Proposals submitted under this topic are expected to advance the clinical development of existing and new antimalarial candidates.

The development of prophylactic vaccines and monoclonal antibodies is not in scope for this topic.

Proposals should carry out early and/or late-stage clinical studies to evaluate the safety, efficacy and effectiveness of new combinations of currently approved or novel therapeutic candidates targeting individuals in SSA. Proposals are to generate clinical data targeting children, pregnant women, and immune-compromised individuals or adolescents living in high transmission regions as relevant. Interventions may target both P. Falciparum and/ or P. Vivax. Promising transmission blocking agents may be included as part of combination therapies.

To this end, proposals submitted under this call topic should address at least two of the following, with the first being mandatory:

• Clinical trials from Phase 2a onwards, to progress the development of new combinations of currently approved or novel therapeutic candidates;
• Long term effectiveness studies through aligned primary endpoints where possible;
• Generation of pharmacovigilance data on currently registered therapeutics or candidates in late- stage efficacy trials;
• Evidence on resistance to current treatments including combined therapies as secondary outcome.

Proposals submitted against this topic are expected to leverage financial and/or in-kind contribution from contributing partners. Proposals should define the activities of their project in its entirety, including details of the component(s) for which Global Health EDCTP3 JU funding is requested and the component(s) that are to be financed by contributing partners.

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. 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.

Applicants are reminded of the expectation that proposals should come from research consortia with a strong representation of institutions and researchers from SSA countries, including involvement of Franco/Lusophone countries, if possible. Applicants are also reminded of the expectation of reaching out to organisations in countries with relatively lower research capacities.

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.

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.