Global collaboration action for the development of TB drugs for therapy and chemoprophylaxis in adults and children in sub-Saharan Africa

Scope

Proposals submitted under this topic should address the following points:

• Advance the clinical development by generating clinical data (Phase IIa trials and beyond) to progress towards registration of new TB drugs, improved or shorter therapeutics TB regimens, chemoprophylaxis and/or more comprehensive interventions combining therapeutics and chemoprophylaxis.

In addition, proposals submitted under this topic are also encouraged to:

• Generate clinical data with a focus on priority populations, including women of childbearing potential and pregnant women, and particularly children, especially for assets in late-stage development.
• Generate clinical data progressing development of new or improved treatment regimens for MDR-TB and XDR-TB.

Pulmonary TB disease, extrapulmonary TB forms, latent TB, DR TB, MDR TB, and XDR TB are considered in scope for this topic. Combination of chemoprophylaxis with vaccines, and combination of chemoprophylaxis with host-directed therapies are in scope as well.

For proposals developing treatment of latent TB, focus should be on individuals with increased risk of progressing to active disease. Proposals can address co-infections or co-morbidities of TB, including HIV/AIDS, but not as the primary objective of the proposal.

Sex/gender differences and the effects of age should be duly taken into account when relevant. For Phase III studies, applicants are encouraged to ensure an adequately statistically powered study allowing for sex/gender and age specific analysis when relevant.

Treatment decision algorithms can be included but not as the primary objective of the proposal.

It is highly important to implement solutions as soon as possible. The granting authority will therefore base its funding decision relevant to this topic on the ranking of the proposals considering a portfolio approach taking into account late stage (phase III) proposals versus valuable more early-stage proposals, all graded above the threshold.

The development of prophylactic vaccines, diagnostics and monoclonal antibodies, Phase I a/b clinical trials of single and/or combination drugs, and implementation research in early phase studies are not in scope.

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, Chemistry, Manufacturing, and Controls (CMC) related activities, etc.).

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.

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

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 and are encouraged to follow guidance provided in the EDCTP Knowledge Hub Research into Policy Toolkit.

Where possible and relevant, 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. 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 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 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.

Post-Exposure Prophylaxis (PEP) research – leprosy focus

In the context of studies on TB post-exposure prophylaxis, the Leprosy Research Initiative will co-fund one or more projects also targeting leprosy post-exposure prophylaxis (PEP), for instance, through integrated implementation of PEP or by evaluating or validating a uniform PEP regimen for both diseases in a clinical trial. The objective and funding of the leprosy-related objective is to be included in the proposal with a total indicative JU budget of 5 million EUR. The selected project(s) will contribute to advancing knowledge and strategies for PEP in the context of TB and leprosy, aligning with broader institutional goals in infectious disease control.

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[[Council Regulation (EU) 2021/2085 of 19 November 2021 establishing the Joint Undertakings under Horizon Europe and repealing Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014]]). 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[[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.]]. 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).