TRANSVAC2 is the follow-up project to its successful predecessor project TRANSVAC, the European Network of Vaccine Research and Development funded under FP7. The TRANSVAC2 consortium comprises a comprehensive collection of leading European institutions that propose to further advance with the previous initiative towards the establishment of a fully operational and sustainable European vaccine R&D infrastructure. TRANSVAC2 will support innovation for both prophylactic and therapeutic vaccine development based on a disease-overarching and one-health approach, thereby optimising the knowledge and expertise gained during the development of both human and animal vaccines. This will be achieved by bridging the translational gap in biomedical research, and by supporting cooperation between public vaccine R&D institutions of excellence, related initiatives and networks in Europe, and industrial partners. TRANSVAC2 will complement and integrate with existing European research infrastructures in both the public and private sectors. TRANSVAC2 will function as leverage and innovation catalyst between all stakeholders involved in vaccine R&D in Europe and -by providing integrated and overarching vaccine R&D services- will contribute to the development of effective products to address European and global health challenges, to controlling the burden and spread of infectious diseases, and reinforce the economic assets represented by vaccine developers in Europe. The impact of TRANSVAC2 will be maximised by two external advisory bodies. An independent Scientific & Ethics Advisory Committee will provide recommendations surrounding scientific-technical and ethical issues, whereas the coordination of TRANSVAC2 with other related initiatives and the further promotion of the long-term stability of a European vaccine R&D infrastructure will be supported by a Board of Stakeholders comprising representatives of policy and decision makers, industry associations and European infrastructures.

The availability of effective malaria vaccines is a historic landmark, “a breakthrough for science, child health and malaria control” that “could save tens of thousands of young lives each year” [WHO 2021]. But substantial implementation challenges need to be addressed to realise this potential. In many areas where malaria vaccines will soon be introduced, EPI coverage is suboptimal, especially in the second year of life. Introduction of malaria vaccines is also an opportunity to strengthen delivery of basic vaccines because a) additional immunisation visits will be required to administer 3 doses of malaria vaccine between the ages of 5 and 9 months and a fourth dose at about 2 years, and b) in areas with highly seasonal malaria, annual intensification of vaccine delivery may be advantageous to optimize malaria impact, both providing opportunities for catch-up of other vaccines, and c) recognition of the importance of malaria may lead to be less mistrust of malaria vaccines, as observed during pilot implementations; such positive attitudes could be leveraged to promote vaccination in general. The purpose of this project is to support national immunization and malaria programmes in 14 countries in West and Central Africa with highly seasonal malaria, to optimize delivery and uptake of malaria vaccines, and to exploit the opportunities to strengthen delivery of other vaccines. This will be achieved through a programme of implementation research, adapting delivery approaches to local situations, and sharing information about what works best. The project, which builds on a network of 13 countries that was established through the EDCTP-funded OPT-SMC project, coordinated by the University of Thiès in Senegal, the LIH, TDR, LSHTM, CAPM, MMV and WHO, will provide grants and technical assistance to national programmes to enable them to monitor vaccine introduction and identify barriers to uptake, and develop, implement, and evaluate strategies to address these barriers.

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”.

Malaria remains a serious health concern worldwide, with P. falciparum considered one of the deadliest human parasites. Yet, the currently approved vaccine against malaria (RTS,S/AS01) offers limited protection due to challenges in vaccine development. Using current advances made in understanding immunity to address some of the existing challenges, this proposal aims to develop a more efficacious vaccine against P. falciparum by targeting multiple developmentalstages(sporozoite, liver and blood-stage). In this project, combinations of 1) highly promising whole parasite vaccination approach targeting the liver (late-arresting GAP), 2) RTS,S (provided by GSK) and 3) mRNA versions of clinically evaluated and partially protective blood stage vaccine candidates (Rh5, AMA1-DiCo [sporozoite and blood stage]) will be evaluated in preclinical and small-scale human trials to discern the optimal combination for further clinical investigations. To inform a rational design of future vaccine candidates, CAPTIVATE will analyse the vaccine-induced immune response to acquire a full understanding of malaria protective immunity and develop an advanced immunology in-silico platform. While immunity to blood stage malaria is relatively well understood, the mechanisms of adaptive protective immunity for pre-erythrocytic malaria vaccine candidates are less well-established. CAPTIVATE addresses this critical knowledge gap by combining state-of-the-art preclinical and clinical (CHMI) in vivo malaria vaccine efficacy models with an innovative in-silico platform comprising TCR/VDJ sequencing and artificial intelligence predictions, to identify such mechanisms. CAPTIVATE assembles a unique combination of European experts in their respective fields (malaria modelling in primates, clinical vaccine testing, in-silico modelling of immune responses, innovative omics approaches) in an integrated interdisciplinary approach aimed at bringing the next generation malaria vaccines to the clinic.

The ongoing COVID-19 pandemic creates an unprecedented burden worldwide. Vaccine-induced immunity is the only promising solution. There is continued need for phase 2 & 3 vaccine trials to reach long-term, large-scale immunity of the entire European population. VACCELERATE will be the pan-European backbone accelerating phase 2 & 3 COVID-19 vaccine trials. The overall objective of VACCELERATE is to connect all European stakeholders involved in vaccine development to provide a pan-European platform for clinical trial design and conduct. VACCELERATE constitutes the rapid response single entry-point to stakeholders from public health authorities to vaccine developers, to address respective needs and kick-start specifically phase 2 & 3 vaccine trials. VACCELERATE conducts capacity mapping of clinical trial and laboratory sites to identify suitable sites for individual phase 2 & 3 vaccine trials. Capacity building via training will increase quality in sites across Europe. Volunteer registries facilitate patient recruitment. Access to laboratory sites and a standardised set of assays essential for clinical phase 2 & 3 trials is provided. A harmonised European approach to vaccine trials is enabled by aligning educational standards, coordination of laboratory support and providing standardised assays and trial protocols. Harmonised data collection, open data sharing and pooling of data for stronger analysis enables data standardisation. VACCELERATE offers solutions for characteristic vaccine development issues during pandemics by closing gaps in public health knowledge and improving knowledge transfer. VACCELERATE amalgamates the vast but scattered expertise across Europe into one network to deliver strategic scientific leadership and guidance on vaccine trials in Europe. Beyond the COVID-19 pandemic, it will be an established pandemic preparedness network, ready to face emerging future pandemics, as well as a pivot in Europe?s capacity to develop vaccines.