HORIZON EUROPE
Europeo
Scope:Specific challenge
In view of the current epidemic, the WHO has identified the progression of vaccine candidates currently in development as an urgent public health need. Several candidate vaccines are available. Prime/boost vaccine approaches are promising, as they may provide protection against Ebola infection that is of longer duration.
Scope
Design and implementation of Phase I, II, or III clinical development of vaccine candidates, including prime boost combinations against Ebola virus disease (Zaire), to start in early 2015. The applicants must have vaccine candidates available and demonstrate the ability to roll out clinical trial vaccination programmes in EU / Africa, and to conduct studies in areas where Ebola virus disease is endemic. The clinical development programme(s) need(s) to be aligned with the global effort coordinated by the WHO.
Proposals addressing Topic 1 must include plans to set up a Central Information Repository for the Ebola+ programme for sharing results, learnings and data both amongst Ebola+ partners and with the outside community. The information repository should include (but not exclusi...
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Scope:Specific challenge
In view of the current epidemic, the WHO has identified the progression of vaccine candidates currently in development as an urgent public health need. Several candidate vaccines are available. Prime/boost vaccine approaches are promising, as they may provide protection against Ebola infection that is of longer duration.
Scope
Design and implementation of Phase I, II, or III clinical development of vaccine candidates, including prime boost combinations against Ebola virus disease (Zaire), to start in early 2015. The applicants must have vaccine candidates available and demonstrate the ability to roll out clinical trial vaccination programmes in EU / Africa, and to conduct studies in areas where Ebola virus disease is endemic. The clinical development programme(s) need(s) to be aligned with the global effort coordinated by the WHO.
Proposals addressing Topic 1 must include plans to set up a Central Information Repository for the Ebola+ programme for sharing results, learnings and data both amongst Ebola+ partners and with the outside community. The information repository should include (but not exclusively be restricted to): The capability to capture basic experimental data via an electronic lab notebook; A pharmacological screening platform for the capture, analysis and sharing of assay data and a system for capturing, analysing and sharing translational/clinical data. Applicants should in the first instance re-use capabilities that have been developed in other IMI projects and new capabilities should only be developed where no other alternative already exists. Finally any solution should include a strategy that ensures the long term sustainability of the data so that it remains accessible to the scientific community beyond the time-line of the project.
In addition, proposals addressing Topic 1 should include plans to set up a Scientific Advisory Board including proposed membership representing key stakeholders to give scientific and strategic advice to both specific projects and to the overall programme. Likewise, proposals should include plans to set up an Ethics Board whose role would be to ensure that all activities carried out under the programme fully account for any ethical considerations[1].
It is considered that an IMI2 JU financial contribution of 70-110 million and an EFPIA in-kind contribution of EUR 10-20 million would allow this specific challenge to be addressed appropriately. Nevertheless, this does not preclude submission and selection of proposals requesting other amounts.
Clinical study designs and therefore costs are likely to be influenced by several external factors such as; evolution of the current outbreak in West Africa and the precise requirements of regulatory authorities.
Expected impact
The vaccine development programme(s) are/is expected to provide the data to assess the safety, immunogenicity and efficacy of the candidate vaccine(s) in preventing EVD. The projects are thus expected to have a major impact on global health, both at the individual and the public health level. Learnings from this programme will also have an impact on the worldwide capacity to quickly develop vaccines in situations of global public health emergencies.
Special information
Since the implementation of Phase I, II, and III clinical trials is linked to manufacturing capability, projects funded under Topics 1 and 2 of this Call are expected to work in collaboration to ensure maximal impact.
[1] Ethics pre-screening and ethics review - IMI2 Manual For Submission, Evaluation And Grant Award
Cross-cutting Priorities:International cooperation
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Características del consorcio
:
La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Características del Proyecto
Los costes de personal subvencionables cubren las horas de trabajo efectivo de las personas directamente dedicadas a la ejecución de la acción. Los propietarios de pequeñas y medianas empresas que no perciban salario y otras personas físicas que no perciban salario podrán imputar los costes de personal sobre la base de una escala de costes unitarios
Los otros costes directos se dividen en los siguientes apartados: Viajes, amortizaciones, equipamiento y otros bienes y servicios. Se financia la amortización de equipos, permitiendo incluir la amortización de equipos adquiridos antes del proyecto si se registra durante su ejecución. En el apartado de otros bienes y servicios se incluyen los diferentes bienes y servicios comprados por los beneficiarios a proveedores externos para poder llevar a cabo sus tareas
La subcontratación en ayudas europeas no debe tratarse del core de actividades de I+D del proyecto. El contratista debe ser seleccionado por el beneficiario de acuerdo con el principio de mejor relación calidad-precio bajo las condiciones de transparencia e igualdad (en ningún caso consistirá en solicitar menos de 3 ofertas). En el caso de entidades públicas, para la subcontratación se deberán de seguir las leyes que rijan en el país al que pertenezca el contratante
Características de la financiación
Please note that submitting proposals for this call can only be done through the IMI SOFIA software tool.
Please read carefully all provisions below before the preparation of your application.
List of countries and applicable rules for funding: described in part A of the General Annexes of the General Work Programme.
Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation (EU) N° 622/2014 of 14 February 2014
Evaluation For a guide to the submission and evaluation process including evaluation criteria and procedure, scoring and threshold: please see the IMI2 Manual for submission, evaluation and grant award.
See also the proposal templates and evaluation form in section 6, below.
Proposal page limits and layout: Please refer to IMI2 RIA Proposal Template in section 6, below.
Indicative timetable for evaluation and grant agreement:
Information on the outcome of one-stage evaluation: maximum 2 months from the final date for submission.
Signature of grant agreements: maximum 1 month from the date of informing successful applicants.
Provisions, proposal templates and evaluation forms for the type(s) of action(s) under thi... Please read the IMI2 2nd Call Topic Text for full details of this topic.
Please note that submitting proposals for this call can only be done through the IMI SOFIA software tool.
Please read carefully all provisions below before the preparation of your application.
List of countries and applicable rules for funding: described in part A of the General Annexes of the General Work Programme.
Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation (EU) N° 622/2014 of 14 February 2014
Evaluation For a guide to the submission and evaluation process including evaluation criteria and procedure, scoring and threshold: please see the IMI2 Manual for submission, evaluation and grant award.
See also the proposal templates and evaluation form in section 6, below.
Proposal page limits and layout: Please refer to IMI2 RIA Proposal Template in section 6, below.
Indicative timetable for evaluation and grant agreement:
Information on the outcome of one-stage evaluation: maximum 2 months from the final date for submission.
Signature of grant agreements: maximum 1 month from the date of informing successful applicants.
Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:
Summary of the most relevant provisions for participating in IMI2 actions
IMI2 RIA Proposal Template
IMI2 RIA Evaluation Form
IMI2 Model Grant Agreement
Información adicional de la convocatoria
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