Malaria vaccines

Published on 30 July 2008
Deadline: 30 November 2008

Malaria caused by P. falciparum kills about 1 million people annually, mostly children living in sub-Saharan Africa. Among the methods for controlling malaria, effective vaccines that provide strong and lasting immunity would be the most cost-effective interventions to introduce into public health services. The main objective of the call is to conduct Phase I/II trials of malaria vaccines in African countries, including age de-escalating clinical trials. These may include safety, immunogenicity and efficacy trials in target populations which might be infants or children depending on transmission intensity and prior exposure.

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Call for the support of clinical trials, capacity building and networking in malaria vaccines development

Grant scheme	Integrated Project (Clinical Trials/Capacity Building/Networking)
Disease	Malaria
Call identifier	IP_08_31100
Total available funds*	€6.5 million
Open for application	30 July 2008
Closed for application	20 November 2008

* We expect the EDCTP contribution of to be matched by at least an equivalent amount of cofunding from the EDCTP-EEIG Member States and possibly from other organisations (third parties).

Description of the Grant Scheme
The main objectives of EDCTP are to support the development of new clinical interventions to fight HIV/AIDS, malaria and tuberculosis, to promote European research integration and to foster strong partnership with and between scientists in African countries. In addition EDCTP aims to strengthen capacity for carrying out clinical trial activities in Africa. In order to realise these objectives EDCTP is supporting multi-centre projects which combine clinical trials with capacity building and networking. These components should be closely integrated in such a way as to ensure that the capacity development and networking established are utilised to successfully conduct the clinical trials under the best practices and to promote sustainability of clinical capacity in Africa. The scope of this call has been determined through consultation with experts in the field and based on products currently in the development pipeline. The projects should consist of four work packages that must include project management, clinical trial, capacity building and networking. The project will be managed by the project coordinator who will be responsible for the initiation, development and completion of overall activities within the project. Proposals in which the project coordinator is a national of a sub-Saharan African country based at an African institution are particularly encouraged.

Purpose of this grant
Malaria caused by P. falciparum kills about 1 million people annually, mostly children living in sub-Saharan Africa. Among the methods for controlling malaria, effective vaccines that provide strong and lasting immunity would be the most cost-effective interventions to introduce into public health services. The main objective of the call is to conduct Phase I/II trials of malaria vaccines in African countries, including age de-escalating clinical trials. These may include safety, immunogenicity and efficacy trials in target populations which might be infants or children depending on transmission intensity and prior exposure.

The clinical trial should aim to enhance the capacity to conduct clinical trials on malaria vaccines in sub-Saharan Africa by establishing new study cohorts through baseline epidemiological studies, training of African scientists, enhancing institutional capacity and providing relevant training for the staff employed at the African partner institutions in the project. The project should also incorporate networking activities which may include exchange visits (both north-south and south-south), mentorship schemes and training workshops. The project should be carried out by a consortium of competent investigators committed to the project, which must include participants from at least two European EDCTP-EEIG member states, an Africa institution with a good track record on malaria vaccine or related clinical research (established clinical trial site) and at least one additional centre in Africa, which could serve as clinical trial site for future large scale trials.

Please note that clinical trials activities in Europe are outside the scope of EDCTP.

General environment prerequisites:
National level

Evidence of country preparedness and support for the conduct of trials (such as a national malaria control programme; access to appropriate regulatory and ethical procedures for clinical trial application; and policy regarding access to malaria treatment and prevention)
A link to the EDCTP programme on National Regulatory Agency (NRA) capacity strengthening as well as on training of ethics committees is desirable

Community level

Evidence of community support for the conduct of trials, including experience with community advisory boards or other community and social behavioural studies

Research environment

Basic clinical, laboratory and data management infrastructure with a track record of accomplishments in clinical trials on infectious diseases and capable of conducting large-scale malaria vaccine trials in the future.
This call aims to fund 1 or 2 projects. There is no limit on additional funds obtained for a project from Member State cofunding or third party funding. It is anticipated that the EDCTP-EEIG member states will together aim to match the EDCTP funds committed to this call.

Eligibility criteria and administrative requirements

These include: application of proposal submission before the deadline in pdf-format, compliance with the rules stipulated in the Guidelines for applicants, correct length of the application form, application in English and the appropriate legal status of the applicant.
Environmental Screening Note (ESN) and recommendations for minimising any environmental impact have to be provided.

In addition, the following conditions also apply:

Participants in a proposal must be drawn from at least two publicly funded institutions from the EDCTP EEIG Member States; and at least two sub-Saharan African institutions.
While participation from the private sector is encouraged, the project coordinator must be employed by a not for profit institution and must be a resident of either an EDCTP-EEIG Member State or a sub-Saharan African country. Preference will be given to proposals where the project coordinator is a sub-Saharan African national based in Africa.
Projects should last no more than 5 years
EDCTP was established under Article 169 of the EU Treaty. This means that EDCTP Member States have agreed to provide funding from their national research programmes to EDCTP activities. Therefore all European partners in a proposal, including those working in sub-Saharan African institutes, must each apply for cofunding from at least one of the EDCTP-EEIG member states (normally but not necessarily their own). This has to be demonstrated by including with the proposal at least one supporting letter detailing all partners for that country per participating European MS from a legal entitled authority (e.g. University, Medical Centre or other research institution) or the EDCTP European Networking Officer (ENO) of the relevant EDCTP-EEIG member state confirming that an application for cofunding has been requested. If a cofunding letter is provided by someone other than the EDCTP European Networking Officer, then a copy of the cofunding letter should also be sent to the ENO concerned. Please note that although this eligibility requirement does not apply to African scientists, they are also encouraged to apply for cofunding from either EDCTP-EEIG member states, African countries or other bodies as additional funding for African researchers may be available. For more information about the possibilities of cofunding by EDCTP-EEIG member states, please contact the relevant national EDCTP European Networking Officer using the contact ENO form on the EDCTP website.
In order to be eligible for funding by EDCTP, each successful project must also secure EDCTP EEIG cofunding from at least two of EDCTP’s European Member States before a final selection is made.
The EDCTP EEIG Member States would normally be expected to at least match the funds for the project provided by EDCTP.
Cofunding contributions of the EDCTP-EEIG member states should adhere to local legal requirements.

Selection criteria
All proposals will be reviewed based on the following criteria:

Scientific criteria
I. Project excellence (objectives, feasibility, impact, innovation, quality and record of investigators, quality of the proposed methodology)
II. EDCTP relevance (public health relevance for developing countries, adequacy of proposal in context of the call, alignment with the prioirities of the EDCTP Joint Programme)
III. Potential impact (need for strengthening, restructuring existing research capacities, knowledge dissemination, sustainability)
IV. Compliance with national and international standards of research, Good Clinical Practice, ethics and safety related issues (in accordance with EDCTP guidelines)
V. Implementation plan of capacity building (research activities, staff and facilities development, networking activities, training activities, consortium management activities, work planning and package of each participant including deliverable list, performance indicators)
VI. Consortium description (role of participants, achievement of objectives, involvement of private sector, participation of at least two public institutions from European EEIG Member States as well as 2 African Institutions).
VII. Project Management (organisational structure, decision-making mechanisms, knowledge management)
VIII. Clinical trial management (product development committee, sponsorship, daily management for the trial)
IX. Project resources (cofunding arrangements, mobilisation of resources - personnel, equipment and finances in accordance with EDCTP financial requirements)
X. Gender issues (promotion of gender equality, gender action plan concerning the staff involved in the project).

Threshold
Selection criteria I-X will be assessed on a scale of five categories from "Poor" to "Excellent".
EDCTP 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:
II. EDCTP 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.
X. Gender issues: this selection criterion does not have a threshold.

List of the EDCTP-EEIG member states
Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.

List of sub-Saharan African countries
Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Democratic Republic of Congo, Republic of Congo, Ivory Coast, Equatorial Guinea, Eritrea, Ethiopia, Gabon, the Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia and Zimbabwe.

Selection procedure
Applications are to be submitted as full-proposals and will be peer-reviewed in a one-stage procedure. EDCTP has developed guidelines for applicants on the calls for support of integrated projects on clinical trials, capacity building and networking, which outline the procedures for preparation, submission and selection of applications for Clinical Trials/Capacity Building grants. EDCTP reserves the right to adapt the timelines of procedure in case of unexpected events. EDCTP will decide upon the applications on its sole discretion and in conformity with its governing structure.

Additional information

Each project may receive additional third-party funding
Large consortia with multiple partners are encouraged for all projects
Please note that EDCTP will be not be the legal sponsor of any trial
The Developing Countries Coordinating Committee (DCCC) consisting of prominent African scientists and health professionals is an independent advisory body for EDCTP. Please contact DCCC members, using the contact DCCC form on the EDCTP website, for information on collaborations in Africa.

Terms and condition for application
Applicants must comply with the instructions in the guidelines for applicants when completing the Application form. For this call the application for national cofunding will have to comply with the requirements of the funding agencies within each individual member state.

Please use the contact form to get more information from the European Networking Officer or our DCCC members.

Intellectual Property Rights
EDCTP will ensure that the Investigational Product or its successors shall be accessible and available at an affordable price in developing countries.

Legal information and support
EDCTP is supported by the Directorate General for Research of the European Commission, via Article 169 of the Treaty, decision No 1209/2003/EC of the European Parliament and of the Council of 16 June 2003.

EDCTP conforms to the legislation of The Netherlands concerning the Personal Data Protection Act.

Submission
Complete applications should be submitted electronically (via email) to: proposals[at]edctp.org

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For submission please use and read carefully the following documents:

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