Global collaboration action for the development of vaccines for reducing the disease burden of Tuberculosis in sub-Saharan Africa

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.

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