Research and innovation
Our capacity to advance towards the elimination of HAT can be strengthened if new improved tools are developed and if our knowledge of the disease grows. The key to integrated management of the disease by local health facilities is the availability of simple and affordable diagnostic and treatment tools, adapted to an elimination context. WHO effectively contributes to research projects to develop new tools for diagnosis, such as with the Institute of Tropical Medicine in Antwerp, Belgium (ITM), the Foundation for Innovative New Diagnostics (FIND) and the Institut de Recherche pour le Développement (IRD), and for the development of new oral medicines with the Drugs for Neglected Diseases initiative (DNDi).
Other important knowledge gaps include epidemiological aspects such as the estimation of undetected cases and the epidemiological role of human asymptomatic carriers and animal reservoirs in maintaining transmission and re-emergence of HAT. Recent research strongly suggests that the skin may be a reservoir for trypanosomes, but more research is needed.
The WHO HAT specimen biobank
As part of its contribution to support research in diagnostics, WHO set up a specimen bank to facilitate the evaluation of relevant tools and to reduce the need for field trials. The specimen bank comprises more than 20 000 samples from 1800 individuals, including patients, seropositive suspected cases and negative controls from 15 sites in Chad, the Democratic Republic of the Congo, Guinea, Malawi, Uganda and the United Republic of Tanzania. Samples are stored in the central repository bank at the Institut Pasteur in Paris, France.
The biological samples of patients include serum, plasma, buffy coat, urine, saliva and cerebrospinal fluid. The aim is to provide reference clinical materials to research institutions to develop and evaluate new tests for diagnosis and staging of HAT, appropriate for use in low-income countries.
To request samples
please complete and send the form to Gerardo Priotto (priottog@who.int) or to neglected.diseases@who.int. The requests are assessed by an independent exit committee.
Efforts to develop new medicines
A major issue in ensuring sustainable control of HAT is the complexity of current therapies. New therapeutic tools that do not require particular skills or care to administer, with a simple regimen, must therefore be developed to facilitate management by peripheral health staff working in rural areas.
Phase III clinical trials of a new molecule (acoziborole) are ongoing. Acoziborole has shown promising results in preclinical and phase I/II clinical studies and is a candidate for use as a single dose oral medicine in the early and late stages of both forms of HAT. It would dramatically simplify the current treatment. Phase II/III clinical trials of fexinidazole for treatment of rhodesiense HAT are also ongoing.
Conducting clinical trials for HAT in the field presents numerous challenges. In 2014, WHO organized an experts’ consultation to update the consensus framework for clinical trials, initially developed in 2004 to help safeguard data quality and standardize methods to permit direct comparability of data from different studies.
Related publication
The Atlas of HAT as a tool for research
As WHO ensures that all HAT cases are documented in place and time, plus a few other characteristics, good epidemiological data for surveillance of the disease are generated. The data provided by the national programmes and complementary sources are included in the Atlas of HAT, which represents the main tool for monitoring the evolution of the situation at all levels, from global to village, and a resource to support the planning of field operations.
At the same time, this database is transferred to endemic countries (Angola, Cameroon, Central African Republic, Chad, Congo, Côte d'Ivoire, Equatorial Guinea, Democratic Republic of the Congo, Gabon, Guinea, South Sudan, Malawi, Uganda, United Republic of Tanzania, Zambia), together with supplies of equipment and training in its use locally.
To request data from the Atlas of human African trypanosomiasis
please send an email to Gerardo Priotto (priottog@who.int) or to neglected.diseases@who.int. The requests are assessed by an independent exit committee and authorization from the national sleeping sickness control programmes of involved countries is requested.
Collaborating centres
Four centres provide technical support to WHO’s programme as WHO collaborating centres:
- the WHO Collaborating Centre for Research and Training on human African trypanosomiasis diagnostics, based in the Parasite Diagnostics Unit of ITM in Antwerp (Belgium);
- the WHO Collaborating Centre for research on host/vector/parasite interactions to sustain surveillance, control and elimination of human African trypanosomiasis, located in the Research Unit of IRD based in Montpellier (France), with antennas in the International Centre for Research and Development in Livestock in Sub Humid Areas (CIRDES) in Bobo Dioulasso (Burkina Faso) and the Institut Pierre Richet (IPR) in Bouake (Côte d’Ivoire);
- the WHO Collaborating Centre for reference and training on diagnosis of human African trypanosomiasis, based in Laboratoire National de Référence pour la Trypanosomiase Humaine Africaine (LNRTHA) of the Institute national de recherche biomedical (INRB) in Kinshasa (Democratic Republic of the Congo); and
- the WHO Collaborating Centre for Human African Trypanosomiasis Biobank, based in the Clinical Investigation and Access to BioResources Platform (ICAReB) at the Institut Pasteur in Paris (France).
At the same time, WHO in collaboration with ITM, IRD, CIRDES, IPR and INRB works to ensure the production and expanded use of mAECT (a field-adapted parasitological technique) and supports the use of trypanolysis as a referral test. Importantly, the donation by General Electric of the gels needed to produce mAECT has significantly reduced the price of this tool.
WHO also promotes the open discussion of scientific and strategic issues via the participation in the main forums on the disease, including the biannual meetings of the International Scientific Council for Trypanosomiasis Research and Control (ISCTRC), the scientific meetings of the human African trypanosomiasis platform for research and broader scientific congresses (the European Congress on Tropical Medicine and International Health, the annual meetings of the American Society of Tropical Medicine and Hygiene, the francophone network for NTDs, the technical Meetings of the HAT subgroup in the NTD modelling consortium). WHO also participated in the Scientific Advisory Group (SAG) Anti-infectives meeting for the European Medicines Agency’s Committee for Human Medicinal Products (CHMP).