INYVAX
- Framework programme:
- 7
- Contract/Grant agreement number:
- 223532
- EC contribution:
- 932,335 €
- Duration:
- 36 months
- Funding scheme:
- Coordination Action
- Starting date:
- 01/02/2009
- Web-site:
- http://www.inyvax.eu
Keywords: malaria, vaccine, EMVI, EVI
Background
A number of new vaccines are being developed against poverty-related infectious diseases of major public health importance at global level. The development of these vaccines is facing the same kind of challenges and gaps, which still prevent the following: a) establishment of readily accessible formulation and scale-up process development capacity for neglected disease vaccines; b) establishment of a systematic approach for prioritising formulation of vaccine candidates using accepted preclinical criteria; c) development of information-sharing tools to strengthen connections between scientists, developers and clinical investigators.
The European vaccine community needs to establish both a shared vision and goals to identify the activities required to address these challenges. Cooperation between the different groups of PRD vaccine developers will bring innovative approaches for accelerating the development of effective vaccines. Several of these challenges, set out below, can be addressed through coordination:
- difficulties in accessing some technology platforms, such as synthetic peptides/recombinant proteins and expertise for good manufacturing practice (GMP)development, therefore allowing rational decisions to be made based on the best industrial approach for pharmaceutical development;
- difficulties in accessing certain types of knowledge and know-how, such as lyophilisation and lack of formulation platforms accessible to academic groups;
- difficulties in accessing some delivery platforms, such as adjuvants and virus-like particles for GMP development and/or to assess the quality and regulatory compliance of those platforms;
- difficulties in harmonising the safety data collection;
- insufficient numbers of trained scientists able to undertake leadership roles in vaccine development.
Aims and potential applications
INYVAX aims to address these challenges by:
- Establishing a comprehensive database of marketed vaccine technologies, addressing the advantages, constraints and limits of each technologies and additional criteria such as transferability of the know-how, benchmarking, production costs or regulatory compliance.
- Optimizing knowledge and resources for the Formulation of PRD vaccines by establishing the European branch of the adjuvants network AdjuNet and a training programme in adjuvant safety.
- Implementing safety standards in clinical trials of PRD vaccines, allowing meta-analysis of the safety of similar vaccine approaches.
- Funding a training programme in vaccinology, including the topics: Pre-clinical vaccine research, Design and monitoring of clinical trials, Vaccine safety issues, Selection of new and appropriate vaccination strategies and Effective communication.
The main impacts of this coordination action are:
- Implementation of knowledge and technology resources for PRD vaccine developers and development of a common strategy across PRD vaccines
For both formulation work and adjuvant assessment this coordination action will develop tools and mechanisms to improve the sharing and the access to knowledge, know-how and information across PRD vaccine developers, in a very specific technical niche, which is largely “orphan” in both academic and biotech settings.
- Improvement of the assessment of PRD vaccines
This action will increased awareness of Brighton standards among the WG participants and stakeholders in international vaccine development and improved applicability and “user-friendliness” of Brighton case definitions, data collection guidelines, and online tools.
The improvement of collaboration with partner networks and organisations involved in international vaccine safety will create a momentum for improvement of clinical trials and therefore the comparability and the assessment of the safety results during the course of clinical development, allowing meta-analysis of safety across clinical trials for a same type of vaccine formulation and/or different vaccines using same technologies or adjuvants.
This will also enable the generation of hypotheses and funding for implementation projects in developing countries.
- Contribution to create a pool of trained and competent vaccine developers
A high level of interactions will occur during courses between people from different horizons, e.g. academia and industry. Contacts established during the courses are valuable for building of international vaccinology networks. At the present stage, there is no European forum that would help to gather immunologists, epidemiologists, pediatricians, public health experts or biotechnologists interested in this area. The proposed training programme will provide such opportunities. It will also offer the possibility for European scientists to establish contacts with other scientists from developing countries and will favour North-South collaborations. Dissemination of information will be optimally done through the establishment of these networks.
Coordinator:
Dr Odile Leroy
European Vaccine Initiative
Heidelberg
Germany
odile.leroy@euvaccine.eu
Partners:
| Nº | Principal Scientific Participants |
Official Address | Other Information |
| 1 | Dr Christophe Longuet | Foundation Merieux Lyon France |
Email: christophe.longuet@fondation-merieux.org |
| 2 | Prof. Paul-Henri Lambert | University of Geneva Geneva Switzerland |
Email: paul.lambert@unige.ch |
| 3 | Dr Ed Remarque | Biomedical Primate Research Centre Rijswijk Netherlands |
Email: Remarque@bprc.nl |
| 4 | Dr Jelle Thole | TuBerculosis Vaccine Initiative Lelystad Netherlands |
Email: jelle.thole@tbvi.eu |
| 5 | Dr Christian Loucq | PATH Malaria Vaccine Initiative Seattle USA |
Email: cloucq@malariavaccine.org |
| 6 | Dr Ulrich Heininger | Brighton Collaboration Basel Switzerland |
Email: ulrich.heininger@ukbb.ch |
| 7 | Dr Martin Friede | WHO Global Adjuvant Development Initiative Geneva Switzerland |
Email: friedem@who.int |
