The proposals submitted under this topic should address at least one of the following points:

1. Obtain evidence of immunogenicity, efficacy, safety or clinical utility on new or existing preventive measures against LRTI pathogens listed below, or
2. Obtain evidence of efficacy, safety or clinical utility on new or existing treatment measures against LRTI pathogens listed below.

In addition, the proposals submitted under this topic should include at least one of the following:

1. Obtain evidence on new or existing preventive health solutions against LRTI for children (including maternal vaccination).
2. Improvement of preventive and/or treatment measure’s coverage, access, scaling-up and/or availability.
3. Implementation of existing intervention with demonstrated efficacy and safety in other regions, with generation of data on real-world effectiveness and cost-effectiveness.
4. Generate clinical data on host-strengthening interventions (non-specific effects of live attenuated vaccines, pre/probiotics, and/or other non-pharmaceutical interventions).

Applicants are encouraged to focus on interventions that could become available to patients as soon as possible, as assets in phase III and interventions already approved in EU/US.

Clinical studies and implementation research if any, of interventions already approved in EU and/or US should be designed fit-for-purpose, generating the data as needed to ensure the implementation of interventions in SSA.

Pathogens in scope of the topic are: S. pneumoniae, H. influenzae, S. aureus, and K. pneumoniae, Mycoplasma pneumoniae, Chlamydia pneumoniae, human respiratory syncytial virus (RSV), adenovirus, rhinovirus/enterovirus, influenza A/B, human parainfluenza viruses, and human metapneumovirus. Pathogens/disease that are considered out of scope are Mycobacterium tuberculosis/Tuberculosis, Cytomegalovirus (CMV), human coronaviruses and fungi.

Prophylactic vaccines, monoclonal antibodies and antiviral therapeutics (excluding antibiotics) are in scope. Proposals evaluating monoclonal antibodies should aim to increase accessibility by reducing the cost of production enabling a lower purchase price.

Implementation research to enable global access of the interventions by addressing cost effectiveness analysis and/or assessing barriers for access and health system integration, is in scope. In addition, proposals including implementation research are encouraged to consider rural and remote areas as well as informal urban settlements.

Sex and gender differences and the effects of age should be duly taken into account when relevant. For Phase III studies, applicants are encouraged to ensure adequate statistical power for sex/gender- and age-specific analyses as relevant.

Activities which are encouraged to be included in the proposals are: generating evidence on new or existing preventive health solutions against LRTI targeting specifically children, activities that lead to the improvement of the uptake, access, scaling-up and/or availability of the health solutions, implementation of existing intervention with demonstrated efficacy and safety in other regions, with generation of data on real-world effectiveness and cost-effectiveness, activities that combines therapeutics with the improvement of oxygen and ventilation support when relevant, capacity building and training activities focusing on effective use of treatment and prevention strategies.

Development of antibiotics and diagnostics are considered out of scope. However, use of diagnostics as standard of care addressing differential diagnosis is permissible.

Preclinical studies are considered out of scope of the topic.

However, preparatory activities conducted during the preclinical phase can be considered in scope if they enable the conduct of the clinical study/ies in scope (these activities include but are not limited to protocol writing, development/evaluation of laboratory tests, CMC related activities, etc.).

The purpose of this topic is to fund a varied portfolio of LRTI related projects. In addition, it is highly important to implement solutions as soon as possible, in particularly for health solutions which have shown improved health outcomes in other regions of the world as EU and US. 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 the threshold as well as taking into account late-stage proposals, for proposals that are graded above the threshold.

For all Global Collaboration Actions such as this topic, proposals submitted 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 funding is requested and the component(s) that are to be financed by contributing partners. Each contribution should be well described and budgeted in each proposal, so that the activities and related costs that are covered by the in-kind or financial contribution(s) are clearly identified.

The applicants are encouraged to consider the latest innovations and advances in the clinical trial design and research methods in order to evaluate promising interventions allowing shorter development timings. Applicants are also encouraged to follow the WHO Guidance for best practices for clinical trials.

Where possible, collaboration and coordination with the AU-EU Health Partnership’s Manufacturing and Access to Vaccines, medicines and health technologies (MAV+) hub 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 and are encouraged to follow guidance provided in the EDCTP Knowledge Hub Research into Policy Toolkit.