New TB diagnostics
Current strategies are insufficient to control tuberculosis (TB) in sub-Saharan Africa, particularly to limit transmission in individuals already infected with HIV. Several novel and improved technologies have recently been developed to improve diagnosis. However, they have not adequately been tested in field trials. In contrast to other infectious diseases, there are currently no commercially-available, accurate and validated point-of-care (POC) tests for TB.

The EDCTP-funded TB-NEAT consortium, led by Prof. Kertan Dedha, seeks to facilitate the development of POC tests for TB, and to validate new technologies in day-to-day clinical primary-care practice in Africa. The project is to evaluate these new technologies for TB diagnosis in smear-negative and HIV-infected persons in countries highly afflicted by HIV and TB. The programme includes a large field trial. At the same time the programme will establish high quality field testing sites and bio-banks, and train African scientists.

In the TB-NEAT consortium, the team of EDCTP Senior Fellow Prof. Mark Nicol, is conducting a study of the impact of the GeneXpert test at clinic and patient level. The study is still underway, and preliminary results showed a potentially great impact of the test on improving the diagnosis of TB in settings of high HIV prevalence. These results were a substantial component of a report submitted to the WHO Strategic and Technical Advisory Group (STAG) for TB that endorsed the use of GeneXpert for diagnosing tuberculosis.

PanACEA: the push for shortening and simplifying TB treatment
The current standard TB treatment takes six months to complete. Many patients do not fully complete their cure. This leads to treatment failure and, possibly, the emergence of drug resistant strains of the bacterium. Therefore, new anti-TB drugs that will also shorten treatment are urgently needed.

EDCTP has granted funding for a consortium of three European universities and 12 African trial sites, providing an overarching structure for three drug development programmes. This Pan African Consortium for Evaluation of Antituberculosis Antibiotics (PanACEA) aims to shorten and simplify TB therapy through conducting clinical trials in conformity to regulatory standards; to establish the required registration-quality clinical trial capacity at 12 sites in sub-Saharan Africa; and to develop an enduring framework for the current and future clinical trials for TB drugs.

The three projects under the umbrella of PanACEA are:

1. Rapid evaluation of Moxifloxacin in tuberculosis (REMox), under the medical responsibility of University College of London (UK);
2. Evaluation of a novel TB Drug (SQ109), under the medical responsibility by Klinikum der Universität München Department of Infectious Diseases and Tropical Medicine (Germany);
3. Rapid evaluation of high dose rifampicin and other rifamycins in tuberculosis (HIGHRIF), under the medical responsibility of Radboud University Nijmegen Medical Centre (The Netherlands).

These regimens aim to reduce the duration of therapy by one third, which would have critical implications for public health.

New TB vaccine
Tuberculosis infected 9.4 million and killed 1.7 million people in 2009 including hundreds of thousands of infants and adolescents. The current vaccine shows incomplete and variable efficacy in preventing the disease. A number of candidate novel TB vaccines have been developed and will have to be tested in trials over the course of the next decade. It is expected that Phase IIB trials of new TB vaccines will need to enrol at least 700 newborns and 3500 adolescents. Phase III trials will need to enrol more than 10 000 newborns and 20 000 adolescents. Efficacy trials conducted at multiple sites involving patients from different populations should lead to more robust results. To conduct such trials each participating site would need to possess or develop registration-quality capabilities.

The EDCTP-funded project led by Prof. Gregory Hussey aims at ensuring just that. The ‘Multicentre Phase II Trial of a New TB Vaccine in African Infants’ project will see to it that four distinct trial sites in sub-Saharan Africa possess the infrastructural capacity to conduct Phase IIB and Phase III trials of new TB vaccines in the next 5 years. At these sites – the South African Tuberculosis Vaccine Initiative (SATVI), the KEMRI/CDC Field Research Station in Kenya, the Manhiça Health Research Centre (CISM) in Mozambique and the Kampala Field Site of the Makerere University in Uganda – the immunogenicity and efficacy of Crucell Recombinant Ad35 vaccine in infants will be evaluated. The expected outcome is that this vaccine will be found to be safe and effective.

About EDCTP

EDCTP aims through research integration to accelerate the development of new or improved drugs, vaccines, diagnostics and microbicides against HIV/AIDS, malaria and tuberculosis, with a focus on phase II and III clinical trials in sub-Saharan Africa.

EDCTP supports integrated multicentre projects which combine clinical trials, capacity building and networking. The aim of integrating these three activities is to ensure that the developed capacity is utilised to successfully conduct the clinical trials in a sustainable way.

The basis of EDCTP is partnership. It unites 14 participating European Union (EU) member states plus Norway and Switzerland with sub-Saharan African countries. The partnership helps EU Member States to integrate and coordinate their own national research and development programmes and form partnerships with their African counterparts.

EDCTP is currently part of the European Commission’s Sixth Framework Programme (FP6) for research and technological development, the European Union’s main instrument for funding research in Europe.

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Note to the editor:
For further information, please contact Mr Gert Onne van de Klashorst +31 (0)70 344 0885