ADITEC’s second year progress
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. In the first two years, a lot has been achieved in developing immunization technologies, animal models and human immunology.
ADITEC aims to:
- Develop advanced immunization technologies: adjuvants, vectors, formulations and delivery devices
- Select candidates, routes of immunization and prime-boost combinations in animal models
- Assess the impact of host factors in response to vaccination
- 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
- Develop concepts and tools to address regulatory and ethical issues posed by novel immunization technologies
- Create an internationally recognized training program for translational immunology and vaccinology.
In the first two years, 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 (immunogenicity and protection) has been completed. Recombinant vaccine vectors expressing ADITEC prototype antigens have been constructed and progress in the development of second generation adjuvants and vectors has been achieved. Besides that, different routes of immunization have been studied.
Challenge models have been established and comparative pre-clinical testing (immunogenicity and protection) of first generation adjuvants (CAF01, IC31, MF59, GLA-SE, Virosomes, Liposomes) was completed. There has been a call for the second comparative pre-clinical testing (immunogenicity and protection) of recombinant vectors and second generation adjuvants. Furthermore correlates of protection, immunogenicity at extreme of age, and T-cell of priming and prime-boost strategies have been studied.
Within the subproject ‘Human Immunology’great progress was achieved with seven clinical studies initiated, two studies in the protocol development phase and three in planning stages. Mmolecular signatures of immunity and immunogenicity were studied and systems biology analysis was made.
Regulatory and ethical issues
Other results besides the research part of the project, ADITEC addressed regulatory and ethical issues. The development of enabling regulatory frameworks has started, as well as the standardisation of novel technologies. WHO coordinated the completion of a white paper on Vaccine Research and Development: State of the Art of Generic Vaccine/Vaccination Technologies. The ADITEC ethics committee, including Dr. Cornelia Exner (animal studies) and Dr. Zarifah Reed (human studies) continue monitoring all relevant processes within the ADITEC project.
Training, dissemination, collaboration
ADITEC has the ambition to create an internationally recognized training program for translational immunology and vaccinology. For the Master Programme in Vaccinology and Pharmaceutical Clinical development, 6 fellowships were funded. ADITEC supported 15 fellowships for ADVAC courses (Advanced Course of Vaccinology). Besides this, a theoretical course (12 fellowships) and a practical course (6 fellowships) in ‘Adjuvants and Vaccine formulation’ were organized. Fellowships will be available for the next ADVAC course and a new edition of ‘Adjuvants and Vaccine Formulation’ training course will be organized in September 2014.
So far, the ADITEC project delivered approximately 40 scientific publications and results were presented at several international meetings. Dissemination of results was also made through the ADITEC website and several editions of the newsletter. Five affiliated partners have joined the project, and there are still more to come.
More information can be found in the presentation of Donata Medaglini.