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Enabling the WHO-Roadmap 2030

Project description

Tackling neglected tropical diseases through adaptive clinical trials

Neglected tropical diseases (NTDs) are a group of parasitic and bacterial infections affecting over one billion people worldwide, mostly in low-income areas. Sub-Saharan Africa (SSA) is disproportionately affected, with around 40 % of the global NTD burden. The EU-funded eWHORM project aims to improve clinical research infrastructure and establish an adaptive clinical trial platform. Specifically, it will develop a drug that acts safely on multiple helminth species. It will assess the efficacy of the cheap and freely-accessible pan-nematode drug oxfendazole in an adaptive clinical trial against onchocerciasis, loiasis, mansonellosis, and trichuriasis. The project’s interdisciplinary partnership between eight countries will ensure sustainable capacity building within SSA countries and a patient-centric approach to precision mapping for elimination programmes.

Objective

We will establish for the first time in NTDs an adaptive clinical trial platform and improve clinical research infrastructure in four SSA countries. A drug acting safely on multiple helminths species would be a major leap to tackle NTDs and enable the WHO RoadMap (eWHORM). The cheap and freely-accessible pan-nematode drug oxfendazole (OXF) has such potential. Given the limited portfolio of anthelmintic drug candidates, eWHORM will assess its efficacy in an adaptive clinical trial for simultaneous evaluation against onchocerciasis, loiasis, mansonellosis and trichuriasis. Thus not only the largest group of NTDs, but also diseases that are not (yet) listed will be adressed. This design significantly reduces patient numbers, development time-frames and enables treatment of co-infections. Combined with our highly sensitive molecular tests, we provide a patient-centric approach providing tools for targeted treatment (test and treat) and precision mapping for elimination programs. Strengthening of early career scientists in SSA in all aspects of clinical trial conduct and research including data management, simulation and statistical analysis, will be fostered by introducing a master and PhD program, a mentorship program as well as several webinars. An open-source virtual training and assessment tool for diagnosis of NTDs will complement the knowledge transfer to remote areas in SSA. The consortium encompasses an interdisciplinary partnership from eight different countries (Germany, the Netherlands, Austria, Switzerland, Cameroon, Gabon, Tanzania, and DRC). Each group brings unique knowhow and recognized complementary experience to the project to ensure sustainable capacity building within SSA countries. Through joint development of – and training in – modern, regulatory clinical trial conduct, adaptive clinical trial design and state-of-the-art diagnostics, we will strengthen SSA researchers and clinicians to respond to persisting and future health challenges.

Keywords

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Programme(s)

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Topic(s)

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Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) HORIZON-JU-GH-EDCTP3-2022-01

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Coordinator

UNIVERSITATSKLINIKUM BONN
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 1 596 717,50
Address
VENUSBERG-CAMPUS 1
53127 Bonn
Germany

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Region
Nordrhein-Westfalen Köln Bonn, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 1 596 717,50

Participants (7)

Partners (2)

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