Global collaboration action for prevention and treatment of Lower Respiratory Tract Infections (LRTIs) in sub-Saharan Africa

The HORIZON-JU is a significant grant opportunity under the Horizon Europe program, specifically targeting research on lower respiratory tract infections (LRTIs) in Sub-Saharan Africa. The total budget for this initiative is €33.9 million, with an expected funding of around €8.475 million per grant, aimed at advancing late-stage clinical research and implementation strategies. Eligible applicants include a diverse range of entities such as universities, research organizations, clinical networks, biotech firms, NGOs, and government health agencies, provided they are established in specific eligible countries, which encompass all EU Member States, associated countries, and EDCTP Association member countries in Sub-Saharan Africa. A mandatory multi-partner consortium is required for proposals, involving at least three independent legal entities from different eligible countries. The call encourages projects targeting late-stage clinical trials (Phase IIb and beyond) and implementation research focused on the prevention and treatment of LRTIs. Target pathogens include Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, and others. The initiative aims to address challenges in access, affordability, and health system integration for effective treatments and preventive measures against LRTIs in low-resource settings. This funding opportunity involves a two-stage application process. The first stage requires a concept proposal by March 4, 2026, while the second stage involves a full proposal from successful candidates, due by September 17, 2026. Projects should demonstrate strong local relevance and community engagement, with an emphasis on translating proven interventions from higher-income regions into sustainable solutions for Sub-Saharan Africa. Funding will prioritize proposals that leverage additional financial or in-kind contributions from partners, enhancing the overall impact of the research activities. Successful projects are expected to generate real-world evidence for implementing interventions and improving health outcomes, especially among vulnerable populations such as children and the elderly. The initiative plays a crucial role in strengthening global health equity by specifically addressing the high burden of preventable infectious diseases in low-income regions, thereby fostering international collaboration and resource sharing to develop actionable solutions.

This is a call for proposals under the Horizon Europe program, specifically targeting the Global Health EDCTP3 initiative. The focus is on funding research and innovation actions aimed at preventing and treating Lower Respiratory Tract Infections (LRTIs) in Sub-Saharan Africa (SSA). The call, identified as HORIZON-JU, is a two-stage process with deadlines for the first stage on March 4, 2026, and for the second stage on September 17, 2026. The total budget allocated for this topic is €33,900,000, with an indicative expectation of funding around 4 projects.

The funded actions are expected to contribute to reducing the disease burden in SSA by increasing international cooperation, catalyzing research synergies, and leveraging resources and investment. Proposals should include effective in-kind and/or financial contributions from contributing partners to enhance the impact of research activities.

Applicant consortia must ensure that contributions from contributing partners align with the amounts committed in their letters of endorsement. A first draft of this letter must be submitted to the Programme Office before the second-stage application deadline. Contributions can be financial or in-kind, and contributing partners become part of the applicant consortium, participating as beneficiaries or affiliated entities. Global Health EDCTP3 contributing partners can be countries, international organizations, or any public or private legal entity, excluding Global Health EDCTP3 members or their affiliates.

The background highlights that LRTIs are a major cause of morbidity and mortality in SSA, especially among young children, the elderly, and immunocompromised individuals. Despite the existence of vaccines, access and coverage remain insufficient due to financial and logistical barriers. The call emphasizes the need for multifaceted strategies to address local challenges, improve healthcare access, and ensure the availability of essential medications and vaccines.

The expected outcome of the proposals should strengthen the capacity of SSA health actors to address LRTIs, associated complications, and barriers to effective management. Proposals should also lead to improved LRTI-related outcomes, including reduced mortality and morbidity, and increased access to LRTI interventions in SSA.

The scope of the call requires proposals to conduct late-stage clinical studies (Phase IIb and after) to advance the prevention and treatment of pathogens related to LRTIs. These studies should evaluate the safety, immunogenicity, efficacy, and/or effectiveness of approved or novel preventive or therapeutic candidates targeting individuals in SSA.

Proposals must address at least one of the following:obtaining evidence of immunogenicity, efficacy, safety, or clinical utility on new or existing preventive measures against LRTI pathogens, or obtaining evidence of efficacy, safety, or clinical utility on new or existing treatment measures against LRTI pathogens.

Additionally, proposals should include at least one of the following:obtaining evidence on new or existing preventive health solutions against LRTI for children (including maternal vaccination), improving the coverage, access, scaling-up, and/or availability of preventive and/or treatment measures, implementing existing interventions with demonstrated efficacy and safety in other regions while generating data on real-world effectiveness and cost-effectiveness, or generating clinical data on host-strengthening interventions (e.g., non-specific effects of live attenuated vaccines, pre/probiotics).

Applicants are encouraged to focus on interventions that can be made available to patients quickly, particularly assets in Phase III and interventions already approved in the EU/US. Clinical studies and implementation research of interventions approved in the EU/US should be designed to generate data needed for implementation in SSA.

Pathogens in scope include S. pneumoniae, H. influenzae, S. aureus, K. pneumoniae, Mycoplasma pneumoniae, Chlamydia pneumoniae, human respiratory syncytial virus (RSV), adenovirus, rhinovirus/enterovirus, influenza A/B, human parainfluenza viruses, and human metapneumovirus. Excluded pathogens/diseases are Mycobacterium tuberculosis/Tuberculosis, Cytomegalovirus (CMV), human coronaviruses, and fungi.

Prophylactic vaccines, monoclonal antibodies, and antiviral therapeutics (excluding antibiotics) are within scope. Proposals evaluating monoclonal antibodies should aim to increase accessibility by reducing production costs. Implementation research to enable global access by addressing cost-effectiveness and barriers to access and health system integration is also in scope, with encouragement to consider rural and remote areas and informal urban settlements.

Sex and gender differences and the effects of age should be considered. Phase III studies should ensure adequate statistical power for sex/gender- and age-specific analyses.

Encouraged activities include generating evidence on preventive health solutions against LRTI targeting children, improving uptake, access, scaling-up, and availability of health solutions, implementing existing interventions with demonstrated efficacy and safety in other regions, combining therapeutics with improved oxygen and ventilation support, and capacity building and training activities.

Development of antibiotics and diagnostics is out of scope, although the use of diagnostics as standard of care for differential diagnosis is permissible. Preclinical studies are also out of scope, but preparatory activities during the preclinical phase that enable clinical studies are allowed.

The granting authority will base funding decisions on the ranking of proposals, considering the diversity of targeted diseases and prioritizing late-stage proposals.

Proposals are expected to leverage financial and/or in-kind contributions from contributing partners. Activities should be defined in their entirety, with clear details of components funded by Global Health EDCTP3 and those financed by contributing partners.

Applicants should consider innovations in clinical trial design and research methods and follow WHO guidance for best practices in clinical trials. Collaboration with the AU-EU Health Partnership’s MAV+ hub or similar African initiatives is encouraged, including technology transfer agreements with African counterparts.

Research consortia should have strong representation from SSA countries, including Franco/Lusophone countries, and reach out to organizations in countries with lower research capacities. Proposals should describe the desired Target Product Profile, build on prior research findings, and include development milestones with go/no-go criteria and plans for regulatory approval and access strategies.

Community engagement and stakeholder involvement are essential, with methodologies for translating research findings into public health practice and policy guidelines.

Eligibility conditions include that legal entities must be established in eligible countries, including EU member states, associated countries to Horizon Europe, and constituent states of the EDCTP Association. Consortia must include at least three independent legal entities from different eligible countries, one from a member state or associated country of the EDCTP Association, and one from a sub-Saharan African country that is a member of the EDCTP Association.

If the coordinator is not from an SSA country, a scientific project leader from an SSA country member of the EDCTP Association must be designated. This leader will oversee project scientific governance and leadership, with a dedicated work package and budget.

Evaluation criteria include excellence, impact, and quality and efficiency of implementation. For the second stage of evaluation, specific conditions related to scores and weighting apply, with thresholds for individual criteria and an overall threshold. The evaluation will also consider the production of meaningful effects enhancing research impact through contributions from contributing partners and the leveraging of financial and/or in-kind contributions.

Grants awarded under this topic must include an access plan demonstrating strategies to ensure that developed products and services are affordable, available, and accessible to the public at fair and reasonable conditions. Participants are also subject to additional exploitation obligations to ensure broad availability and accessibility of resulting health technologies and services.

Global Health EDCTP3 may object to the transfer of ownership or exclusive licensing of results for up to four years after the action. Information regarding proposals and evaluation results may be shared with members of the JU Committee of the EDCTP Association.

This funding opportunity aims to support late-stage clinical studies and implementation research to improve the prevention and treatment of LRTIs in Sub-Saharan Africa, with a strong emphasis on collaboration, capacity building, and ensuring access to affordable and effective interventions. It seeks to leverage international cooperation and resources to reduce the burden of LRTIs in the region, particularly among vulnerable populations such as children, the elderly, and immunocompromised individuals. The program encourages innovative approaches to clinical trial design, community engagement, and the translation of research findings into public health policy and practice.

Eligible Applicant Types:The eligible applicant types include legal entities established in specific countries, international European research organisations, and other international organisations whose participation is considered essential. The applicant consortium must include at least three legal entities independent from each other and each established in a different country, where legal entities are eligible to receive funding. It must also include at least one independent legal entity established in a Member State or in an associated country to Horizon Europe that is a member of the EDCTP Association, and at least one independent legal entity established in a sub-Saharan African country that is a member of the EDCTP Association. 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.

Funding Type:The funding type is a grant, specifically a HORIZON Action Grant Budget-Based [HORIZON-AG] under the HORIZON JU Research and Innovation Actions.

Consortium Requirement:A consortium is required. The consortium must include at least three legal entities independent from each other and each established in a different country, where legal entities are eligible to receive funding. It must also include at least one independent legal entity established in a Member State, or in an associated country to Horizon Europe that is a member of the EDCTP Association, and at least one independent legal entity established in a sub-Saharan African country that is a member of the EDCTP Association.

Beneficiary Scope (Geographic Eligibility):The geographic eligibility includes Member States of the European Union and their outermost regions, Overseas Countries and Territories (OCTs) linked to the Member States, countries associated to Horizon Europe, and the constituent states of the EDCTP Association, which are sub-Saharan African countries. Legal entities established in countries not listed above, including low- and middle-income countries that are not members of the EDCTP Association, will be eligible for funding if provided for in the specific call topic conditions, or if their participation is considered essential for implementing the action by the granting authority.

Target Sector:The target sector is health, specifically focusing on the prevention and treatment of Lower Respiratory Tract Infections (LRTIs).

Mentioned Countries:Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Aruba, Bonaire, Curacao, French Polynesia, French Southern and Antarctic Territories, Greenland, New Caledonia, Saba, Saint Barthelemy, Sint Eustatius, Sint Maarten, St. Pierre and Miquelon, Wallis and Futuna Islands, Albania, Armenia, Bosnia and Herzegovina, Canada, Faroe Islands, Georgia, Iceland, Israel, Kosovo, Moldova, Montenegro, New Zealand, North Macedonia, Norway, Serbia, Republic of Korea, Switzerland, Tunisia, Turkey, Ukraine, United Kingdom, Egypt, Morocco, Benin, Burkina Faso, Burundi, Cameroon, Cote d’Ivoire, Democratic Republic of the Congo, Ethiopia, Eswatini, Gabon, The Gambia, Ghana, Guinea-Bissau, Guinea-Conakry, Kenya, Liberia, Malawi, Mali, Mozambique, Namibia, Niger, Nigeria, Republic of the Congo, Rwanda, Senegal, Sierra Leone, Somalia, South Africa, Tanzania, Uganda, Zambia, Zimbabwe.

Project Stage:The project stage is late-stage clinical studies (Phase IIb and after).

Funding Amount:The budget for the topic HORIZON-JU is €33,900,000, with an indicative contribution of around €8,475,000 per grant.

Application Type:The application type is a two-stage open call.

Nature of Support:Beneficiaries will receive money in the form of a grant.

Application Stages:The application process involves two stages.

Success Rates:The success rates are not explicitly stated, but the indicative number of grants is 4 for the topic HORIZON-JU.

Co-funding Requirement:Proposals are expected to include effective in-kind and/or financial contribution from contributing partners. Leveraging of financial and/or in-kind contributions from contributing partners that are equal or greater than the requested JU contribution is taken into consideration during the evaluation.

This opportunity, HORIZON-JU, is a call for proposals under the Horizon Europe program, specifically targeting the prevention and treatment of Lower Respiratory Tract Infections (LRTIs) in sub-Saharan Africa (SSA). The call aims to reduce the disease burden in SSA by fostering international cooperation, catalyzing research synergies, and leveraging resources and investment. It seeks proposals for late-stage clinical studies (Phase IIb and after) that evaluate the safety, immunogenicity, efficacy, and/or effectiveness of approved or novel preventive or therapeutic candidates against LRTIs in SSA. The call encourages applicants to focus on interventions that can be made available to patients as soon as possible, particularly those already approved in the EU or US. The pathogens in scope include S. pneumoniae, H. influenzae, S. aureus, K. pneumoniae, Mycoplasma pneumoniae, Chlamydia pneumoniae, human respiratory syncytial virus (RSV), adenovirus, rhinovirus/enterovirus, influenza A/B, human parainfluenza viruses, and human metapneumovirus. Prophylactic vaccines, monoclonal antibodies, and antiviral therapeutics (excluding antibiotics) are in scope. 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 also encouraged, particularly in rural and remote areas as well as informal urban settlements. The call expects proposals to come from research consortia with a strong representation of institutions and researchers from SSA countries, including involvement of Franco/Lusophone countries, if possible. The total budget for this topic is €33,900,000, with an indicative contribution of around €8,475,000 per grant, and the application process involves two stages.