PredictTB is a global approach by partners from Africa, Asia, Europe and the United States to identify biomarkers indicating treatment response and to ultimately significantly shorten TB treatment in the majority of TB patients worldwide.

Consortium

Five local partner sites in Cape Town (Stellenbosch University, two sites at University of Cape Town, the University of Cape Town Lung Institute, and TASK Foundation) will be enrolling and following-up 420 patients with drug sensitive pulmonary TB, and will contribute to data analysis.

In the clinical trial, participants will receive HRZE for 8 weeks, followed by discontinuation of PZA and ethambutol. Those who meet early treatment completion criteria will be randomized at Week 16 either to continue therapy for the standard duration or to complete early at week 16, whereas failure to meet early completion criteria will continue on the standard regimen. All subjects will be followed until 72 weeks with the primary endpoint evaluated at 18 months.

  • Stellenbosch University Immunology Research Group
    Short Profile

    The Immunology Research Group of the Division of Molecular Biology and Human Genetics, Faculty of Health Sciences, Stellenbosch University has extensive experience in TB research. The faculty is linked to Tygerberg Academic Hospital, a 1400 bed hospital, which provides secondary and tertiary healthcare to two million people from the Western Cape in South Africa and serves as a teaching platform and research base for the University of Stellenbosch.

    SUN focuses on the immunology of Mycobacterium tuberculosis (MTB) infection and ,in particular, host biomarkers. Prof. Walzl and his team work in close collaboration with the microbiologists in their department, whose focus is the molecular epidemiology of the TB epidemic, as well as epidemiologists who have developed paediatric and adult research sites in and around Cape Town.

    SUN‘s laboratories allow access to a wide range of molecular and cellular immunology techniques.

    Role in the Project
    • Stellenbosch University is the South African National and Local PI site of the study.
    • Stellenbosch will be involved in Screening and Enrolment with their Clinical Team as well as sample processing in the Immunology Laboratory.
    • SU-IRG are the lead site for the planning of collection of samples for TB Biomarker discovery.
    • SU-IRG supports multiple student projects for those obtaining Master’s and Doctoral degrees from Stellenbosch University.
    • SU-IRG are the lead site for the PET/CT Scanning of participants at Tygerberg Hospital PET/CT Centre.
    Main Contact Person
    Photo of Gerhard Walzl
    Prof. Gerhard Walzl
    Phone: +27 21 938 9401
    Links
  • South African Tuberculosis Vaccine Initiative
    Short Profile

    The mission of SATVI is the development of new and effective vaccination strategies against tuberculosis with the potential to save hundreds of thousands of lives world-wide. We are testing multiple new vaccine candidates in clinical trials. We are also completing projects to address critical clinical, epidemiological, immunological and human genetic questions in TB vaccine development as well as taking part diagnostic and drug trials. The SATVI field site is located 110km outside Cape Town, where the rate of TB is amongst the highest recorded in the world.

    SATVI regards each of its >100 personnel members as critical for it’s success. Our team consists of specialists in: administration, clinical, epidemiological, human genetic and immunologic science, clinical trials, community liaison, recruitment and follow-up; data management and analysis, disease surveillance, information technology, clinical evaluation and care of participants,; facility management, laboratory technology, logistics, research pharmacy management, project management, regulatory affairs, study coordination and training.

    Role in the Project
    • Recruitment, enrolment and follow up of participants
    • Processing and storage of immunology samples (WBA)
    • Protocol development
    • Reporting of results
    Main Contact Person
    Photo of Michele Tameris
    Dr Michele Tameris
    Phone: +27 23 346 5400
    Links
  • Wellcome Centre for Infectious Diseases Research in Africa
    Short Profile

    CIDRI-Africa conducts high-quality translational infectious disease research in a setting of tremendous disease burden. The juxtaposition of infection burden with sophisticated research laboratories offers unique advantage.

    We foster investigator-led approaches via an overarching scientific theme:

    1. To combat infection, especially HIV-1 and tuberculosis, via clinical and laboratory research

    Specific subthemes within this are:

    2. To understand overlap between infections and non-communicable diseases of poverty, especially where the latter impact susceptibility to, or arise as a consequence of, infection

    3. To understand and tackle the challenges (e.g. metabolic complications, resistance) of large-scale antiretroviral therapy.

    Role in the Project
    • Clinical recruitment of participants at Khayelitsha site B
    • Trial management and analysis
    • Specimen storage and curation towards future Biomarker development and validation
    • Human and physical research capacity building
    • Networking activities
    Main Contact Person
    Photo of Friedrich Thienemann
    Friedrich Thienemann
    Phone: +21 27 406 6084
    Photo of Robert J Wilkinson
    Robert J Wilkinson
    Phone: +21 27 406 6084
    Links
  • University of Cape Town Lung Institute (Pty) Ltd
    Short Profile

    The University of Cape Town Lung Institute (Pty) Ltd is a purpose built, clinical research facility situated at a dedicated 4 storey facility on the grounds of the Health Sciences Faculty at the University of Cape Town. The Institute is a public benefit organization and is mandated to address priority health issues through education, research and service.

    The Institute has a staff contingent of around 150, and supervises a broad based clinical trial portfolio for a range of local and international funders. Clinical trial related areas of research include tuberculosis diagnostics, tuberculosis drug development, COPD, Asthma, allergology, paediatric health, immunology and knowledge translation of primary health care into clinical practice.

    Role in the Project

    The Centre for Tuberculosis Research Innovation at the UCT Lung Institute will be conducting the Predict TB study. Our roles will include:

    • Identification of suitable trial subjects
    • Clinical trial conduct
    • Monitoring of clinical outcomes
    • Support for capacity and infrastructural development of the PredictTB consortium
    Main Contact Person
    Photo of Rodney Dawson
    Prof. Rodney Dawson
    Phone: +27 21 650 1910
    Links
  • TASK Foundation NPC
    Short Profile

    TASK Applied Science was founded in 2005 by Prof. Andreas Diacon to accelerate the development and evaluation of novel anti-tuberculosis drugs. TASK efficiently conducts studies for diagnosis, treatment or prevention of Tuberculosis and has completed several important projects in the last 12 years and contributed significantly to moving forward of the entire scientific field. TASK mainly collaborates with international NGOs, government funded consortia, academic centers and pharmaceutical companies on various drug development projects.

    TASK now employs over 150 staff members and has invested in laboratory capacity and in a network of clinical sites in underprivileged areas in Cape Town.

    Role in the Project
    • Clinical trial conduct in accordance with the protocol, local regulations and GCP
    • Maintaining accurate records of clinical outcomes and safety matters
    • Provide trial related medical care and support to trial participants
    • Label, use and storage of IP in accordance with the protocol and local guidelines
    • Capacity and infrastructure development
    Main Contact Person
    Photo of Andreas H. Diacon
    Prof. Andreas H. Diacon
    Phone: +21 917 1044/5
    Links

Four partner sites in Henan Province will be enrolling and following-up 200 patients with drug sensitive pulmonary TB, and contribute to data analysis.

In the clinical trial, participants will receive HRZE for 8 weeks, followed by discontinuation of PZA and ethambutol. Those who meet early treatment completion criteria will be randomized at Week 16 either to continue therapy for the standard duration or to complete early at week 16, whereas failure to meet early completion criteria will continue on the standard regimen. All subjects will be followed until 72 weeks with the primary endpoint evaluated at 18 months.

  • Fudan University
    Short Profile

    Fudan University was established in 1905 as Fudan Public School. With years of development, Fudan has become a comprehensive research university with ten disciplines including philosophy, economics, law, education, literature, history, science, engineering, medical science and management. Fudan takes pride in its balanced strengths in arts, science and medical science. In recent years, the University has promoted interdisciplinary development and emerging science development to facilitate discipline development into world-class level.

    Role in the Project
    • China administrative lead organization
    • Technical support on sputum collection: to standardise the procedure of expectoration and sputum induction
    • Relapse Identification: to confirm a relapse case by comparing the genotypes of Mtb strains isolated from previous and latter episodes
    • Heteroresistance Assessment: to identify heteroresistance using deep sequencing of clinical isolates
    • Transcriptome Characteristics Analysis: to analysis the transcriptome markers based on RNA-seq
    • Immunological Markers Validation: to detect blood cytokine signatures and to evaluate their ability to predict TB
    Main Contact Person
    Photo of Qian Gao
    Qian Gao
    Phone: +86 13671645425
    Links
  • Henan Provincial Institute of Tuberculosis Prevention and Control
    Short Profile

    Henan Center for Disease Control and Prevention (Henan CDC) is a technical guidance center for disease prevention and control in the Henan Province. Henan CDC undertakes technical support for disease prevention, control, health supervision and enforcement, including the development of prevention and control programs such as infectious diseases, parasitic diseases, endemic diseases, chronic noninfectious diseases. Henan CDC is also responsible for technical specifications and programs, and oversees the province's public health emergency monitoring and early warning system. The Henan Provincial Institute of Tuberculosis Prevention and Control is one of nine institutions, and it is responsible for tuberculosis prevention and control work, set up of the tuberculosis reference laboratory, tuberculosis control section, and tuberculosis information management sub-departments. The Tuberculosis Reference Laboratory is the Key Laboratory of Tuberculosis Reference Medicine in Henan Province, including the China-US Joint Research Laboratory of Tuberculosis. The laboratories available for the project include BSL-2, BSL-2+ and BSL-3 facilities.

    Role in the Project
    • Sample collection, transportation, and Mycobacterium culture for all clinical sites
    • Mycobacterium tuberculosis identification
    • Maintains the biorepository for the study
    • Research data collection and upload
    • Quality control of operations and research data
    • Quality control, supervision, and technical support and related coordination on the different CDC site research work
    Main Contact Person
    Photo of Jin Xing
    Jin Xing
    Phone: +86 0371 68089286
  • Henan Provincial Chest Hospital
    Short Profile

    Henan Provincial Chest Hospital (HPCH), is the only tertiary specialist hospital in Henan province; it oversees disease prevention, scientific research, and teaching. HPCH specializes in cardiovascular disease and respiratory disease. It was founded in 1984, with cardiovascular medicine, heart vascular surgery, thoracic surgery, minimally invasive surgery, respiratory medicine, tuberculosis, and other clinical departments as centers of excellence in Henan Province. The hospital is also the clinical center of tuberculosis treatment in Henan province. It now has 1,000 beds and more than 1,300 staff members. The hospital is the hosting partner of the Sino-US Tuberculosis Research Center established in 2009.

    Role in the Project
    • Study site for the Predict TB study
    • Participant screening, enrolment and follow up
    • Sample collection, testing, and storage on site
    • Coordinating site for PET/CT scanning of all study participants
    Main Contact Person
    Photo of Xin Liu
    Xin Liu
    Phone: +86 138 3717 1629
    Photo of Zhu Hong
    Zhu Hong
    Phone: +86 371 6557 9050
    Links
  • Kaifeng City Institute of Tuberculosis Prevention and Control
    Short Profile

    Kaifeng City Institute of Tuberculosis Prevention and Control (KCITPC) is a pulmonary hospital. It is responsible for the diagnosis, treatment and management of tuberculosis and respiratory diseases. KCITPC also provides professional training and tuberculosis emergency treatment. More than 700 tuberculosis cases in Kaifeng City were registered every year for treatment and management, while more than 2,000 cases in surrounding counties were also identified and registered at KCITPC. The DOTS program practiced by KCITPC allows for greater than 90% of the patients to be cured. KCITPC has consistently completed the tasks for tuberculosis control issued annually by the Provincial Health Department, while also participating in a number of major national science and technology research programs.

    Role in the Project
    • Clinical study site enrolling participants into study
    • Surveillance institution managing the diagnosis, treatment and follow-up for TB patients
    Main Contact Person
    Photo of Yuping Huang
    Yuping Huang
    Phone: +86 13937861821
    Photo of Yahong Qu
    Yahong Qu
    Phone: +86 13949425558
    Links
  • Xinmi City Institute of Tuberculosis Prevention and Control
    Short Profile

    Xinmi City Institute of Tuberculosis Prevention and Control, established in 1981, merged into the Xinmi CDC in 1984 and, with 12 staff members, set up clinics, clinical labs, a radiation department and other departments. It is responsible for 890,000 people in Xinmi city for the TB prevention and control. It is the city's center of tuberculosis diagnosis and treatment, prevention management, registration, publicity and training, technical guidance and scientific research. So far, it has treated and managed more than 13,000 case of tuberculosis, has published more than 120 academic papers, received six scientific research awards, while also being awarded as the ‘national advanced units’ three times by the State Ministry of Health.

    Role in the Project
    • Clinical study site enrolling participants for the Predict Study
    • Responsible for participants screening, enrolment and follow up
    • It is one of sites for National drug resistance surveillance, and experienced in the management of TB patients and collection of clinical samples
    Main Contact Person
    Photo of Xiaowei Jin
    Xiaowei Jin
    Phone: +86 13939088831
  • Zhongmou County Center for Disease Control and Prevention
    Short Profile

    Zhongmou County Center for Disease Control and Prevention was founded in 1960, covers an area of 5,732 square meters, and has 130 professional and technical staff members, including 86 undergraduates and post graduates, and 14 senior titles. It is responsible for disease prevention and control, health monitoring, public health emergency treatment, health education, national basic public health services and other tasks in Zhongmou City. Zhongmou CDC has assumed many national science and technology projects, and its tuberculosis research has been published in "Lancet".

    Role in the Project
    • Clinical study site enrolling participants for Predict Study
    • Works as a surveillance institution managing the diagnosis, treatment and follow-up for TB patients
    Main Contact Person
    Photo of Dakuan Wang
    Dakuan Wang
    Phone: +86 13503451155
    Links

European partners will be in charge of test development and data analysis (LUMC), project management (LINQ), and dissemination support (Eurice).

Robert Wilkinson (Imperial College) and Friedrich Thienemann (University of Zurich) are also affiliated with Cape Town University and will lead on-site activities there.

  • Leiden University Medical Centre
    Short Profile

    The LUMC Dept. of Infectious Diseases (Inf. Dis, Tom Ottenhoff and Annemieke Geluk) has a longstanding and extensive research program on TB and related mycobacterial infectious diseases such as leprosy. Its research scope is fundamental, preclinical, translational as well as clinical in nature and includes partly humanized animal models of TB. Its aims are to develop better vaccines, to identify new (immune-, genetic- and metabolic) biomarkers as correlates of risk of developing disease or of protective immunity against TB and leprosy. The work has led to a number of first-in-man clinical studies with new, molecularly defined synthetic TB vaccines.

    The LUMC Department of Molecular Cell Biology (Paul Corstjens) has extensive experience in design of point-of-care tests utilizing state-of-the-art upconverting nanomaterials labels. This has resulted in the development of user-friendly lateral flow assay (LFA) based on upconverting phosphor technology for several infectious diseases such as Schistosomiasis, HIV and RSV. The same assay platform is applicable to detect various targets in different bodily fluids as e.g. urine, saliva pleural fluids and nasopharyngeal washes. A plain and basic modification of the platform allows a high degree of multiplexing.

    Using the expertises of both Departments, LUMC has developed and field-tested immunodiagnostic tests for rapid (simultaneous) detection of multiple (host) protein biomarkers (cytokines and antibodies) in blood applicable for diagnosis of TB and leprosy. Within the PredictTB project these tests will be adapted for and applied to monitoring of TB treatment.

    Role in the Project
    • Evaluate applicability for UCP-LF format of host inflammatory markers (identified in WP2) using samples from the biorepository.
    • Development of point-of-care lateral flow assay (LFA) for simultaneous measurement of approximately 6 serum host inflammatory markers to identify patients with high risk for relapse
    • Implement point-of-care LFA to eventually replace PET/CT.
    Main Contact Person
    Photo of Annemieke Geluk
    Annemieke Geluk
    Phone: +31 71 5261974
    Photo of Paul L.A.M. Corstjens
    Paul L.A.M. Corstjens
    Phone: +31 71 5269209
    Links
  • LINQ management GmbH
    Short Profile

    LINQ is a research consulting company and project management partner that helps clinicians and scientists from around the world to identify the most suitable funding sources for collaborative research initiatives, to enhance the competitiveness of grant applications, and to ensure the effective oversight and management of research projects in a variety of programmes – both national (e.g. BMBF and BMG in Germany, or MRC/BBSRC in the UK) as well as international (Horizon2020, EDCTP2, IMI2 and others). LINQ strives to keep things simple, enabling project partners to focus on the actual science, produce results that have an impact, and build networks that last. The company‘s service portfolio includes strategic consultancy, tailored advice on funding opportunities, comprehensive proposal support, professional management of research projects from small initiatives to large clinical studies, and a wide array of trainings e.g. on funding opportunities, proposal writing, project and financial management.

    Role in the Project
    • Project Management Office for EDCTP PredictTB project
    • Leader of Work Package 1 (Project Management) of EDCTP PredictTB project
    • Strategic advice and support of networking
    • Coordinating overall PredictTB trial management activities with FNIH/NIH/BMGF
    • Capacity building and training
    Main Contact Person
    Photo of Claudia Schacht
    Dr Claudia Schacht
    Phone: +49 30 65 00 86 60
    Photo of Julia Buech
    Julia Buech
    Phone: +49 6894 92 808 10
    Links
  • European Research and Project Office GmbH
    Short Profile

    The European Research and Project Office GmbH – EURICE offers comprehensive support services for the planning, initiation, and implementation of international collaborative research and innovation projects with competencies in project, communication and innovation management. Eurice’s portfolio includes all aspects of project management: from strategic project planning and proposal writing to successful project implementation and exploitation of research results.

    Founded in 2000, Eurice is headquartered in Saarbrücken, Brussels and Berlin and is one of the largest research and innovation management companies in Europe with a long track record as international full-service provider for researchers, universities, institutes and industry. To date, Eurice has been involved in the implementation of more than 250 European collaborative projects covering all major fields of research. The company is particularly focused on Horizon 2020, the largest ever EU Research and Innovation programme which is running from 2014-2020 and comes with many new opportunities but also more competitiveness.

    In addition to classic project management, Eurice offers strategic and operational support on communication and exploitation to maximise the value of project results through its extended network of internal and external Intellectual Property (IP) and innovation experts. Eurice partners benefit from many years of experience in managing communication and IP-related issues in European R&D projects, and profit from the company’s role as service partner of the European Commission for innovation support.

    Role in the Project
    • Project communication
    • Project branding & communication material
    • Support outreach activities
    Main Contact Person
    Photo of Stephanie Weber
    Stephanie Weber
    Phone: +49 681 95923394
    Photo of Caroline Schorn
    Caroline Schorn
    Phone: +49 681 95923397
    Links
  • Imperial College London
    Short Profile

    HIV and TB are amongst the most pressing public health problems in Africa. The epidemiology of HIV associated TB is well researched, but few studies have addressed in detail the mechanisms. This programme aims to answer questions arising from the clinical care of patients with these infections. Over time the emphasis has increasingly encompassed the need for novel interventions. Projects underway at present include the following.

    • How can tuberculosis infection in HIV infected people be more effectively diagnosed and prevented?
    • What is the cause and best management of the HIV-Tuberculosis-associated Immune Reconstitution Inflammatory Syndrome?
    • What is the pathogenesis of tuberculous pericarditis?
    • What is the Biology of human latent tuberculosis and how is tthis alterned by HIV-1 co-infection?

    Role in the Project
    • Clinical trials experience, oversight and management
    • Performing genomic and proteomic analysis of biomarker samples
    • Human capacity building
    • Networking
    Main Contact Person
    Photo of Robert J Wilkinson
    Robert J Wilkinson
    Phone: +44 207 594 3891
    Links
  • University Hospital Zurich / University of Zürich
    Short Profile

    The University Hospital Zurich is one of the largest hospitals in Switzerland and affiliated with the University of Zurich. The Department of Internal Medicine provides specialist care for complex patients with multi-morbidities. The department has a long-standing academic and research history from basic science to clinical research and the conduct of clinical trials. With the recruitment of Dr. Thienemann, we aim to extend our research network and partnership to Africa to contribute to research in multimorbidity in low and middle-income countries, with focus on patients with chronic infections such as tuberculosis and HIV.

    Role in the Project
    • Dr Thienemann is the Co-Principal Investigator at the Khayelitsha site in South Africa
    • Clinical trial overview and clinical lead of the Khayelitsha site in South Africa
    • Member of the clinical trial oversight committee, CTOC
    • PET/CT reading and analysis
    Main Contact Person
    Photo of Friedrich Thienemann
    Dr med. Friedrich Thienemann
    Phone: +41 (0)44 255 40 89
    Links

The US NIH will be in charge of overall project coordination, data storage & analysis, while FNIH will be providing project management support.

  • The Foundation for the National Institutes of Health
    Short Profile

    The Foundation for the National Institutes of Health creates and manages alliances with public and private institutions in support of the mission of the NIH, the world’s premier medical research agency. The Foundation, also known as the FNIH, works with its partners to accelerate biomedical research and strategies against diseases and health concerns in the United States and across the globe. The FNIH organizes and administers research projects; supports education and training of new researchers; organizes educational events and symposia; and administers a series of funds supporting a wide range of health issues. Established by Congress in 1990, the FNIH is a not-for-profit 501(c)(3) charitable organization. For additional information about the FNIH, please visit fnih.org.

    Role in the Project
    • Day-to-day administrative requirements
    • Primary administrative contact for the Bill and Melinda Gates Foundation (BMGF) grant award. Management of reporting to the Gates Foundation.
    • Responsible for monitoring progress through tracking and reviewing of bi-annual progress and financial reports from the sub-grantees
    • Organization of annual team meetings
    Main Contact Person
    Photo of Tiffany Francis
    Tiffany Francis
    Phone: +01 301 402 0508
    Links
  • National Institutes of Health
    Short Profile

    The National Institutes of Health is one of the world's foremost medical research centers, and the Federal focal point for medical research in the United States. The NIH, comprising 27 separate Institutes and Centers, is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. The NIH headquarters are located in Bethesda, Maryland. NIH scientists conduct their research in laboratories located on the NIH campus, and in several field units across the country and abroad.

    Role in the Project
    • Clifton E Barry 3rd, Chief, Tuberculosis Research Section, NIAID is principal investigator for Predict TB. His clinical team will manage the overall programmatic and logistical aspects of the clinical protocol to achieve the goals, objectives and milestones of Predict TB
    • The National Institute of Allergy and Infectious Diseases (NIAID) will act as sponsor for the protocol and the NIAID IRB reviewed and approved the protocol and will provide oversight monitoring for the protocol. The NIAID DSMB will review the ongoing safety and integrity of the study subjects and the data.
    • Design and management of project database
    • Statistical oversight of the data
    Main Contact Person
    Photo of Laura Via
    Laura Via
    Phone: +01 301 451 9554
    Links
  • Catalysis Foundation for Health
    Short Profile

    The Catalysis Foundation for Health, founded in 2007, is dedicated to facilitating the efficient discovery, development, manufacture and distribution of modern diagnostic tests to address life-threatening infectious diseases and chronic conditions that are endemic in the developing world.

    Role in the Project
    • Scientific oversight for the Project
    • Facilitate communication between all sites
    • Provide scientific reporting to funders
    Main Contact Person
    Photo of Jill Winter
    Jill Winter
    Phone: +01 510 2895766
    Links