This contract will establish and support the Tuberculosis Research Unit (TBRU), a multi-disciplinary, multi-national consortium of investigators and institutions with expertise in the areas of epidemiology, microbiology, and immunity, to conduct clinical studies on host-pathogen interactions in tuberculosis (TB). The overall goal of the clinical studies to be carried out by the TBRU is to fill critical gaps in translational TB research and to provide tools needed to advance new health care interventions in TB endemic countries.

The TBRU must include:

1. At least one country outside of the United States (U.S.) in which TB is endemic and foreign clinical sites with an established infrastructure capable of conducting the clinical studies, including local investigators experienced in the conduct of multi-disciplinary human clinical studies in TB, laboratory facilities and personnel to perform protocol-specific tests, and access to relevant patient populations;.


2. A Data Management Center for the collection, storage, quality control, and evaluation of all data derived from the clinical studies; and


3. A Specimen Repository for the storage and inventory of mycobacterial strains and human-derived materials.
   

SCOPE

1. The Contractor shall design, conduct and direct clinical studies in human TB to establish markers to:
   1. identify individuals at highest risk for progression to TB disease after infection with Mycobacterium tuberculosis (Mtb);
      
   2. characterize correlates of response to therapy and vaccination that can establish useful early estimates of clinical efficacy of new health care interventions; and
      
   3. eventually contribute to the identification of new diagnostic tests and improved therapeutic and vaccination strategies.


2. A Data Management Center for the collection, storage, quality control, and evaluation of all data derived from the clinical studies; andThe resources/studies to be provided under this contract shall be performed either directly by the Contractor or indirectly through subcontractors. At a minimum, the Contractor shall:
   1. Establish and direct the TBRU consortium. b
   2. Develop the overall Clinical Study Plan, including proposed studies and timelines for completion.
   3. Provide an infrastructure for the overall scientific, technical and administrative management of the clinical studies.
   4. Provide clinical study oversight for all clinical sites and studies.
   5. Establish and direct the projects and activities of the Specimen Repository of clinical samples.
   6. Establish and direct the projects and activities of the Data Management Center.
   7. Solicit for and evaluate the technical merit and proposed costs for additional clinical sites that should need to be added during the contract, execute and manage studies at these sites, and assess subcontractor performance.
   8. Provide for an orderly transition to a successor contractor or to the Government at the end of the contract period of performance.