, serum, urine, and peripheral blood mononuclear cells (PBMCs) for central TB biorepository storage from eligible participants undergoing treatment for culture-confirmed pulmonary TB.

Secondary Objectives

  • To evaluate the ability of the LitmusB (Vivione Biosciences), a novel flow cytometry assay that detects MTB in sputum, to differentiate viable from non-viable bacilli during the first 8 weeks of TB treatment.
  • To evaluate the host proteomic fingerprint in serum of persons with active TB, as defined by Next Generation Proteomics Liquid Chromatography-Mass Spectrometry (LC-MS) analysis and confirmed through multiplexed, high-throughput validated platforms (ie, bead-based immunoassays, aptamer arrays and electrochemiluminescence assays) as well as detection of MTB macromolecules carried on human “exosomes” - small, membrane-bound vesicles emitted from MTB-infected host cells found in the circulating blood of TB-infected participants.
  • To evaluate a host metabolomic fingerprint in urine from persons with active TB, identified by LC-MS in serial urine samples obtained during the first 8 weeks of TB treatment.
  • To identify and characterize host MTB-specific CD4+ and CD8+ T cell responses, as measured by interferon (IFN)-g ELISPOT(enzyme-linked immunosorbent spot),, using optimized antigens (peptide pools) in the intracellular cytokine staining (ICS) assay with improved sensitivity for detection of MTB, that are predictive of TB treatment failure.

Tertiary Objective

  • To collect PBMCs via BD CPT tubes; host peripheral mRNA via the PAXgene system; stimulated supernatant via the Quantiferon-Gold Intube system; and host DNA at select ACTG and TBTC sites that have the capacity and expertise to collect, process, and store such biospecimens for use in future TB biomarker research.

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