Grand Challenge #6-74 Biomarkers of Protective Immunity Against TB in the Context of HIV/AIDS in Africa
Information:
Sponsor - The Bill and Melinda Gates Foundation
Principal Investigator - Stefan H.E. Kaufmann, Ph.D., Max Planck Institute for Infection Biology; Co-Investigator - W. Henry Boom, M.D., CWRU
| Type of Study | Observational |
|---|---|
| Design | Longitudinal nested case-control cohort study with 2 year follow-up |
| Project Site | Uganda, The Gambia, Malawi, South Africa, Ethiopia |
| Sample Size | Total across sites: 1098 HIV- patients with active TB, 4690 household contacts and controls with and without LTBI, 359 HIV+ TB patients and 895 HIV+ household contacts and controls without TB |
| Population | Adults with a culture confirmed , initial case of clinically active tuberculosis and adult members of their households without TB disease |
| Study Period | 2006-2012 |
| Interactions | The TBRU enrolled subjects for the GC-6 studies through the Uganda-CWRU Research Collaboration. Additionally, the TBRU data coordinating center has managed the combined data from all participating field sites in Africa to produce a comprehensive database that can be used by GC6 researchers to develop and test hypotheses regarding the host response to TB infection and disease. |
Goal of Study:
The aim of this study is to learn which immunological responses provide protective immunity to TB in order to facilitate the discovery of new TB vaccines.
Objectives of Study:
- To compare biomarker responses between household contact participants that have natural immunity against active TB disease and household contact participants who progress to active disease within the 2 year follow-up time. Markers that differ between groups are potentially useful as correlates of protection
- To compare biomarker responses in HIV positive participants without active disease who control the infection compared to those HIV positive participants who progress to active disease over the 2 year follow-up and assess the effects of ART and treatment of latent infection on biomarker responses
Published Papers:
Black, GF, Thiel, BA, Ota, MO, Parida, SK, Adegbola, R, Boom, WH, Dockrell, HM, Kees, LMC, Friggen, AH, Hill, PC, Klein, MR, Lalor, MK, Mayanja, H, Schoolnik, G, Stanley, K, Weldingh, K, Kaufmann, SHE, Walzl, G, Ottenhoff, THM, and the GCGH Biomarkers for TB Consortium. Immunogenicity of Novel DosR Regulon-Encoded Candidate Antigens of Mycobacterium tuberculosis in Three High-Burden Populations in Africa. 2009. Clinical and Vaccine Immunology 16:1203-1212. PMID: 19553548