Du 04.02.2026 au 05.02.2026
Evènement d'envergure nationale qui vise à fédérer les entreprises innovantes d’Auvergne-Rhône-Alpes et à mettre en lumière les acteurs clés de l’écosystème technologique et entrepreneurial.
Expected Impact:
Expected impact
The actions funded under this topic should contribute to achieve the reduction of disease burden in SSA through increased international cooperation among researchers and funders, catalyse research synergies, and leverage resources and investment.
Proposals are expected to include the effective in-kind and/or financial contribution of contributing partners, in order to produce more meaningful and significant effects enhancing the impact of the related research activities.
Applicant consortium
The contributions from contributing partners should correspond to the amounts they have committed in the letter of endorsement requesting to become a contributing partner (Article 9 Council Regulation (EU) 2021/2085[1]). Their contributions can consist of financial contributions and/or in-kind contributions. Applicant contributing partners must submit a first draft of the endorsement letter to the Programme Office before the deadline for submission of the second-stage applications[2]. For details on the process on becoming a Global Health EDCTP3 contributing partner, please consult the Guide for contributing partners.
In case of in-kind contribution (even combined with financial contribution), contributing partners become a part of the applicant consortium and participate in the project, as appropriate i.e. as beneficiaries or affiliated entities in the meaning of Article 8 of the Horizon Europe model grant agreement. Also, Global Health EDCTP3 contributing partners can be a country, an international organisation or any public or private legal entity, other than the Global Health EDCTP3 members or their constituent or affiliated entities (please consult the Guide for contributing partners.).
Expected Outcome:
Background
Lower respiratory tract infections (LRTIs) are a leading cause of morbidity and mortality in Sub-Saharan Africa (SSA), particularly among children under five years, the elderly, and immunocompromised individuals. LRTIs is among the top four causes of mortality despite the existence of vaccines against many of their aetiologies suggesting that deaths are largely preventable.
From a prevention perspective, numerous areas require improvement. Awareness about preventive measures such as improved sanitation, better air quality, and reducing indoor air pollution are essential, especially in children. Other vital components for combating the spread of LRTIs are public health education campaigns focusing on hygiene practices, breastfeeding as well as vaccination and the importance of early medical intervention.
Vaccines against pneumococcal disease, influenza, and respiratory syncytial virus (RSV) have proven effective in reducing LRTI-related hospitalizations and deaths in other regions in the world. However, access to vaccines and coverage of these vaccines in SSA is insufficient due to financial and logistical barriers. A single-dose monoclonal antibody (mAb) that provides season-long protection against RSV was approved in EU in 2022. However, several barriers preclude the successful delivery of the mAb in LMICs, including low awareness and accessibility of the mAbs, including the costs of mAbs. The assessment of barriers—financial, logistical, and other—remains a fundamental challenge in achieving optimal vaccine coverage in SSA.
Treatments such as antivirals and low-cost monoclonal antibodies can prevent death once an individual is infected, yet accessibility is to be improved for those in need. To better target the treatment avoiding overuse of antibiotics, it is also important to have rapid diagnostics available, accessible and affordable.
Addressing LRTIs in the region requires targeted multifaceted strategies that consider local challenges such as limited healthcare access, high disease burden other infectious diseases like HIV and malaria, and antimicrobial resistance. Improving access to quality healthcare is critical. Many rural areas in SSA face shortages in healthcare workers and medical supplies, making timely diagnosis and treatment of LRTIs challenging. Strengthening healthcare systems, increasing the availability of essential medications (such as antibiotics for bacterial infections and oxygen therapy for severe cases), and ensuring consistent access to the appropriate vaccines.
Country-level strategies and work plans, coordination of the interventions, critical partners engagement, and promotion of the innovations to overcome the barriers to service delivery are recommended by the Global Action Plan for the Prevention and Control of Pneumonia and Diarrhoea (GAPPD) to governments and partners in order to reduce the mortality from LRTIs (especially in children) and its incidence, following the Protect-Prevent-Treat strategy.
Expected Outcome
The proposals submitted under this topic should aim to deliver results that are directed, tailored towards and contributing to strengthening the capacity of SSA health actors to address LRTIs, associated complications and barriers to effective management.
In addition, proposals are also expected to lead to:
Scope:
Scope
Proposals submitted under this topic should carry out late-stage clinical studies (Phase IIb and after) advancing prevention and treatment of pathogens related to Lower respiratory tract infection (LRTI) by evaluating the safety, immunogenicity, efficacy and/or effectiveness of approved or novel preventive or therapeutic candidates targeting individuals in SSA.
The proposals submitted under this topic should address at least one of the following points:
In addition, the proposals submitted under this topic should include at least one of the following:
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.
[2] The Global Health EDCTP3 Programme Office will ask the applicant contributing partner to revise the letter in case it significantly departs from the template letter published on the Global Health EDCTP3 website or is missing any compulsory elements. The final decision as to acceptance or rejection of a new contributing partner rests with the Global Health EDCTP3 Governing Board.
