Stellenbosch University Immunology Research Group
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 study aims to investigate the immune mechanism of protection against Myb by characterizing the immune landscape in the lung and draining lymph nodes associated with the capacity to eradicate or control a subsequent Mtb challenge.
MR1 Lung Resident
This study aims to investigate MR1-Restricted T Cells and ssociation with differential outcomes following exposure to Mtb by defining the prevalence and effector function of MR1T cells in the lung and peripheral blood in the setting of exposure to Mtb and HIV.
This study aims to investigate the memory phenotype and function of TB-reactive human MR1 restricted cells by determining whether or not CD8+ MR1T cells have features of immunological memory.
MRC SHIP / SATBBI
A South African initiative for the discovery and refinement of biomarkers and to promote Mtb biomarker bioinformatics.
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.
This clinical trial is a multicenter, phase III, double-blind, randomized, active-controlled study to evaluate the efficacy and safety of VPM1002 in comparison to BCG in prevention of Mycobacterium tuberculosis infection in newborn infants.
This study aims to collect and store high quality and well-characterized specimens (sputum, serum, plasma, urine) from a geographically diverse population of participants with symptoms suggestive of TB and to encourage and accelerate the development of novel, appropriate TB diagnostics.
This study aims to finalise a POC-MBT TB triage test suitable for global application and to perform field-testing and validation thereof. The target for each validation process will be the World Health Organisation (WHO) target product profile 90% sensitivity and 70% specificity..
This was an African-European collaboration for discovering new, cost-effective point-of-care diagnostic tests for tuberculosis.
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.
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 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.
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.
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.
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.
multinational collaboration on a large cohort of TB patients and their
household contacts for discovery of biomarkers of Mtb infection and
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.
NexGen EBA aims to use Radiologic and immunologic biomarkers to enhance
early bactericidal activity measurements of sterilizing drug activity
RePORT / CORdynamics
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.
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.
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
Multinational collaboration to identify correlates of (vaccine-induced) protection for active TB.
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.
Collaboration in a Phase IIb trial to assess immunogenicity and safety of the VPM1002 BCG replacement vaccine in newborns.