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World TB day 2017: closing the gaps to end tuberculosis

24 March 2017

Ending the tuberculosis (TB) epidemic by 2030 is one of the health targets of the Sustainable Development Goals. Although TB incidence has fallen by an average of 1.5% per year since 2000, TB is still one of the top 10 causes of death worldwide. Over 95% of TB deaths occur in low- and middle-income countries. In 2015, an estimated 480,000 people globally developed multidrug-resistant TB (MDR-TB). This ambitious aim to end the TB epidemic by 2030 can only be achieved by uniting efforts to close the research gaps.

Priorities for tuberculosis

In its strategic business plan for 2014-2024, EDCTP has identified important areas of unmet medical need for each of its target disease areas as well as for research capacity development. Important goals for TB research include:

  • Find new approaches for early diagnosis of active TB
  • Shorten the duration of therapy, where appropriate
  • Improve treatment for both drug-sensitive and drug-resistant TB, which will prevent relapse, reduce the emergence of drug resistance, and prevent long-term lung damage and latent TB infection progressing to active TB.

Ultimately, TB control will require affordable, short, effective and well-tolerated treatments for all forms of TB (i.e., latent TB infection, drug-susceptible and drug-resistant TB disease), point-of-care diagnostic tests able to characterise drug resistance, and an effective vaccine.

“Combatting all forms of TB and its interaction with other poverty-related and neglected diseases, through R&D on new or improved tools for better diagnosis, prevention, treatment and point-of-care evaluation of these interventions remains a major priority for EDCTP.”

Dr Michael Makanga, EDCTP Executive Director

TB research received the largest share of funding in the project portfolio of EDCTP’s first programme, with a total of € 68.96 million (33.2%) for 36 projects. Since the start of the second EDCTP programme in 2014, EDCTP has invested €26.42 million to support 7 projects in TB.

Shortening TB treatment

The PanACEA consortium (Pan-African Consortium for the Evaluation of Antituberculosis Antibiotics) funded under the first EDCTP programme delivered an extensive drug development portfolio with six clinical trials. The consortium recently held a kickoff meeting of their new awarded grant under the second EDCTP programme (PanACEA2).

The PanACEA2 programme aims to develop at least two promising TB-treatment regimens with sound prediction data for a successful phase III evaluation, and to advance one new agent into phase IIb. It will take full advantage of state of the art technologies, including innovative trial designs, new microbiological markers of treatment response, pharmacokinetic-pharmacodynamic analyses and modelling techniques. As a result, drug development processes could be accelerated by several years. PanACEA2 trial activities will be conducted at 11 research sites in six countries (Gabon, Malawi, Mozambique, South Africa, Tanzania, and Uganda) in sub-Saharan Africa with integrated research capacity development.

Streamlining diagnostic approaches of active TB

The African European Tuberculosis Consortium (AE-TBC), funded under the first EDCTP programme, identified a seven-marker serum protein biosignature for the diagnosis of TB irrespective of HIV status and ethnicity in Africa. The ScreenTB project, funded under the second EDCTP programme, will use some of the biomarkers of the AE-TBC project to develop a point-of-care, field-friendly device which is based on finger-prick blood testing. The device’s accuracy (sensitivity and specificity) will be tested against gold standard diagnostic tools (such as Xpert MTB/RIF, MGIT culture, TB sputum smear, CXR).

The successful implementation of a sensitive, cost-effective screening test would streamline diagnostic programmes in resource-limited settings and could decrease unnecessary referrals for expensive GeneXpert testing by 75%.

Developing scientific leadership on TB

As part of its research capacity development strategy, EDCTP also supports African expertise and scientific leadership through training, mentoring and by providing career development opportunities for African researchers, from master’s and PhD training through to senior fellowships.

Professor Grant Theron, first a post-doc student in the TB-NEAT study (funded under the first EDCTP programme) and now professor at Stellenbosch University, was recently granted a Senior Fellowship under the second EDCTP programme. The Optimal Diagnosis study led by Prof. Theron, will evaluate the feasibility, accuracy, and effectiveness of new, ultra-sensitive point-of-care tests for TB and drug-resistance in HIV high-burden setting of Cape Town, South Africa while also building research capacity. In addition to collecting novel data on the accuracy and potential impact of new point-of-care tests for TB, this project is expected to inform on how they can be optimally used.

TB research initiated by EDCTP member countries

Clinical research activities initiated by EDCTP member countries (or Participating States) within the scope of the EDCTP programme can be considered to be part of the programme. These projects, called PSIAs (Participating States’ Initiated Projects), are supported with national funding and independently executed by European and African member countries. The PSIAs are important as they directly contribute to achieving the EDCTP objectives and are incorporated in the EDCTP work plans.

Some of the PSIAs are multi-country activities, in which more than two Participating States collaborate. One example is the collaboration of three European countries – Denmark, Netherlands and Norway – who initiated a phase II trial to evaluate one of the leading TB vaccine candidates (H56:IC31) in Tanzanian and South African adolescents. The project started in 2016 and brings together Norway (GLOBVAC, University of Bergen and Oslo University Hospital), Denmark (Statens Serum Institut, University of Copenhagen and GSK Europe), Netherlands (Leiden University Medical Center), South Africa (Aeras South Africa, The Aurum Institute, South African TB Vaccine Initiative (University of Cape Town)), Tanzania (National Institute for Medical Research, Mwanza), and the United States (Aeras).