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.

RSV causes severe disease in the very young and elderly and results in substantial healthcare costs. In the last 4 years, substantial progress has been made in development of products for active and passive immunization against RSV, with 19 products currently in clinical development. In 2017, we were funded by IMI to set up RESCEU project (Grant Agreement number 116019), which is the single largest consortium currently working on RSV and has addressed several of the key evidence gaps to inform the introduction of an RSV vaccine. However, new gaps in evidence have emerged and many key requirements for the introduction of a novel RSV vaccine into national immunisation programmes (not addressed within RESCEU) remain unmet. PROMISE’s vision is to seamlessly build on, exploit, and add value to the significant achievements of RESCEU to prepare for the imminent introduction of an RSV vaccine. Expanding the existing RESCEU network to include 5 new partners, PROMISE comprises of 5 distinct but inter-connected work packages (WPs). WP 1 will conduct epidemiological and cost-effectiveness analyses marshalling data from systematic reviews; national and regional disease registries; surveillance programmes and linked routine healthcare datasets. WP2 will foster a consensus and develop an operational plan for expanded coordinated RSV surveillance and reporting activities; post-licensure monitoring and evaluation of products for RSV immunization across Europe. WP3 will initiate new prospective studies to address key gaps in existing knowledge (RSV disease severity scores, asthma in school age children) and assemble biobanks for biomarker validation. WP4 will validate temporally and at mucosal level biomarkers that were identified in RESCEU adopting state of the art technologies. WPs 1-4 will develop high-quality, sustainable, robust data collection systems that link closely with public health/regulatory bodies/health care providers for informing policy and regulatory processes.

The TRACVAC Consortium will eliminate the global problem of blinding trachoma through the development of a vaccine. Our strategy of the project will eliminate two important bottlenecks for the development of a trachoma vaccine 1) The lack of neutralizing antibody responses to vaccine preparations based on MOMP 2) The challenge of inducing vaccine promoted sustained local ocular IgA. TRACVAC has two main objectives. The first main objective is to generate a vaccine that protect against the bacterial strains causing ocular Chlamydia trachomatis infections. To accomplish this we first select naturally protected individuals from high endemic regions and identify all neutralizing epitopes from the major outer membrane antigen (MOMP) of Chlamydia trachomatis through the unique combination of the B cell cloning and high density array technology. The epitopes will be produced as vaccines through the use of the immuno-repeat technology that is known to increase the quality and quantity of the vaccine promoted response. The second main objective is to develop an immunization protocol for optimal ocular mucosal immunity. To do this we will establish an ocular non-human primate (NHP) challenge model and use this to test different prime boost vaccination strategies for ocular responses and protection against challenge. We will subsequently test the best strategy in a clinical phase I evaluation of a trachoma vaccine based on a immuno-repeat construct targeting serovar B. This will provide early human proof of concept both for the immuno-repeat technology and the prime boost strategy for ocular IgA. In summary, TRACVAC will deliver a final vaccine candidate targeting the main ocular serovars and a vaccine protocol ready to enter a clinical phase I trial. TRACVAC is highly relevant for the topic (Vaccine development for malaria and/or neglected infectious diseases), as the aim is to accelerate vaccine development against the neglected infectious disease Trachoma.

Infectious diseases are a major burden and constant threat to European populations and economies. While barely perceived as a danger not too long ago, a combination of potential rapid spread of novel pathogens across the globe, antibiotics resistance, a come-back of “old” pathogens and persistence of yet to be combated pathogens has raised the demand for effective but safe vaccines. An example of a yet to be combated pathogen is the obligate intracellular bacterium Chlamydia trachomatis. This pathogen is the major cause of sexually transmitted bacterial disease in humans, and poses a world-wide health concern. While responsive to antibiotics, re-infections frequently occur, urging the need for a prophylactic vaccine. Nevertheless, insufficient knowledge on how to vaccinate against intracellular pathogens hampers the development of such vaccines. In the proposed project, 5 academic and 2 private partners will cooperate to educate early stage researchers (ESR) in the diverse aspects of novel vaccine development. ESR will design and construct innovative and safe virus-, bacterium-, and plasmid-based vaccine vectors that induce both cell-mediated and humoral immunity, to control infections with intracellular pathogens. They will test these vaccines and improve their efficacy in preclinical models of C. trachomatis infection, and unravel the cellular and molecular mechanisms underlying the induction of protective immune responses, to uncover possibilities for general vaccine vector optimisation. The end-result will be a new generation of safe vaccine vectors that can be exploited to vaccinate against C. trachomatis, and can be adapted to vaccinate against further intracellular pathogens of choice. Moreover, this project will educate a new generation of scientists that, through the offered, integrated training, will be ready to enter the European task force, in academia or industry, to find creative solutions to future pathogen-imposed challenges.