The high impact project Advanced Immunization Technologies (ADITEC) started as an ambitious €30 million EU project to boost vaccine research. During the 5 year term of the project, the goal is to develop novel immunization technologies for the next generation of human vaccines. Already in the first year, a lot has been achieved in developing immunization technologies, animal models and human immunology.

Background
Recent progress in science and technology now makes it possible to achieve what was previously deemed impossible. Genomics, structure-based design and optimization of immunogens, small molecule adjuvants targeting specific receptors and systems biology, together with sophisticated assays to monitor the immune response are transforming the old field of vaccinology into one of the most dynamic of this century and are opening the door to fight those diseases that so far have been reluctant to vaccine development. We now have the means to move beyond the “old” empirical approach to vaccine development, where we often did not fully understanding the mechanisms behind the a vaccine’s protective abilities, and use cutting-edge technologies to better understand licensed and experimental vaccines.

Thanks to these new technologies, the time for vaccine candidate discovery has become shorter in the past decades, however the full amount of time needed for has increased  vaccine development, due to the size and complexity of clinical trials. For the next decade, we will focus on shortening the time required for vaccine development via innovative trial design and systems biology. With systems biology we can identify novel biomarkers for safety and efficacy and also improve the understanding of correlates of protection to infection. The project focusses on immunization technologies, animal models and human immunology. In these fields there are already the first results. By the conclusion of the project, ADITEC aims to:

1. Develop advanced immunization technologies: adjuvants, vectors, formulations and delivery devices
2. Select candidates, routes of immunization and prime-boost combinations in animal models
3. Assess the impact of host factors in response to vaccination
4. Develop concepts and tools from human immunization :
   • Molecular signature of immunity, immunogenicity, and safety
   • Profile of  immune response to defined adjuvants and prime-boost strategies
   • Alternative routes of immunization
   • Transcriptomics and immune response: enteric infection versus prophylactic immunization
   • Phase I clinical trials of novel immunization technologies developed by the consortium
5. Develop concepts and tools to address regulatory and ethical issues posed by novel immunization technologies
6. Create an internationally recognized training program for translational immunology and vaccinology.

Immunization technologies
Within the ADITEC project, 2 modelpathogen were selected before the project started: Tuberculosis;(Ag85B and ESAT-6) and Influenza;(HA). During the first year of the project, a third was selected: Chlamydia (MOMP) . In the first year, several antigens and adjuvants have been exchanged and common standard protocols have been established. Adjuvants with ADITEC prototype antigens have been formulated and the first pre-clinical testing has been done. Recombinant vaccine vectors expressing ADITEC prototype antigens have been constructed and progress in the development of second generation adjuvants and vectors has been achieved.

Animal models
In the first year of the ADITEC project, challenge models have been established. Furthermore correlates of protection, immunogenicity at extreme of age, and T-cell of priming and prime-boost strategies have been studied.

Human immunology
The first Phase I clinical trial with novel technology was selected: Shigella outer membrane particles. Biomarkers of immunogenicity were studied and a system biology analysis of TIV vaccination was made. Furthermore 4 clinical studies were initiated, 5 studies are in the protocol development phase and 3 are under planning.Other results Besides the research part of the project, ADITEC also addresses regulatory and ethical issues. The development of enabling regulatory frameworks has started, as well as the standardisation of novel technologies. We are happy that with Dr. Cornelia Exner (animal studies) and Dr. Zarifah Reed (human studies) the project ethics committee has been nominated.

ADITEC has the ambition to create an internationally recognized training program for translational immunology and vaccinology. The first course (Advanced course of Vaccinology) was already completed, and the 2013 course is scheduled for 6 to 17 May .

More information can be found in the presentation of Donata Medaglini.