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.

Categories

Location
Topic

Clinical Trials

Identification of Biomarkers That Can Predict Progression...

Purpose: The C-TRIUMPH study has identified 20 household contacts (HHC), who have progressed to active TB from its HHCs cohort...

Read More

A5342: Evaluating the Safety, Tolerability, and Effect of a...

The purpose of this study is to evaluate the safety, tolerability, and effect of an experimental human monoclonal antibody...

Read More

P1073: Study of Immune Reconstitution Inflammatory Syndrome...

P1073 is a case controlled prospective, clinical, observational and pathogenesis study of HIV-infected infants and children...

Read More

A5300B/I2003B/PHOENIX, Protecting Households On Exposure to...

This study will compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing...

Read More

P2026: Pharmacokinetic Properties of Antiretroviral and...

IMPAACT P1026s, the predecessor of this study, was first approved in 2003. P1026s enrolled over 1000 pregnant/postpartum women,...

Read More