HORIZON EUROPE
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Expected Impact:Expected impact
The actions funded under this topic should contribute to increased international cooperation among researchers and funders, catalyse research synergies, and leverage resources and investments in order to achieve the reduction of disease burden in SSA through the development of vaccines.
Proposals are expected to include the effective in-kind and/or financial contribution of contributing partners, in order to produce meaningful and significant effects enhancing the impact of the related researchactivities.
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). Their contributions can consist of financial contributions and/or in-kind contributions. Applicant contributing partners must submit the endorsement letter for approval by the Global Health EDCTP3 Governing Board before the deadline for submission of the second-stage applications. It is recommended that the draft letter is submitted to the Global Health EDCTP3 Pro...
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Expected Impact:Expected impact
The actions funded under this topic should contribute to increased international cooperation among researchers and funders, catalyse research synergies, and leverage resources and investments in order to achieve the reduction of disease burden in SSA through the development of vaccines.
Proposals are expected to include the effective in-kind and/or financial contribution of contributing partners, in order to produce meaningful and significant effects enhancing the impact of the related researchactivities.
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). Their contributions can consist of financial contributions and/or in-kind contributions. Applicant contributing partners must submit the endorsement letter for approval by the Global Health EDCTP3 Governing Board before the deadline for submission of the second-stage applications. It is recommended that the draft letter is submitted to the Global Health EDCTP3 Programme Office sufficiently ahead of deadline for submission of proposals to allow the review[1].
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 orAffiliated entities in the meaning of Article 8 of the Horizon Europe model grant agreement.
[1] The Global Health 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 JU website or is missing any compulsory elements. The preliminary assessment by the Programme Office does not consider the merits of the application. The final decision as to acceptance or rejection of a new contributing partner rests with the Global Health EDCTP3 JU Governing Board
Expected Outcome:Background
Tuberculosis (TB) is a preventable and usually curable disease. Yet in 2022, TB was the world’s second leading cause of death from a single infectious agent, after coronavirus disease (COVID-19), and caused almost twice as many deaths as HIV/AIDS. More than 10 million people continue to fall ill with TB every year. Moreover, adolescents and adults account for over 80% of the TB burden and are the main source of transmission, including to children.
The main health care intervention available to reduce the risk of TB infection progressing to active TB disease, is TB preventive treatment. Other preventive interventions include vaccination of children with the bacille Calmette-Guérin (BCG) vaccine, which can confer protection, especially from severe forms of TB in children. Whereas TB vaccination is the most cost-effective and efficient approach in tackling this challenge, no new vaccines for prevention of all forms of TB have been licensed for over 100 years. BCG offers inconsistent protection against TB in adolescents and adults. Several TB vaccines are currently in clinical development, including some in phase III.
As part of the 2023 United Nations (UN) Declaration on TB, world leaders adopted a historical declaration with ambitious commitments to universal access to TB services in both high and low burden countries, with time-bound targets of reaching, with health services, at least 90% of people with or at risk of TB between 2023 and 2027, to increased investments in the TB response (including for research and innovation), and to fast-tracking the development and availability of new tools to prevent, diagnose and treat TB, particularly new TB vaccines. This includes USD 5 billion by 2027 for TB research and innovation, especially to high- burden countries. The Global Fund to Fight AIDS, TB and Malaria remains the main international donor (USD 9,2 billion for the three epidemics) and the Gates foundation the main contributor from the non- governmental sector. Among others, the other main funders include: Biofabri, company X, EDCTP, European Commission, Germany Federal Ministry of Education and Research, Global Affairs Canada, Indian Council of Medical Research, Innovative Health Initiative, L’Initiative, Novo Nordisk Foundation, Open Philanthropy, Otsuka Pharmaceutical, Oxford Immunotec, Unitaid, US Agency for International Development, US Centres for Disease Control and Prevention, US National Institutes of Health and Wellcome Trust.
This investment will build on and complement the previous EDCTP2 investments which involved at least two TB vaccine candidates in late-stage clinical development and played a pivotal role in the development of the Global TB Vaccine R&D roadmap. This call for proposals is part of the implementation of this roadmap that prioritises diversifying the TB vaccines pipeline and accelerating clinical development ofvaccine candidates with an end-to-end approach to maximise public health impact.
Expected Outcome
This topic aims at supporting activities that contribute to one or several of the expected impacts for this call. To that end, proposals submitted under this topic should aim for delivering results that are directed, tailoredtowards and contributing to at least two of the following expected outcomes, with the first being mandatory:
Obtain evidence of immunogenicity, efficacy, safety or clinical utility on vaccine candidates under development and licensed vaccine(s);Generate clinical data on TB prophylactic vaccines serving adolescents and adults, and including where appropriate pregnant and lactating women, new-borns, children, other vulnerable and neglected populations, and people with co-infections and co-morbidities at risk in SSA;Contribute to the data package related to immunisation/vaccination enabling public health authorities and policy makers to recommend on vaccination strategies, publish updated or new evidence-based clinical guidelines and best practices or design tailor-made TB policies targeting SSA. Scope:Scope
The objective of the topic is to progress the development of vaccine candidates under development and licensed TB vaccines, especially targeting the population in low-middle countries, particularly in SSA.
Proposals should carry out early and/or late-stage clinical studies to evaluate the safety, immunogenicity, efficacy and/or clinical utility on vaccine candidates under development and licensed vaccines in SSA. Proposals are to generate clinical data on TB prophylactic vaccines in adults and adolescents, and including where appropriate, pregnant and lactating women, new-borns, children, other vulnerable and neglected populations, and people with co-infections and co-morbidities at risk in SSA when relevant. A comparative arm with BCG and an assessment of overall health outcomes may be included when appropriate.
Implementation research is not in the scope of this topic.
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. Proposals should carefully consider WHO's Product Profile Characteristics and/or Evidence Considerations for Vaccine Policy framework. 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.
The applicants are encouraged to consider new adaptive trial designs and lessons learnt from COVID-19 potentially allowing for shorter development timelines.
Proposals should engage communities and relevant stakeholders, most notably (local) key opinion leaders, researchers or clinical Investigators, 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.
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. The applicants could show, for example, willingness to enter into technology transfer agreements with their 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 affordableproducts 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 sub-Saharan African countries, including active participation of Franco/Lusophone countries, if possible. Collaboration with other international research groups with relevant experience is very much encouraged. Applicants are also reminded of the expectation of reaching out to institutions/organisations in countries with high disease burden but with relatively lower research capacities.
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Características del consorcio
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La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Características del Proyecto
Características de la financiación
Para el presupuesto subvencionable la intensidad de la ayuda en formato fondo perdido podrá alcanzar como minimo un 100%.
Información adicional de la convocatoria
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