ExpectedOutcome:
This topic aims at supporting activities that contribute to at least two of the expected impacts for this call. Proposals under this topic should aim at delivering results that are contributing to the following expected outcomes:
- Accelerate development of therapeutics towards registration to make progress in the control and elimination of NTDs in sub-Saharan Africa;
- Improve the understanding of barriers for progression of existing and new therapeutics against NTDs through the R&D pipeline;
- Generate evidence-based recommendations on how to better integrate research and innovation in efficient supply chains for NTDs;
- Gain a better understanding of different country or region-specific health and research needs, to ensure a better case management of patients with NTDs;
Scope:
Background:
There is some progress in eliminating and eradicating NTDs as per WHO publication[1] in October 2023: “nineteen countries in Africa have eliminated at least one NTD and there are currently 18 million fewer people requiring interventions against NTDs. Togo achieved a world first by eliminating four NTDs. Guinea worm disease (dracunculiasis) is on the verge of eradication; sleeping sickness (T. b. gambiense human African trypanosomiasis) has been eliminated as a public health problem in seven countries; and the number of reported Buruli ulcer cases decreased by 71% between 2010 and 2021”. However, diseases such as schistosomiasis, onchocerciasis, and other NTDs continue to affect hundreds of millions of people who are most often society’s poorest, in sub-Saharan Africa. The WHO Global report provides information for 2021-2022 on regional progress in Africa NTDs[2].
Many of NTDs are vector-borne diseases (NTD vector control is in scope of topic HORIZON-JU-GH-EDCTP3-2024-CALL1-01-05 of this call: new tools, technologies and approaches for vector control in sub-Saharan Africa), have animal reservoirs and are associated with complex life cycles. The epidemiology of NTDs is complex and multifactorial, often related to environmental conditions, that makes their public-health control challenging. Moreover, COVID-19 pandemic severely disrupted health systems, including conduct of clinical trials, supply chains for NTD therapeutics and health products and the implementation of prevention strategies. Thus, pharmaceutical interventions combined with interventions such as house improvements, improved access to safe water, sanitation and hygiene (WASH) are also critical in the prevention for the majority of the NTDs, especially[3] for Trachoma, Soil-transmitted helminthiases (STHs), Schistosomiasis and Dracunculiasis.
Scope:
The proposals submitted to this call topic are expected to address at least one of the following activities in scope:
- Conduct clinical trials on therapeutics for NTDs in the scope of the Global Health EDCTP3JU:
Buruli ulcer, dengue and chikungunya, dracunculiasis (guinea-worm disease), echinococcosis, foodborne trematodiases, human African trypanosomiasis (sleeping sickness), leishmaniases, leprosy (Hansen disease), lymphatic filariasis, mycetoma, onchocerciasis (river blindness), rabies, schistosomiasis, soil-transmitted helminthiases, taeniasis/cysticercosis, trachoma, and yaws. Global Health EDCTP’s remit will not cover chromoblastomycosis and other deep mycoses, scabies and other ectoparasites, and snakebite envenoming.
- For existing therapeutics for specific indications, there is need to conduct clinical trials of combination therapies against multiple diseases and applicability to vulnerable populations
- For infections where therapeutics are lacking entirely, clinical trials will be required for the development of new interventions (early stage) or extension of indications (re-purposing)
- Implementation research of pharmaceutical interventions for several NTDs and, when possible, their mainstreaming into national health systems in combination with other control measures
Where possible, collaboration and coordination with the Team Europe Initiative on Manufacturing and health products (TEI-MAV+) is encouraged. The proposals could show, for example, willingness to enter into technology transfer agreements with African counterparts - including the provision of patents, technical knowledge and know-how -, or early engagement with regulators or with African manufacturers to support the translation into affordable products adapted to the regional market.
Activities related to community engagement are encouraged in the context of developing new pharmaceutical interventions targeting NTDs.
Applicants need to concisely describe any prior research findings and explain how the proposal builds on these results.
The research to be conducted must involve vulnerable groups, including participants from poorer, underserved or hard-to-reach communities in sub-Saharan Africa. The full range of relevant determining characteristics (sex, gender, age, socio-economic status, etc.) needs to be considered.
Applicants are also encouraged to provide methodologies for translating research findings into public health practice and policy guidelines.
The proposals should involve all stakeholders, most notably policy makers, public health authorities, health care professionals and end-users. Activities related to community engagement are encouraged in the context of developing new pharmaceutical interventions targeting NTDs. International cooperation is encouraged, and the proposed implementation research for pharmaceutical interventions is expected to be multidisciplinary through the involvement of medical sciences, psychological sciences, social sciences and the humanities.
All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. The details of these joint activities will be defined during the grant agreement preparation phase.
Applicants are reminded of the expectation that proposals should come from research consortia with a strong representation of institutions and researchers from sub-Saharan African countries, including involvement of Lranco/Lusophone countries if possible. Applicants are also reminded of the expectation of reaching out to organisations in countries with relatively lower research capacities.
[1]Ending the neglect: lessons from a decade of success in responding to Neglected tropical diseases in Africa
[2]Global report on neglected tropical diseases 2023 (who.int)
[3]Information on cross-cutting issues in NTDs | InfoNTD
Expected Impact:
Activities funded under the 2024 work programme of the Global Health EDCTP3 JU calls for proposals should contribute to:
- reduce the individual, social, and economic burdens of infectious diseases in sub-Saharan Africa through the development and uptake of new or improved interventions, and
- increase health security in sub-Saharan Africa and globally by reducing the risk of outbreaks and pandemics and enhancing national and regional capacity to address antimicrobial resistance.
- Progressing towards the achievement of SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’ in sub-Saharan African (SSA) countries;
- Enable the implementation of the short- and medium-term actions foreseen by the AU EU Innovation Agenda (adopted in July 2023) in the area of public health and the EU Global Health Strategy (November 2022);
- Improve equitable access to a full range of essential health services from health promotion to disease prevention and affordable quality treatment, rehabilitation and palliative care to fight communicable diseases;
- Expand partnerships based on equal footing, co-ownership, mutual interest and strategic priorities;
- Provide evidence for informed health policies and guidelines within public health systems in SSA and at international level;
- Enhance sustainable global scientific collaboration in health research and international cooperation across SSA;
- Develop novel, innovative HIV therapeutics for reducing the disease burden of HIV in SSA
- Research on existing Malaria vaccines and development of new promising candidates
- Accelerating development and integration of therapeutics against neglected tropical diseases (NTDs) in SSA;
- Tackle Antimicrobial Resistance (AMR) through R&D in novel and existing antimicrobials
- Develop new tools, technologies and approaches for vector control in SSA;
- Develop innovative digital health solutions for SSA.
- Build appropriate local capacity.
