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 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 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.