Accelerating the development of prophylactic vaccines against Neglected Tropical Diseases (NTDs) in sub-Saharan Africa

Opened

Programme Category

EU Competitive Programmes

Programme Name

Global Health EDCTP3 Joint Undertaking

Programme Description

The Global Health EDCTP3 Joint Undertaking (GH EDCTP3) builds on the first and second European and Developing Countries Clinical Trials Partnership programmes. This new joint undertaking (JU) is a partnership between the EU and the EDCTP Association, whose members are several European and African countries. The partnership will deliver new solutions for reducing the burden of infectious diseases in SSA and strengthen research capacities to prepare and respond to re-emerging infectious diseases in this region and across the world.

Programme Details

Identifier Code

HORIZON-JU-GH-EDCTP3-2025-01-NTD-03-two-stage

Call

Accelerating the development of prophylactic vaccines against Neglected Tropical Diseases (NTDs) in sub-Saharan Africa

Summary

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.

The objective of the topic is to progress the development of prophylactic vaccines against Neglected Tropical Diseases (NTDs) in sub-Saharan Africa.

Detailed Call Description

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 expectation of 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.

Call Total Budget

€45.900.000

Financing percentage by EU or other bodies / Level of Subsidy or Loan

Expected EU contribution per project: €15.300.000

 

Thematic Categories

  • Health
  • Public Administration
  • Research, Technological Development and Innovation

Eligibility for Participation

  • Central Government
  • International Organisations
  • Legal Entities
  • Local Authorities
  • Other Beneficiaries
  • Private Bodies
  • Researchers/Research Centers/Institutions
  • State-owned Enterprises

Call Opening Date

30/01/2025

Call Closing Date

02/09/2025

EU Contact Point

EDCTP – Europe Office
Postal and visiting address: Anna van Saksenlaan 51, 2593 HW The Hague, The Netherlands
Telephone: +31 70 344 0880

EDCTP – Africa Office
Postal address: P.O. Box 19070, Tygerberg 7505, Cape Town, South Africa
Visiting address: Francie van Zijl Drive, Parowvallei 7505, Cape Town, South Africa
Telephone: +27 21 938 0690
Fax: +27 21 938 0569

Contact Form in the website