July 2023
The Final meeting of the TRANSVAC2 project was held in a hybrid form on 19-20 April 2023 in Brussels. Over 50 attendees representing industry, academia, European Commission (EC), project partners and the transnational access (TNA) users were present to review the outcomes of the project and discuss its future perspectives. The meeting created an opportunity to network, discuss vaccinology training and capacity strengthening, and also gave the opportunity of TNA users to present the achievements and lessons learnt through TRANSAVC2.
Success of the project
The TRANSVAC2 project (1 April 2017 - 30 April 2023) was dedicated to construct an efficient and coordinated research and innovation environment, focused on the sustainable institute to provide scientific and technical services to the vaccine research and development (R&D) community. TRANSVAC partners successfully performed joint research activities (JRAs) that continuously enhanced and improved the services offered by the infrastructure. Via these actions, TRANSVAC infrastructure stimulated technological innovation within Europe by fostering research: during the project, uniting 26 partner institutions offered more than 50 scientific services, including animal studies, adjuvant development, immunocorrelate analysis, and regulatory support. At the time of completion, the project has combined to review 103 free-service applications and have approved 74 projects from 16 countries. Over 30% of those projects have been initiated by private sector (for-profit organisations or small- and middle-income enterprises (SMEs)).
In the course of the project, over 400 scientists were able to advance their education and refine their skills through participation in 14-course vaccinology class organised by consortium members. TRANSVAC initiative supported research resulting in the publication of 47 total peer-reviewed articles (16 of which are from 2022 or 2023), including numerous top-tier journal publications.
During the final project meeting, infrastructure users presented their experience with the support provided by TRANSVAC partners and showed the impact it had on the development of their projects. It was highlighted that in many cases TRANSVAC project played a critical role in validation of users’ ideas (some kind of “due diligence” for TNA users). Services delivered by TRANSVAC provided necessary data for taking the critical decision on further development of vaccine candidate. It is important aspect of saving money when going through the “valley of death” in vaccine development. The users appreciated the broader advice they received from TRANSVAC experts, concluding that they have received much more than a simple “service”. In addition to that, TRANSVAC data helped them to leverage their concept and secured fundings for further development of their vaccines.
One of the projects presented at the Final meeting was The Prevent-nCoV-Gap (by Morten Nielse), which aimed to develop a highly effective (>80% protection), rapidly protective (within 2 weeks of vaccination), SARS-CoV-2 sub-unit vaccine (Spike RBD antigen displayed on a Virus-Like Particle), within 11 months in a Phase I/IIa clinical study. The potential increased longevity of the antibody response to the vaccine candidate could reduce the need for frequent booster vaccinations. Multiple TNA services were provided, including formulation/characterisation studies with adjuvants (SSI, HZI), immunogenicity studies in NHPs (BPRC), and scientific advice (EATRIS). Following TNA service provision, the project proceeded to clinical trials and promising results were published in Lancet Microbe. (See: Smit MJ et al., 2003: PMID 36681093)
Similarly, a successful project presented by Charlotte Primard focused on finalising preclinical development of a universal influenza vaccine targeting highly conserved nucleoprotein antigen with the pro-immunogenic oligoDOM® technology. Thanks to promising results obtained via TRANSVAC services provided by VFI (adjuvant formulation), SSI (adjuvant formulation, immunogenicity mice studies) and PHE (ferret challenge study), the vaccine candidate developed by OSIVAX successfully entered clinical phase.
Rip Jaap presented another example of use of TRANSVAC services when discussing the results of the NOVA project. 20Med Therapeutics company is developing nanoparticles (NPs) for nucleic acid delivery. A NP based vaccine candidate with SARS-CoV-2 spike protein mRNA was evaluated in a preclinical in vivo study involving immunogenicity and efficacy studies in mice, provided by SSI. Successful vaccination with 20Med nanoparticles (NP) was shown by detecting antibody levels in blood and a cellular immune response was confirmed by detecting IFN-y levels after stimulation of isolated splenocytes. The obtained results were used for further, ongoing development of the vaccine candidate and the broader applicable nanoparticle technology.
Towards a sustainable European research infrastructure for vaccines
The meeting concluded with a panel discussion about the future need for TRANSVAC as a research infrastructure. Panellists included David Morrow (EATRIS), Dominik Sobczak (ESFRI), Charlotte Vernhes – Sanofi (EFPIA, Vaccines Europe), Ingrid Kromann (CEPI), and Dennis Christensen (CRODA Pharma).
The panellists highlighted that TRANSVAC offers scientific consultancy and advice, which is not provided by commercial contract research organisations (CROs). A future infrastructure should provide different capabilities for assets that could be put to the clinics, would de-risk assets and make bigger pharma companies to invest in vaccine development. While CEPI is looking for similar partnership in Asia and America, TRANSVAC could play such role in Europe.
"The EC is keen on integrating established research infrastructures and it is therefore important for TRANSVAC to find synergies with them." Dominik Sobczak, Deputy Head of Unit at European Commission, DG Research & Innovation
As a key step in this direction, TRANSVAC2 has served as a founding research infrastructure (RI) in ISIDORe. ISIDORe was initiated in February 2022 as a Research and Innovation Action (RIA) under the EC’s Horizon Europe. It brings together 17 European RIs to provide a central, coordinated hub for pandemic preparedness and response. TRANSVAC2 members are continuing to offer TNA services to users under the ISIDORe umbrella beyond the conclusion of TRANSVAC2 as the independent EC Horizon 2020 project. While ISIDORe is currently a 36-month project, TRANSVAC2 members are participating in the sustainability-focused ISIDORe Work Package 6: ISIDORe as a permanent research instrument for the European Research Area (ERA).
TRANSAVC could play a vital role here in alleviating landscape fragmentation. The next step expected by stakeholders would be the mapping of support ecosystem for vaccine developers, to better understand this landscape. Apart from that, an active role of TRANSVAC partners is expected at the level of policy makers in their member states (MS). MS could support this initiative and help in funding, while having great impact on the work programme for research infrastructures.
The majority of TRANSVAC2 partners have also engaged in the Horizon 2020-funded action ‘Design Study for a European Vaccine Infrastructure’ (TRANSVAC-DS), which has been focused on developing sustainable modus operandi for a permanent vaccine RI. Completed by February 2023, this initiative has laid the groundwork for the integrated, sustainable institute by working with project stakeholders to analyse the vaccine landscape, develop and agree to a business plan, and move towards the establishment of a permanent TRANSVAC consortium. Active efforts to establish an infrastructure based on the study conclusions are ongoing.
Learn more by visiting TRANSVAC website: https://www.transvac.org/transvac2
This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement N° 730964.