To contribute to the European Commission's Accelerated Action for Control of the Poverty Related Diseases by sustaining and expanding a European Clinical Trials and Development Platform for Malaria vaccines, enabling co-ordination of EC and EU efforts. To ensure international co-ordination and collaboration in malaria vaccines development and testing. To put in place a structure needed to ensure rapid and flexible reaction to technological and scientific breakthroughs in malaria vaccine development. To provide a mechanism for EU Member States' financial contributions towards achieving the common goal of developing affordable and accessible vaccines in endemic areas.
The objectives of this project are:
1) to contribute to the European Commission's Accelerated Action for Control
of the Poverty Related Diseases by sustaining and expanding a European clinical
trials and development platform for malaria vaccines, enabling coordination of
EC and EU efforts
2) to ensure international coordination and collaboration in malaria vaccine development and testing
3) to put in place a structure that is needed to ensure rapid and flexible reaction to technological and scientific breakthroughs in malaria vaccine development
4) to provide a mechanism for EU Member States' financial contributions towards achieving the common goal of developing affordable and accessible vaccines in endemic areas.
The EMVI secretariat proposes to manage the development of candidate malaria vaccines within the EU by creating a pipeline from GMP manufacture to clinical trials in the EU, and to clinical trials in Africa together with AMVTN. The main aims are:
1) the evaluation of proposals, by the EMVI scientific advisory committee
(SAC), from EU research institutions for the GMP manufacture of clinical grade
candidate malaria vaccines
2) the creation and management of product development teams to oversee GMP manufacture
3) the creation and management of clinical trials and development teams to oversee the phase I, and possibly phase II, clinical trials in Europe. This also involves the development of clinical protocols
4) the management of the SAC for GMP/clinical trial applications and evaluations to decide whether vaccine candidates should be advanced to clinical trials in Africa with AMVTN
5) together with AMVTN, and/or other international bodies, the management of clinical trials in one or more sites within Africa
6) the data management of the GMP manufacture and clinical trials
7) the negotiation and management of the financial contracts supporting these activities
8) the development of contracts with EU Member State's research councils for financial support to fund these activities
9) the development of vaccine initiatives with other EU and international agencies to support a global approach to malaria vaccines, as supported, for example, by the Memoranda of Understanding
10) the preparation of reports on all these activities to the EMVI Board, and attendance at the EMVI Board Meetings.
EMVI will appoint the manager, deputy manager and finance/office manager upon initiation of the award. During the contract, the secretariat will manage the GMP manufacture of up to ten candidate vaccines, and advance these through clinical trials in Europe. It will manage collaboration with AMVTN on clinical site strengthening, and the clinical trials of six candidate malaria vaccines, with the expectation that one candidate vaccine will enter expanded efficacy trials by the end of the contract.
Statens Serum Institut,
Office of International Health
Statens Serum Institut Artillerivej 5
2300 Copenhagen S, Denmark
Tel: +45 32 683188
Fax: +45 31 683228