Vaccines are one of the most successful and cost-effective public health tools for disease prevention. However, their development is time-consuming and complex, requiring a combination of specialised skills and technical capacities not readily available at a single organisation. In order to facilitate access to these skills and capacities, and to promote collaborations in the European vaccine landscape - aiming thereby to accelerate the development of safe, effective and affordable vaccines - the EC, in the context of the Horizon 2020 Framework Programme, has recently funded “TRANSVAC2”, a European vaccine research and development (R&D) infrastructure.
TRANSVAC2 builds upon the success of TRANSVAC, the European Network of Vaccine Research and Development funded under the EC´s previous Framework Programme (FP7). TRANSVAC made significant contributions to the European vaccine development landscape, providing scientific-technical services to more than 29 vaccine projects and developing a roadmap for the establishment of a sustainable European vaccine R&D.
This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement N° 730964.
TRANSVAC supports innovation for both prophylactic and therapeutic vaccine development. High quality technical services across four different service platforms are offered: Technology (for process development and GMP production), Immunocorrelates & Systems Biology, Animal models, and support for Clinical Trials.
Academic and non-academic research groups, including SMEs, can apply to benefit from the expertise, reagents, and facilities offered by TRANSVAC2 to accelerate the development of their vaccines.
TRANSVAC will further accelerate vaccine development by developing and applying cutting-edge technologies to address critical issues in modern vaccine development and thereby increase the quality of services provided. In addition, TRANSVAC will continue to establish a sustainable vaccine development infrastructure in Europe.
TRANSVAC also offers training courses to provide fundamental and advanced knowledge on a wide-range of vaccine development-related topics. Training modules will be harmonised with existing European vaccinology courses, aiming to complement existing infrastructures and activities. TRANSVAC will therefore centralise and expand the training opportunities available to the European vaccine community.
With this comprehensive approach, TRANSVAC2 functions as a leverage and innovation catalyst between all stakeholders involved in vaccine R&D in Europe, and contributes to the development of effective products to address European and global health challenges. This reinforces the European leadership in controlling the burden and spread of diseases, and the economic assets represented by vaccine developers in Europe.
The TRANSVAC2 organisational structure includes three types of consortium bodies: strategic bodies, implementation bodies and advisory bodies.
Research Activities (JRA)
TRANSVAC’s joint research activities (JRAs) aim to address current major gaps in vaccine development knowledge and are designed to feed directly into and to support the TNA activities.
The TRANSVAC research activities focus heavily on improving adjuvants, predictive assays, systems biology and animal models.
The rational use of adjuvants will be studied in detail, as very often researchers use a “shotgun” approach with adjuvants, testing entire panels with their antigens in the search for improved immune responses.
Adjuvant research activities will aim to:
Develop stable formulations (and combinations thereof) for the focused and rational improvement of specific aspects of the immune response, as required in light of the unformulated antigen’s in vivo immunoprofile.
Predictive assay research will aim to:
Develop assays that are of validated and reproducible benefit to vaccine development. This will be underpinned and supported by systems biology research, leading to the improvement of predictability of assays.
Systems biology research will aim to:
Identify and validate mathematical models that can accurately predict interactions between immune system components in relation to vaccination;
Develop state-of-the-art methods for the structural and functional analysis of vaccine candidates;
Support the activities to improve the predictability of animal models.
As the lack of a credible and validated animal model is reality for the majority of diseases, this represents a major roadblock in rapidly and reliably advancing vaccine candidates through the pipeline. In parallel, several animal models currently exist that are presumed to be credible predictors of vaccine efficacy in humans, but which have only very limited correlation with human protection, and which are used simply because no other alternatives exist.
Animal models research will aim to:
Improve the predictive value of animal models for vaccine evaluation;
Provide consultancy on the selection of appropriate models;
Develop innovative approaches to characterise in vivo antigen behaviour and host responses whilst reducing animal use.
Regional, national, and European regulators play a critical role in guaranteeing vaccine quality, and act as facilitators by providing scientific advice to vaccine researchers. It is therefore essential that “regulatory science” is part of the process of innovation, in order to fulfil its role in the assessment of new technologies and new concepts.
The regulatory activities in TRANSVAC will address two goals:
(i) to offer advice to scientists;
(ii) to stimulate business intelligence, thus identifying scientific areas that should be recommended for further development, ensuring that regulators can gain access to the data needed for them to make rational and science-based decisions.
In order to achieve the first goal, the regulatory work package will offer user-friendly access to a database compiling current information on the regulatory and ethical requirements for clinical trials and for marketing authorisation related to prophylactic and therapeutic vaccines. The second objective will be to provide customised advice to the other work packages in the consortium, to users through specific consultancy agreements, and to regulators through policy change proposals. The regulatory work package will provide consensus science-based suggestions for the adaptation of regulatory requirements.
The second goal will therefore be addressed by the whole consortium, during the assessment of proposals for TNA services as well as breakthroughs in the innovation and in the joint research work packages. The role of TRANSVAC will be to unite relevant experts and regulators, to address emerging issues, and adopt new approaches through specific consultation workshops and meetings.