HORIZON-JU-GH-EDCTP3-2025-01-NTD-03-two-stage
Topic description
Expected Outcome:
Background
Neglected Tropical Diseases (NTDs) represent a challenge to public health, particularly in the African continent, where their prevalence is intertwined with socio-economic disparities. In January 2021, the WHO published the report “Ending the neglect to attain the sustainable development goals: a roadmap for neglected tropical diseases 2021-2030” followed by 2024 WHO Global report which is the second in a series of global reports describing progress towards the 2030 targets set in the road map for neglected tropical diseases 2021–2030. The road map sets global targets and milestones to prevent, control, eliminate or eradicate 20 diseases and disease groups as well as cross-cutting targets aligned with the Sustainable Development Goals. Three foundational pillars will support global efforts to achieve the targets: accelerate programmatic action (pillar 1), intensify cross-cutting approaches (pillar 2) and change operating models and culture to facilitate country ownership (pillar 3). The overarching global targets described in this report, in line with the SDGs and the WHO’s 13th General Programme of Work are to ensure 90% fewer people requiring interventions against NTDs, 75% fewer NTD-related DALYs and 100 countries achieving elimination of at least one NTD and eradication of two NTDs (Dracunculiasis and Yaws).
2023 Annual WHO African region report mentions: “ Nineteen countries in the WHO African Region have successfully eliminated at least one NTD, with Togo notably eliminating four: Guinea worm disease, lymphatic filariasis, human African trypanosomiasis (HAT) (gambiense), and trachoma”.
As progress is made on the therapeutics front with tangible impact from EDCTP2 investments, it has been increasingly evident that vaccine development represents a very valuable solution. Today, Dengue, Chikungunya and Rabies are the only NTDs that can be prevented through vaccination, but cost and availability still limit their more widespread use. Moreover, the development of NTD vaccines, including those for schistosomiasis, leishmaniasis, leprosy, hookworm, and Chagas disease are led by nonprofit product development partnerships with a need for more funds to address translational activities.
In this context, the Global Health EDCTP3 programme is aiming to contribute significantly to the fight against NTDs and alleviate the disease burden in Africa aligning with SDGs and fostering improved health outcomes for the most vulnerable populations. It aims to unite the collective intersectoral efforts ofresearchers, policymakers, and healthcare practitioners, ensuring inclusivity for all.
Expected Outcome
This topic aims at supporting activities that contribute to one or several of the expected impacts for this call. Proposals submitted under this topic should aim for delivering results that are directed, tailored towards and contributing to following one of the expected outcomes:
Generate data on novel or existing vaccines (Phase II/Phase III trials) to make progress towards prevention, control and elimination of NTDs in SSA (note: in case of no or limited vaccine candidates in development, early development is encouraged (Phase I onwards);
Improve the understanding of barriers for progression of new or improved vaccines against NTDs through the R&D pipeline;
Generate clinical data including pregnant and lactating women, new-borns, children, adolescents, other vulnerable and neglected populations, and people with co-infections and co-morbidities at risk in SSA as relevant.
Scope:
Scope
The objective of the topic is to progress the development of prophylactic vaccines against Neglected Tropical Diseases (NTDs) in sub-Saharan Africa.
Proposals should carry out early and/or late-stage clinical studies to evaluate the safety, immunogenicity, efficacy in Africa in NTDs. The NTDs in scope of Global health EDCTP3 list are: 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. NTDs out of scope are: Chagas, chromoblastomycosis and other deep mycoses, scabies and other ectoparasites, and snakebite envenoming. Proposals should identify clearly which NTD(s) they are targeting.
Research on development of integrated preventive measures across NTDs is strongly encouraged.
Combined approaches embracing vector control and vaccine development targeting the host/reservoir in the context of One Health are applicable. However, implementation research is out of scope for this topic.
Proposals are to generate clinical data on prophylactic vaccines in the general population and/or, when relevant, include pregnant and lactating women, new-borns, children, adolescents, other vulnerable and neglected populations, and people with co-infections and co-morbidities at risk in SSA. Relevant determining characteristics (sex, gender, age, socio-economic status, etc.) are to be considered. Where possible, collaboration and coordination with the Team Europe Initiative on Manufacturing and Access to Vaccines, medicines and health products (TEI-MAV+) or similar African initiatives is encouraged. The applicants 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.
Proposals should clearly describe the desired target product profile. Applicants need to concisely describe any prior relevant research findings and explain how the proposal builds on available data (including data generated in scope of earlier EDCTP programmes if available). Full details of the development milestones, including specific go/no-go criteria for the implementation of the proposed clinical trial(s) must be included, as well as specific plans for the subsequent regulatory approval process, which should aim at obtaining relevant market authorisation and an access strategy that will allow patients in low-resource settings to access the final product.
The applicants are encouraged to consider new adaptive trial designs and lessons learnt from COVID-19 potentially allowing for shorter development timelines.
Proposals should engage communities and relevant stakeholders, most notably (local) key opinion leaders, researchers, health care professionals, policy makers, public health authorities and end-users. Applicants should provide methodologies for translating research findings into public health practice and policy guidelines and, if relevant, market exploration plans.
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 Franco/Lusophone countries, if possible. Collaboration with other international research groups with relevant experience is very much encouraged. Applicants are also reminded of the expectationof reaching out to organisations in countries with relatively lower research capacities.
All projects funded under this topic are strongly encouraged to participate in networking and joint activities, such as external conferences, workshops or symposiums for an exchange of knowledge, and best practices with external collaborators.
The purpose of this topic is to fund a varied portfolio of projects tackling different diseases. The granting authority will therefore base its funding decision relevant to this topic on the ranking of the proposals taking into account diversity of the respective diseases targeted in the proposals that are graded above thethreshold.