Stellenbosch University Immunology Research Group
Collaboration with researchers at the University of Texas and Texas Biomedical Research Institute to evaluate immune-endocrine dysregulation in Type 2 Diabetes and its impact on immune responses to Mtb in peripheral blood and the lung.
The Correlate of Risk Targeted Intervention Study (CORTIS) is a randomized, partially-blinded, clinical trial of Isoniazid and Rifapentine (3HP) therapy to prevent pulmonary Tuberculosis in high-risk individuals identified by a transcriptomic correlate of risk. SU-IRG is one of 5 trials sites; the sponsor is UCT SATVI.
The validation of correlates of risk of TB disease in high-risk populations (CORTIS-HR) is a companion study of the CORTIS-01 trial that looks at whether the prognostic correlate of risk (COR) status differentiates HIV infected persons with cumulative prevalent or incident TB disease from those without TB disease. This is also a multi-site South African study sponsored by UCT SATVI.
This clinical trial uses biomarkers to Predict TB treatment duration. The primary aim of the study is to demonstrate that the 18-month treatment success rate of standard treatment stopped early at week 16 (Arm C) is not inferior to standard treatment stopped at week 24 (Arm B), in participants classified as low risk for disease failure and relapse by radiographic and bacterial load markers. This is a multi-country, multi-site trial, sponsored by SU-IRG.
A 5349 / Study 31 is a Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: a randomized, open-label, controlled, phase 3 clinical trial. This is a global clinical trial sponsored jointly by the ACTG and the TBTC. SU-IRG is performing the clinical duties within this trial in collaboration with FAMCRU/KidCRU, which is one of the study sites.
This observational study is an evaluation of host biomarker-based point-of-care tests for targeted screening for active TB. This diagnostic study developed from the AETBC study, aims to test the accuracy, sensitivity and specificity of the TransDot finger-prick test when compared with the composite gold standard tests. It is a multi-site South African study, sponsored by SU-IRG.
The NexGen EBA aims to use Radiologic and immunologic biomarkers to enhance early bactericidal activity measurements of sterilizing drug activity in tuberculosis.
RePORT / CORdynamics
This is a sub-study of The Correlate of Risk Targeted Intervention Study (CORTIS) and the PredictTB clinical trials, and aims to evaluate the dynamics of a qRT-PCR based transcriptomic signature of TB disease risk.
Trials of Excellence in Southern Africa (TESA) is a regional network established in 2009, funded by the European and Developing Countries Clinical trials Partnerships (EDCTP), with the objectives to create a framework for collaboration, capacity building and training among institutions from Southern African countries. TESA II aims to develop, strengthen and expand clinical research capacities in the Southern Region of Africa, through the consolidation of the TESA node of excellence, for conducting clinical trials with the highest research standards in those infectious diseases responsible for the highest morbidity and mortality in the region.
A multinational collaboration on a large cohort of TB patients and their household contacts for discovery of biomarkers of Mtb infection and disease. https://www.ncbi.nlm.nih.gov/pubmed/27017310
A 4 year multinational collaboration focused on unravelling the causal link
between active TB disease and Type 2 Diabetes Mellitus. It utilizes
bi-directional screening – that is screening TB patients for Diabetes and
screening Diabetes patients for Mtb to investigate interactions between these
A multinational collaboration focusing on immune and metabolic responses to TB
treatment, to discover signatures that distinguish between fast and slow
responders, as well as treatment failures and relapsers.
MRC SHIP / SATBBI
A South African initiative for the discovery and refinement of biomarkers and to promote Mtb biomarker bioinformatics.
Multinational collaboration to identify correlates of (vaccine-induced) protection for active TB.
Collaboration in a Phase IIb trial to assess immunogenicity and safety of the VPM1002 BCG replacement vaccine in newborns.
This was an African-European collaboration for discovering new, cost-effective point-of-care diagnostic tests for tuberculosis.
A three year study in collaboration with the Catalysis Foundation, to identify biomarkers that correspond to a patient's active TB load for diagnosis and treatment response. This project has been completed.
A study in collaboration with BECTON DICKINSON AND COMPANY analysed blood samples from patients on TB treatment, to identify the regulation of several surface markers expressed on peripheral blood cells by BD FACSCAP technology flow cytometry.
P1041 was a Phase II/III randomized, double-blind, placebo-controlled
clinical research study of African infants exposed perinatally to
HIV. The study was designed to determine the efficacy of isoniazid (INH)
in preventing tuberculosis disease and latent tuberculosis infection.
Study of Immune
Reconstitution Inflammatory Syndrome (IRIS) for International Sites
Initiating Highly Active Antiretroviral Therapy (HAART) in Infants and
Children < 72 Months of Age.