Call for Selecting New Potential Malaria Vaccine Candidates and
the Developing Institutions to Enter into EMVDA
Grant scheme: Antigen Portfolio
Disease: Malaria
Call identifier: LSHP-CT-2006-037506
Open for application: 31 March 2008
Deadline for application: 5 May 2008
Description of the Grant Scheme
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.
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. In an effort to strengthen the EMVDA candidate vaccine portfolio we hereby announce a call for selection of new potential malaria vaccine candidates targeting the Plasmodium falciparum a-sexual blood stage to enter into EMVDA.
Purpose of EMVDA Grant
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.
Purpose of this Call
The purpose of the present call is to invite the scientific community to submit a proposal on the clinical testing of a malaria blood stage candidate vaccine. The institution developing the selected candidate will enter into the EMVDA consortium after positive selection through this call procedure and subject to a positive recommendation by the EMVDA ESAC, on the basis of EMVDA-derived preclinical assay results, that the product merits to proceed to GMP production and phase 1 trials. Institutions thereby entering the EMVDA consortium will therefore have to follow the rules and procedures already in place.
Eligibility Criteria
These include: proposal submitted before the deadline in pdf-format, completeness, compliance with the rules stipulated in Appendix I, correct length of the application form, application in the correct language (English). Applicant institutions must originate from one of the EU Member States or FP7 Associated Countries
The candidate vaccine proposal under this call will compete for GMP development resources with candidate products emerging from other EMVDA activities. Recommendation of candidate for selection for GMP development will be made though an External Scientific Advisory Committee (ESAC) that operates independently of EMVDA (as described in the accompanying technical annex). EMVDA has adopted a principle of using comparative assays to provide information to assist in down-selection; this principle has been endorsed by ESAC. The following technical and scientific conditions apply:
- The candidate vaccine will be compared insofar as possible with competing products through a pre-clinical comparative evaluation. To gauge comparative immunogenicity, and to measure functional effects of induced antibodies, applicants are invited to supply EMVDA with material for evaluation within the EMVDA assay work package. An appropriate design for the comparative study, including the immunisation phase of the study, should be agreed between applicants and the coordinator of the EMVDA assay work package before the study commences. EMVDA operates a policy of product-testing using blinded protocols and procedures. These studies are performed at the applicants own expense.
- This call aims to select one or more projects to enter into EMVDA.
Selection Criteria
All proposals will be reviewed based on the following criteria:
I. Project excellence i.e. objectives, feasibility, impact, innovation, quality and record of investigators, quality of the proposed methodology.
II. EMVDA relevance (public health relevance for developing countries, adequacy of proposal in context of the call, alignment with the prioirities of the 6 Framework Programme).
III. Potential impact (need for knowledge dissemination, sustainability).
IV. Compliance with national and international standards of research, Good Laboratory Practice.
V. Project Management (organisational structure, decision-making mechanisms, knowledge management).
VI. Project resources (including co-funding arrangements, mobilisation of resources - personnel, equipment and finances in accordance with EMVDA financial requirements)
VII. Gender issues (promotion of gender equality, gender action plan concerning the staff involved in the project).
Cofunding
Each successful proposal will be required to fund the comparative pre-clinical evaluation.
Threshold
All selection criteria will be assessed on a scale of five categories from "Poor" to "Excellent". The selection criteria I (see above) has the highest priority when ranking.
EMVDA has defined an overall threshold for all selection criteria of "Good" (third in the assessment scale) to ensure that all applications meet a minimum level of quality.
Exceptions are made for the following selection criteria:
I. EMVDA Relevance: the minimum level will be ‘Very Good’ (second in the assessment scale). If an application does not meet the minimum level, it will be automatically rejected.
II. Gender issues: this selection criterion does not have a threshold.
Eligible Member States
Same eligibility criteria as for the European Commission FP7
(see http://cordis.europa.eu/fp7/participate_en.html).
Selection Procedure
Applications are to be submitted as full-proposals and will be reviewed in a one-stage procedure by the EMVDA External Scientific Advisory Committee. EMVDA reserves the right to adapt the timelines of procedure in the event of unexpected events. Selection of the successful proposal will be made at the sole discretion of EMVDA and in conformity with its governing structure.
Additional Information
Please note that contributions from other organisations count as third party funding
Terms and conditions for application
Applicants must comply with the instructions in the Application Form.
Intellectual Property Rights
EMVDA consortium agreement has defined the rules for handling IPR (see Appendix I).
Legal Information and Support
EMVDA is supported by the European Commission.
Submission
Complete applications should be submitted electronically in PDF via email to Project Manager Regitze Louise Thøgersen (rlt@ssi.dk) and Coordinator Odile Leroy (oly@ssi.dk).
For submission please use and read carefully the following documents:
Application Form
Appendix I
Clinical Development Plan
Malaria Vaccine Technology Roadmap