Summary, EVI Rendez-Vous 2013
On 4 December 2013 the annual review of EVI took place, once again in Heidelberg, Germany. More than 80 stakeholders, comprising Governing bodies, funders, research partners from the various EVI funded projects, and EVI Secretariat, gathered to present and discuss project progress and research findings.
The topics covered an overview of the EVI portfolio, specific preclinical-, clinical- and harmonisation activities. This year was marked by the diversification of EVI’s portfolio with two new targets, paratyphoid vaccine (PIM) and universal influenza vaccine (EDUFLUVAC), as well as a new technology IMX313, an immune-enhancing antigen which is being assessed for a Staphylococcus Aureus vaccine (BELLEROPHON).
Specific attention was given to progress on Pregnancy Associated Malaria (PAM) vaccine candidates, summarising the various approaches to develop the var2CSA antigen. Var2CSA is expressed by malaria parasites and leads to the adherence of parasitised erythrocytes to the walls of blood vessels in the placenta of pregnant women. Test results from multigravidae women show acquired partial immunity against PAM via antibodies against multiple domains of the malarial var2CSA antigen. After explaining how the most promising domains for vaccine development of the var2CSA antigen can be selected, the vaccine development pathway from domain selection towards the conduct of a clinical trial planned for 2015 was presented by the two leading groups working on PAM vaccine. PAM vaccine development is heavily funded by the Federal Ministry of Education and Research (BMBF) through KfW.
Several presentations were given on the Malaria Vectored Vaccines Consortium (MVVC coordinated by EVI), which is testing a liver stage malaria vaccine candidate in a viral vectored prime-boost strategy. Promising results of recent phase IIb clinical trials in Kenya and Senegal were shown to the audience, and an overview was given of capacity building efforts in Senegal and Burkina Faso during the conduct of the project and the implementation of a phase IIb efficacy trial in Burkina Faso.
During a session dedicated to malaria blood stage vaccine candidates, the approaches to develop the RH5 antigen by various groups, Malaria Vaccine Initiative (MVI), NIH-NIAID and EVI were discussed, and ways forward to harmonise the decision process and to generate comparative results were raised. The RH5 antigen is also part of a multi-antigens, multi-stage approach assessed under the MultiMalVax project.
In addition, attention was given to the launches of two phase Ia/Ib clinical trials with two blood stage vaccine candidates (AMA1-DiCo and P27A), which are major milestones in the vaccine’s development, introducing the fast tract clinical development strategy implemented by EVI together with the Sponsors and principal investigators of the clinical trials. The fast tract clinical development strategy will allow earlier testing of the vaccine candidates in the targeted population. Two European and two African regulatory agencies have approved this innovative approach developed by EVI in collaboration with the African investigators.
For international comparison of clinical test results it is crucial to produce quality data (endpoints), such as the number of parasites monitored in the patient during a Controlled Human Malaria Infection (CHMI). A good example is the qPCR assay in the MolMalQ project on harmonisation of molecular malaria diagnosis. EVI is leading this global effort.
The success of the EC funded TRANSVAC project was presented, showing how the 29 various free services were effectively used by a variety of vaccine researchers or institutes to accelerate the development of vaccine. Another result of the TRANSVAC project was the Vaccine R&D Infrastructure Roadmap developed by the European vaccine community. This effort will hopefully pave the way for a sustainable European Vaccine Research Infrastructure.
In her closing words, Odile Leroy, Executive Director of EVI, thanked all speakers and other participants for their contributions. All the achievements of EVI would not be possible without the support of its funders, and the commitment of the Board, Board of Stakeholders and independent Scientific Advisory Committee members. Odile Leroy also underlined that the work of EVI is realised with a very efficient Secretariat with only 14 members, reducing overhead costs to a mere 3% of all expenditures and ensuring 97% of funds are spent on project activities.
More information on each project can be found under http://www.euvaccine.eu/portfolio/project-index.