Achievements

Free access to all TRANSVAC services including adjuvants, animal models, reference reagents, and global analysis platforms has been provided to 29 high potential vaccine projects, selected through a two-step peer review process, first on scientific excellence, and then on feasibility and impact.  Since July 2012, TRANSVAC has integrated five additional infrastructures that may be accessed on a paid basis.

TRANSVAC activities led to the rationale development of novel vaccine formulations, reference standards, as well as new vaccine candidates (including the compilation of an Investigational Medicinal Product Dossier (IMPD) for the clinical trial application for two vaccine formulations).

Evaluation of vaccine candidates in animal models (mice, humanised (HIS) mice, guinea pigs, pigs and non-human primates) combined with global analyses enabled further understanding of the mechanisms of action of the vaccines.

Research for biomarkers includes an intensive comparative analysis of the Affymetrix and Agilent microarray data, as well as Illumina RNA sequencing data of a Bacillus Calmette–Guérin (BCG) vaccination in phase Ia clinical trial, harmonisation of Standard Operating Procedures (SOPs) for sample, microarray and data analyses, as well as transcriptome mapping of samples from the Human Immunodeficiency Virus (HIV) clinical trial in collaboration with the EuroNeut-41 project.

Harmonisation and standardisation of assays have provided critical data for decision making on choice of formulation, route of administration, vaccination dosages and schedule.  SOPs for immuno-assays for clinical trials are available and validated.

University of Lausanne is providing users with formulation studies, i.e. combination of one antigen with one adjuvant.  Up to date 47 formulation studies have been delivered through TRANSVAC.

To ensure the quality of assays to address vaccine specifications, 19 characterised malaria, HIV and tuberculosis antigens are available to external users. TRANSVAC also provides cell banks of five new cell lines developed for improved growth of adenoviral vectors.

TRANSVAC organised two very successful modular courses in vaccine development, each attended by 15 selected participants.

Six workshops have also been held on subjects as diverse as statistical analyses, animal models, and global analyses.

In collaboration with European vaccine stakeholders, the TRANSVAC consortium prepared a roadmap aimed at securing sustainable vaccine development infrastructures in Europe.  Using a bottom-up approach, the needs and priorities regarding European vaccine R&D were identified through a series of stakeholder consultations and workshops,  and translated into a proposal of establishment of a European Vaccine Research & Development Infrastructure (EVRI).  Representatives of vaccine developers and manufacturers (academic researchers, biotechnology companies, large vaccine development companies, Product Development Partnerships and other European vaccine-related projects), regulatory authorities, international and national policy makers, and funding agencies were very supportive to the project of the establishment of EVRI as presented in the roadmap, and many of them expressed interest to join the initiative.  It has been acknowledged that EVRI replies on numerous needs of European vaccine developers and has a potential to accelerate the development of new or improved vaccines, and shares the vision of the European research agenda Horizon 2020.  The roadmap is now finalised and can be read on the TRANSVAC website.