Large Scale Antibody and T-cell Epitope Discovery Program

Information:

Sponsor - U.S. National Institutes of Health (HHSN272200900053C)
Principal Investigator - David Lewinsohn, M.D., Oregon Health and Sciences University

ADULT SUB-STUDY: CD8+ T Cell Responses in Latent TB Infection and Pulmonary TB in HIV Infected 
and Un-infected Ugandan Adults (AC80)

DMID Protocol Number: 10-0042

Type of Study Observational
Design Cross-Sectional w/2 month follow-up
Project Site Uganda
Sample Size 385 active TB/HIV-; up to 385 latent TB/HIV-; 55 active TB/HIV+
Population Adults with a culture confirmed , initial case of clinically active tuberculosis or latent TB infection
Study Period September 2011 - 2014

Hypothesis:

Detection of novel CD8+ T cell receptors directed towards MTB antigens may distinguish LTBI from pulmonary TB.

Objectives:

  1. To determine novel epitopes/antigens common and dominant in MTB-infected Uganda adults with LTBI and PTB.
  2. To determine epitopes/antigens associated specifically with pulmonary TB versus LTBI.
  3. To determine epitopes/antigens associated with pulmonary TB in HIV infected Uganda adults (CD4 T cell count >150).

PEDIATRIC SUB-STUDY: Novel Cd8+ T Cell Diagnostics For Childhood Tuberculosis (PC08)

DMID Protocol Number: 09-0109

Type of Study Observational
Design Cross-Sectional
Project Site Uganda
Sample Size Proposed 92 subjects with intrathoracic TB HIV uninfected, 18-19 subjects with intrathoracic TB HIV infected and 50 subjects with LRTI not due to TB HIV uninfected, final enrollment was 323
Population Hospitalized Ugandan children greater than 2 months and less than 5 years of age
Study Period Nov 2011 - 2014

Goal of Study:

Our goal is to answer: Is detection of CD8+ T cells directed towards Mtb proteins can be utilized to distinguish young children with intrathoracic TB from those with pneumonia or lower respiratory infection (LRTI) from etiologies other than TB?

To do this, we have designed a cross sectional, observational study to define the presence and magnitude of a CD8+ T cells responses among these distinct clinical groups (intrathoracic TB vs. pneumonia or LRTI not TB).

Objectives of Study:

  1. To determine if measurement of CD8+ T cells specific for two-Mtb antigen combinations distinguishes between intrathoracic TB and LRTI not due to TB (LRTInotTB) in children less than 5 years old.
  2. To determine if measurement of CD8+ T cells specific for three-Mtb antigens distinguishes between intrathoracic TB and LRTInotTB in children less than 5 years old.
  3. To determine if measurement of CD8+ T cells specific for Mtb antigens distinguishes between intrathoracic TB (HIV infected and uninfected) and LRTInotTB (HIV uninfected) in children less than 5 years old.