The 2nd Generation Malaria Vaccine Consortium (MVC-2G) will build on the programmatic use of the first-generation Plasmodium falciparum vaccine, R21 with Matrix-M™, and accelerate the clinical development of the leading second-generation multi-stage P. falciparum malaria vaccine comprising R21 and two novel blood-stage components, RH5.1 and R78C, all formulated in Matrix-M™. It will achieve this through a multi-disciplinary workplan, underpinned by international cooperation, that will accelerate the future achievement of the United Nations’ Sustainable Development Goal 3 (SDG3) in sub-Saharan African countries. Its specific objectives are to: 1. Demonstrate safety and superior efficacy against clinical malaria (over R21/MM alone) of the leading second-generation multi-stage vaccine candidate R21+RH5.1+R78C/MM in a Phase 2b trial in 5-17 month old African infants, in a seasonal setting; 2. In parallel, undertake Phase 1b assessment of the second-generation multi-stage vaccine in African infants to define a 3 or 4 dose delivery schedule that is better aligned with EPI and end-user community expectations, aiming for lower cost of goods and to facilitate improved future uptake of a second-generation product; 3. Demonstrate safety and superior efficacy of the multi-stage vaccine (over R21/MM alone) delivered in an optimised age-based schedule in a multi-site Phase 2b trial in African infants in seasonal and perennial settings; 4. Generate evidence to support use of the multi-stage vaccine in future malaria elimination campaigns by assessment of i) efficacy in adults by CHMI, and ii) safety and immunogenicity in older children; 5. Support the next-generation of early-career African scientists, across all partners in the Consortium, by growing a South-South network to facilitate hands on clinical and laboratory training; and 6. Undertake early engagement with regulators in partner countries to facilitate translation and future registration of this multi-stage vaccine.

The ISIDORe consortium, made of the capacities of European ESFRI infrastructures and coordinated networks, proposes to assemble the largest and most diverse research and service providing instrument to study infectious diseases in Europe, from structural biology to clinical trials. Giving scientists access to the whole extent of our state of the art facilities, cutting edge services, advanced equipment and expertise, in an integrated way and with a common goal, will enable or accelerate the generation of new knowledge and intervention tools to ultimately help control SARS CoV 2 in particular, and epidemic prone pathogens in general, while avoiding fragmentation and duplication among European initiatives. Such a global and interdisciplinary approach is meant to allow the implementation of user projects that are larger, more ambitious and more impactful than the EU supported transnational activities that the consortium is used to run. Our proposition is ambitious but achievable in a timely fashion due to the relevance and previous experience of the partners that we have gathered and that have complementary fields of expertise, which addresses the need for an interdisciplinary effort. Leveraging all these existing strengths to develop synergies will create an additional value and enhance Europe capacity for controlling emerging or re emerging and epidemic infectious diseases, starting with the COVID 19 pandemic. Such a global and coordinated approach is consistent with the recommendations of the One Health concept and necessary to make significant contributions to solving complex societal problems like epidemics and pandemics.

Malaria killed about 640 thousand people in 2020, largely young children in Africa. Rapid recent progress has led to two anti-sporozoite vaccine developers planning WHO prequalification applications in 2022. These include the new high efficacy R21/Matrix-M vaccine, to be supplied at the required large scale, and led by partners in this consortium. In parallel, recent progress with transmission-blocking malaria vaccines has led to substantial efficacy in a first direct skin feeding field trial. This opens up the prospect of a two-stage vaccine targeting both sporozoites and sexual-stage parasites that should have a major impact on malaria transmission, thereby enabling regional elimination and ultimate eradication. We propose here to develop such a vaccine assessing both established virus-like particle (VLP) vaccines in potent saponin adjuvants and also exciting new thermostable mRNA vaccines expressing the parasite antigens now showing high efficacy. Importantly, we will adopt new VLP design technologies, e.g. SpyCatcher bonding, that allow bivalent antigen display, to enable a single vaccine to protect against both the Plasmodium falciparum parasite, which causes most deaths, and the more widespread Plasmodium vivax parasite. A lead vaccine candidate will be down-selected based on well-studied pre-clinical efficacy models and induction of functional transmission-blocking antibodies, prior to GMP manufacture and a clinical trial in year 4. The consortium brings together academics, non-profits and a wide range of companies with both leading technologies and access to small and very large scale GMP manufacturing capacity. This programme builds on the recent success of several partners in the R21/Matrix-M programme and aims to accelerate the malaria eradication agenda by providing the first vaccine to tackle both major malaria parasite species, and confer both individual and community protection on the way to eradication.

The silent pandemic of antimicrobial resistance (AMR) is a growing global health crisis with a projected annual mortality rate of 10 million by 2050. Addressing this crisis critically depends on fast, accessible and precise diagnostics to improve detection and prevention of infection and guide antibiotic therapy. Current diagnostics often have insufficient turnaround time or data for timely detection and prevention of outbreaks or precision antibiotic therapy guidance, and accessibility is often limited due to the required infrastructure and expert personnel. To overcome these shortcomings, and address AMR, we are developing a diagnostic based on accelerated whole genome sequencing linked with AI-assisted data analysis. This project termed “DRAIGON” includes a consortium of internationally recognized experts in sequencing platform and assay development, bioinformatics and machine learning, clinical microbiology, infection prevention and control, antibiotic therapy and stewardship, and health economics to jointly develop our in vitro diagnostic solution to target virtually any pathogen-antibiotic combination. We propose to validate and demonstrate the clinical utility of DRAIGON focusing on bloodstream and prosthetic joint infections at five independent sites, including one located in a medium income country representative of areas with a high AMR burden and reduced access to laboratory infrastructure. The diagnostic will be easy to implement and functions as an early detection system to prevent the cross-border spread of pathogens. In rapidly and accurately providing pathogen ID and type, a comprehensive antibiogram, and outbreak cluster information directly from genome data and in a single assay, this innovative high-resolution diagnostic aims to reinforce the global fight against AMR infections and enable the antibiotic stewardship goals of “right antibiotic, at the right dose, for the right patient, and at the right time”.

TRANSVAC-DS project further builds on the outstanding success of EC-funded projects:TRANSVAC1 and TRANSVAC2 and proposes the establishment of a truly sustainable European vaccine infrastructure, which will build upon the lessons learned, activities and achievements of the TRANSVAC1/2 projects. Two infrastructure projects -TRANSVAC1 and TRANSVAC2- have been funded by the European Commission which -through the provision of state-of-the-art scientific-technical vaccine development services, technical training, and innovative vaccine research and development- have provided very significant support to European vaccine researchers and developers. Support has been, and is being provided to the development of human and veterinary prophylactic and therapeutic vaccines. The twenty-five partners in the TRANSVAC-DS consortium that will contribute to the outcome of the project represent ten EU Member States and Associated Countries and include leading organisations from the European vaccine R&D field. The main output of TRANSVAC-DS will be a conceptual design report that will describe in detail the maturity of the concept and be the basis for the establishment of a permanent and sustainable vaccine infrastructure of direct relevance to and benefit for Europe and further afield. As part of the design report, a five-year business plan will be delivered together with an implementation plan that will guide the further establishment of a sustainable European vaccine infrastructure.