The PredictTB Consortium
PredictTB was a global approach by partners from Africa, Asia, Europe and the United States to identify biomarkers indicating treatment response and ultimately significantly shorten TB treatment in most TB patients worldwide.
Five local partner sites in Cape Town (Stellenbosch University, two sites at the University of Cape Town, the University of Cape Town Lung Institute, and TASK Foundation) enrolled and followed up 455 patients with drug-sensitive pulmonary TB, and contributed to data analysis.
In the clinical trial, participants received HRZE for eight weeks, followed by discontinuation of PZA and ethambutol. Those who met early treatment completion criteria were randomized at week 16 either to continue therapy for the standard duration or to complete it early at week 16, whereas those who failed to meet early completion criteria continued on the standard regimen. All subjects were followed until 72 weeks, with the primary endpoint evaluated at 18 months.
Stellenbosch University Immunology Research GroupShort 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
Main Contact PersonLinksProf. Gerhard WalzlPhone: +27 21 938 9401
- 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.
South African Tuberculosis Vaccine InitiativeShort 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
Main Contact PersonLinksDr Michele TamerisPhone: +27 23 346 5400
- Recruitment, enrolment and follow up of participants
- Processing and storage of immunology samples (WBA)
- Protocol development
- Reporting of results
Wellcome Centre for Infectious Diseases Research in AfricaShort 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:Role in the Project
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.
Main Contact PersonLinksFriedrich ThienemannPhone: +21 27 406 6084Robert J WilkinsonPhone: +21 27 406 6084
- 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
University of Cape Town Lung Institute (Pty) LtdShort 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:
Main Contact PersonLinksProf. Rodney DawsonPhone: +27 21 650 1910
- Identification of suitable trial subjects
- Clinical trial conduct
- Monitoring of clinical outcomes
- Support for capacity and infrastructural development of the PredictTB consortium
TASK Foundation NPCShort 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
Main Contact PersonLinksProf. Andreas H. DiaconPhone: +21 917 1044/5
- 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
Five partner sites in Henan Province enrolled 231 patients with drug-sensitive pulmonary TB, and contributed to data analysis.
In the clinical trial, participants received HRZE for eight weeks, followed by discontinuation of PZA and ethambutol. Those who met early treatment completion criteria were randomized at Week 16 either to continue therapy for the standard duration or to complete it early at week 16, whereas those who failed to meet early completion criteria continued on the standard regimen. All subjects were followed until 72 weeks with the primary endpoint evaluated at 18 months.
Fudan UniversityShort 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
Main Contact PersonLinksQian GaoPhone: +86 13671645425
- 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
Henan Provincial Institute of Tuberculosis Prevention and ControlShort 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
Main Contact PersonJin XingPhone: +86 0371 68089286
- 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
Henan Provincial Chest HospitalShort 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
Kaifeng City Institute of Tuberculosis Prevention and ControlShort 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
Main Contact PersonLinksYuping HuangPhone: +86 13937861821Yahong QuPhone: +86 13949425558
- Clinical study site enrolling participants into study
- Surveillance institution managing the diagnosis, treatment and follow-up for TB patients
Xinmi City Institute of Tuberculosis Prevention and ControlShort 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
Main Contact PersonXiaowei JinPhone: +86 13939088831
- 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
Xinxiang City Institute of TB and Control
The Xinxiang Tuberculosis Prevention and Treatment Institute was established in March 1980. It is the designated unit of the Municipal Medical Insurance Bureau and the New Rural Cooperative Medical System. The institute has 39 in-service employees, including 33 professional and technical personnel. There are 70 specialized observation beds for tuberculosis, and more than 30 pieces of advanced tuberculosis screening and diagnostic equipment, including digital photography X-ray imaging system (DR), American BACTEC960 tuberculosis culture and drug sensitivity analyser. It is the only tuberculosis control, prevention and treatment institution in the city of Xinxiang, undertaking tuberculosis diagnosis and treatment, supervision and management, public education, scientific research and training, epidemiological investigation, and medical guidance to 8 counties and 4 districts in Xinxiang, a population of nearly 6 million.
Zhongmou County Center for Disease Control and PreventionShort 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
Main Contact PersonLinksDakuan WangPhone: +86 13503451155
- Clinical study site enrolling participants for Predict Study
- Works as a surveillance institution managing the diagnosis, treatment and follow-up for TB patients
European partners were 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) were also affiliated with Cape Town University and led on-site activities there.
Leiden University Medical CentreShort 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
Main Contact PersonLinksAnnemieke GelukPhone: +31 71 5261974Paul L.A.M. CorstjensPhone: +31 71 5269209
- 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.
LINQ management GmbHShort 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
Main Contact PersonLinksDr Claudia SchachtPhone: +49 30 300 96441Dr Christoph CyranskiPhone: +49 30 300 96447Malte StreitzPhone: +49 30 300 96443
- 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
European Research and Project Office GmbHShort 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
Main Contact PersonLinksStephanie WeberPhone: +49 6894 388 1316
- Project communication
- Project branding & communication material
- Support outreach activities
Imperial College LondonShort 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
Main Contact PersonLinksRobert J WilkinsonPhone: +44 207 594 3891
- Clinical trials experience, oversight and management
- Performing genomic and proteomic analysis of biomarker samples
- Human capacity building
University Hospital Zurich / University of ZürichShort 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
Main Contact PersonLinksDr med. Friedrich ThienemannPhone: +41 (0)44 255 40 89
- 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
The US NIH was in charge of overall project coordination, data storage & analysis, while FNIH provided project management support.
The Foundation for the National Institutes of HealthShort 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
Main Contact PersonLinksTiffany FrancisPhone: +01 301 402 0508
- 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
National Institutes of HealthShort 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
Main Contact PersonLinksLaura ViaPhone: +01 301 451 9554
- 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
Catalysis Foundation for HealthShort 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
Main Contact PersonLinksJill WinterPhone: +01 510 2895766
- Scientific oversight for the Project
- Facilitate communication between all sites
- Provide scientific reporting to funders