Summary:

The goal of this 5-year project is to systematically develop and test malaria vaccines by comparative and continuous evaluation of candidates. Exploiting the capabilities of 2 SMEs, 8 European malaria vaccine research centres, the European Malaria Vaccine Initiative (EMVI) and the African Malaria Network (AMANET), the best malaria vaccine candidates will be selected and developed further within a process that includes antigen validation as well as the creation of a vaccine development rationale and early proof-of-principle clinical trials.

The internal Training Programme, which will be integrated with that of the existing Framework Programme 6funded malaria-oriented Network of Excellence (BIOMALPAR), will promote interdisciplinary collaboration through a joint PhD programme. EMVDA's research capacity building efforts will be channelled through our African partners, AMANET, in particular to support their subgroup of an "Afro Immuno-Assay Network". With emphasis on 'downstream' vaccine development and clinical trials, a product development management structure is be set up that is responsible for the technical and regulatory management of the transition of candidate vaccines between the production groups and the clinical testing groups. Working closely with the African Immuno-assay Network, standard operating procedures governing all in vitro and in vivo immunoassays used by the consortium during vaccine development will be developed and distributed.

In summary, the EMVDA brings together Europe's leading malaria vaccine researchers and pan-Union initiatives in an unprecedented collaboration with vaccine SMEs to drive the production and clinical development of an effective vaccine to protect those vulnerable to this disease and thus aid human development.

Background:

There is considerable optimism that a malaria vaccine can be developed. This is based on the fact that acquisition of immunity induced by natural infection does eventually prevent mortality and provide protection against clinical disease. There has been interest in the development of malaria vaccines for over thirty years with the initial research emphasis on attenuated or killed whole organisms and more recently on subunit-based approaches. The malaria parasite is a complex organism with an elaborate lifecycle; as a consequence much effort has been devoted to identifying molecules that stimulate host immunity and identifying protective components of that immune response. In parallel, research on delivery technologies has sought to develop ways to evoke protective immune responses by active immunisation.

There are three stages of the malaria parasite life cycle targeted for vaccine development: the preerythrocytic and the asexual and sexual blood stages. This project is very largely focused on the asexual blood stage that is responsible for the disease. This is the area in which European laboratories are probably most globally competitive and it allows us to focus our relatively limited resources to greatest advantage. The project's strategy includes the development of new 'engineered and improved' synthetic antigens, for example with amino acid sequences from two or more antigens or with modifications to improve immunogenicity.

Aim:

The overall objective of the project is to develop a vaccine for malaria. To do this a scientific and technological structure supported by effective management is established to move candidate malaria parasite antigens through five stages of preclinical and clinical testing. Individual candidates are at different stages of development. Stringent go/no-go criteria will be used to assess and compare competing antigens and delivery systems to focus resources on to the most credible vaccine candidates. Emphasis and resources will be focused on moving candidate vaccines into clinical trials.

Expected results:

The EMVDA is a European initiative that seeks to deliver progress in one area of the Commission's policy initiative - that of developing a malaria vaccine to reduce the burden of malaria. EMVDA provides the resources of its membership of leading European research laboratories to bring innovative elements into the structure and exploit new facilities to develop and test candidate vaccines and it joins this effort to the African effort to obtain and deploy a malaria vaccine. As an integral part of the malaria vaccine research & development process, the EMVDA will offer research partnership and preand post-doctoral training to African scientists.

Although Europe has a strong tradition and current strength in malaria research, it has not developed sufficient organisation to integrate applied research and industrial infrastructure. It is thus failing to exploit its fundamental scientific research. EMVDA, co-ordinated by EMVI, strengthens the European Research Area in this strategically important sector of biotechnology and promotes the European agenda laid out in the Barcelona Objectives in a number of areas including increasing skills and mobility.

Potential applications:

Malaria is one of the world's greatest public health problems. The development a malaria vaccine, which can prevent or reduce clinical malaria thereby effectively reducing malaria morbidity and mortality, will therefore have a major impact on human health. The endpoint of our efforts will be to immunize infants and children by integrating a malaria vaccine in the EPI program in malaria endemic countries.

Coordinator:

Partners:

Nº	Principal Scientific Participants	Official Address	Other Information
2	Reinhard Glück	CSO Etna Biotech Rehhagstrasse 79 CH-3018 BERN Switzerland	Tel: (41 31) 980 6518 Fax: (41 31) 980 6785 Email: Reinhard.Gluck@bernabiotech.com
3	Rinaldo Zurbriggen	Chief Scientific Officer Pevion Biotech Rehhagstrasse 79 CH-3018 Bern Switzerland	Tel: (41 31) 9806417 Fax: (41 31) 9806618 Email: rinaldo.zurbriggen@pevion.com
4	Adrian Hill	The Wellcome Trust Centre for Human Genetics Roosevelt Drive OXFORD OX3 7BN UK	Tel: (44) 1865 287759 Fax: (44) 1865 287686 Email: adrian.hill@well.ox.ac.uk
5	Alan Thomas	Biomedical Primate Research Centre P.O. Box 3306 2280 GJ RIJSWIJK The Netherlands	Tel: (31 15) 2842538 Fax: (31 15) 2843986 Email: thomas@bprc.nl
6	David Cavanagh	Institute of Immunology and Infection Research University of Edinburgh Kings Buildings EDINBURGH EH9 3JT UK	Tel: (44 131) 650 5459 Fax: (44 131) 650 7322 Email: david.cavanagh@ed.ac.uk
7	Michael Theisen	Department of Infectious Disease Immunology Statens Serum Institut 5, Artillerivej DK-2300 COPENHAGEN S Denmark	Tel: (45 32) 68 37 34 Fax: (45 32) 68 30 35 Email: MTH@ssi.dk
8	Robert Sauerwein	University Hospital Faculty of Medical Sciences PO Box 9101 6500 HB NIJMEGEN The Netherlands	Tel: (31 24) 3610577 Fax: (31 24) 3614666 Email: r.sauerwein@nmb.azn.nl
9	Anthony Holder	Division of Parasitology NIMR Mill Hill LONDON NW7 1AA UK	Tel: (44 208) 9593666 ext.2175 Fax: (44 208) 9138593 Email: aholder@nimr.mrc.ac.uk
10	Roma Chilengi	African Malaria Network Trust (AMANET) BOX 33207 DAR ES SALAAM Tanzania	Tel: (255) 22 2700017 Fax: (255) 22 2700380. Email: chilengi@amanet-trust.org
11	Gerd Pluschke	Swiss Tropical Institute Socinstr. 57 CH 4002 BASEL Switzerland	Tel: (41 61) 2848235 Fax: (41 61) 2848101 Email: Gerd.Pluschke@unibas.ch
12	Klavs Berzins	Department of Immunology, The Wenner-Gren Institute Stockholm University SE-10691 STOCKHOLM Sweden	Tel: (46-8) 164170, Fax: (46-8) 157356 Email: klavs@imun.su.se
13	François Spertini	Service d'Immunologie et d'Allergie Centre Hospitalier Universitaire Vaudois (CHUV-BH19) Rue du Bugnon 1011 LAUSANNE Switzerland	Tel: (41 21) 314 0790 / direct ... 0799 Fax: (41 21) 314 0791 Email: Francois.Spertini@chuv.ch