Vaccines (infectious diseases)

The traditional vaccine development chain starts with the identification of a candidate antigen (fully validated or not), the further developmental steps, which typically represent roadblocks in terms of expertise and infrastructure for most non vaccine development dedicated research groups, is managed by EATRIS through specific activities carried out in the EATRIS partner centres. This scenario represents the minimal entry point for the EATRIS network. Nevertheless, it is envisioned that most candidates will be acquired at far advanced levels of preclinical development, thereby existing different potential entry points in EATRIS (for example starting with (i) vaccine formulation, (ii) preclinical validation, or (iii) clinical development). Where required, support for antigen/prototype re-validation is provided, as well as flanking services (e.g., intellectual property positioning/generation, assessment of freedom to operate, definition of exit strategies/market opportunities).

Analysis and studies are performed to: (i) validate the conceptual and working framework, (ii) assess performance of individual building blocks of the product group, (iii) identify roadblocks, deficits and weak spots, (iv) harmonize and validate the activities performed by the individual centres. The operational plan defines the catalogue of services and support activities provided by different partners or associate partners, and the corresponding time schedule for planned activities and services. The operational plan also encompasses the establishment of a common strategy and tools for (i) harmonization and QA/QC, (ii) internal and external communication, (iii) exchange of data and materials, (iii) selection, assignment and management of projects, and (iv) securing capacity among the individual centres belonging to this product group. Among the extensive list of services are: (i) vaccine formulation, including antigen(s) production (up and downstream), antigen delivery, adjuvantation and galenics; (ii) establishment of in vitro and in vivo assays for preclinical studies (e.g. validated readouts for humoral and cellular immune responses at systemic and mucosal levels, tests to evaluate effector mechanisms, identification of correlates for protection, potency tests, etc.);  (iii) preclinical in vivo validation studies to assess the immunogenicity, efficacy and safety of vaccine products in rodents (e.g. conventional, immunodeficient and humanized mice) and other species (e.g. rats, pigs, non-human primates) up to BSL3 containment, in facilities linked to core immunomonitoring, in vivo imaging, flow cytometry, -omics and histopathology facilities; (iv) GLP certified safety/toxicology; (v) GMP production; (vi) generation, management, coordination and execution of clinical development plans in EATRIS clinical trial centres.