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ADITEC Report Summary

Project ID: 280873
Funded under: FP7-HEALTH
Country: Italy

Periodic Report Summary 5 - ADITEC (Advanced Immunization Technologies)

Project Context and Objectives:
Recent advances in science and technology are transforming the old field of vaccinology into one of the most dynamic of this century and have opened the door to fighting those diseases that have been reluctant to vaccine development, transforming medicine of the future.
The scope of this project is to produce the knowledge necessary to develop novel and powerful immunization technologies for the next generation of human vaccines. This goal requires a multidisciplinary approach in which diverse but complementary scientific disciplines and technologies converge. Therefore some of the most competitive European research groups from public institutions and biotechs have agreed to join forces in ADITEC, together with top US groups on systems biology and adjuvants, to support this enterprise and accelerate development of the novel concept of vaccines and vaccination. The strong translational focus of the undertaking is reflected by the large group (14) of participating SMEs as well as by the strong and dedicated involvement of 3 major large pharma companies active in the field of vaccine R&D.
To reach the above mentioned aim the project is structured around two major components: 1) human immune response to vaccination studied through latest generation methodologies and 2) development of advanced immunization technologies. These two components are strictly interlinked and each benefits of the activities of the other as shown in the schematic representation of the ADITEC project structure.
A systems biology approach is used to study existing and experimental vaccines in patient characterization studies and in clinical trials, to investigate the effect of adjuvants, vectors, formulations, delivery devices, routes of immunization, homologous and heterologous prime–boost schedules, as well as the impact of host factors such as age, gender, genetics and pathologies. Animal models are used to complement human studies, and to select novel immunization technologies to be advanced to the clinic. A broad panel of adjuvants, live vaccine vectors, formulations and delivery devices are tested, compared, selected and optimised using common prototype antigens (influenza H1, M. tuberculosis H56 and Chlamydia MOMP).
From the preclinical studies, new concepts and tools have been generated. New vaccine candidates have been advanced a in phase I clinical trial. These trials will focus on a cutting-edge application of novel technologies developed that are a genuine advance or paradigm-change. Training curricula have been created to impact the formation of the next generation of researchers in the field.
The Scientific and Technological Objectives of the project can be summarised in:
1. Development of advanced immunization technologies: adjuvants, vectors, formulations and delivery devices
2. Selection of candidates, routes of immunization and prime-boost combinations in animal models
3. Assessment of the impact of host factors in response to vaccination
4. Development of concepts and tools from human immunization:
5. Development of concepts and tools to address regulatory and ethical issues posed by novel immunization technologies
6. Creation of an internationally recognized training program for translational immunology and vaccinology.

To address these issues in a coordinated manner, ADITEC is organised using a matrix structure where research themes and experimental approach are integrated.
Through this unprecedented effort, ADITEC promotes cross fertilization between different research areas and has the potential to fill the existing knowledge gaps and enable the introduction of new effective and safe immunization technologies. ADITEC is expected to constitute an cornerstone of a vaccine research partnership, contributing the structuring of the European Research Area (ERA) in the field of immunology and vaccinology.

Project Results:
ADITEC is making significant advances in the development novel immunisation technologies, adjuvants, vectors and delivery systems, formulations and vaccination methods optimised for different age groups. The project has developed a toolbox of novel immunization technologies with well profiled mechanisms of action. These have been tested head to head in animal models, combined in prime-boost strategies, and their mechanism of action has been investigated both in pre-clinical and clinical studies. Over the last five years, the project has delivered 12 clinical studies and is contributing to international regulation and standards for these novel Technologies. Along with regularly setting up and running European training programmes ADITEC has also created synergies and cross-fertilization between research areas that have the potential to fill existing gaps and advance this knowledge well into the future. ADITEC has provided support to SMEs and public health organisations for innovative research projects that were selected through 5 open calls. To protect discoveries for future research, consortium members have taken out four patents, with more in the pipeline. To date, ADITEC has a track record of 206 scientific publications in international peer-reviewed journals (see publication list). New technologies, along with efficient management and governance, can effectively advance these innovations to the clinic and make a real difference for future health.

Potential Impact:
The ADITEC project responds fully to the urgent need to develop advanced immunization technologies for safer and better vaccines. Technological advances from the ADITEC project will generate new knowledge on the human immune response regarding a range of innovative vaccine technologies that will impact prevention, alleviation or cure of disease.
ADITEC will impact on technology innovation through development of novel adjuvants, live vaccine vectors, formulations and delivery devices. The characterization of the mode of action, the comparative evaluation of efficacy profiles of these vaccine technologies will allow informed decisions on their use.
The evaluation of different immunization routes will provide information on the quality of immune response at different anatomical sites. Different prime-boost schemes will be comparatively evaluated and will provide information on the optimal combination of heterologous prime- boost strategies. By evaluating the efficacy of vaccine strategies, ADITEC will provide pre-clinical proof of concept for selected new immunization technologies allowing an informed decision on their use for new preventive or therapeutic vaccines.
ADITEC will assess the impact of host factors on successful immunization through coordinated preclinical, clinical and population-based studies to identify optimal immunization strategies for specific target groups. These studies will allow informed decisions for further clinical studies in different age groups.
Clinical activities will explore human applications of novel technology and basic immunology of improved immunization techniques, to elucidate fundamental mechanisms and identify generic techniques suitable for wider application to immunization. A significant number of human clinical studies will be undertaken, to gain insight into important aspects of vaccine development and vaccination. Systems biology will be applied to identify the molecular signatures that correlate with and predict adaptive and innate responses to vaccination. This information will allow a comprehensive compilation of immune responses to vaccination and be of high value for developing advanced vaccination strategies.
A clinical database will be established including extensive phenotypic and clinical information and will be used to study the immune response to influenza vaccination at a population level and understand the effect of genetic background, gender and disease on vaccine response. A panel of biomarkers and SOPs will be generated and used for the evaluation of new immunization technologies. The SOPs developed can easily be transferred to the EU R&D community and be translated for use with novel vaccine candidates. ADITEC will facilitate the establishment of a generic framework for national and international regulatory and standardisation guidelines for novel immunisation strategies. These activities will impact on the timely assessment of regulatory or standardisation challenges and on the ability to bring these into practice in humans. A fundamental aspect of the ADITEC project is the participation of large, small and medium enterprises. This project is a potential model for future public private partnerships and will result in enhanced and integrated exploitation by European industries contributing to increased competitiveness.
In addition, ADITEC training programs in vaccinology at Masters and at professional level, will impact on the formation of the next generation of EU researchers in the field.
ADITEC offers the unique opportunity for the cross-fertilisation of different scientific fields as well as the collaboration of scientists from different areas and institutions, to contribute to a true European research structure that will have a significant impact on the development of advanced immunization technologies into the future. ADITEC is therefore expected to build the foundation for a long-term European initiative and ignite the next generation of vaccine development.

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