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Late-stage clinical development of Chikungunya vaccines in endemic countries (CHIKV) and Controlled Human Infection Models for SARS-CoV2 and other beta coronaviruses (CHIM).

Project description

Clinical development of Chikungunya virus vaccines

Chikungunya virus (CHIKV) is a mosquito-borne pathogen that causes debilitating fever and joint pain. Currently there are no specific antiviral treatments available. While several CHIKV vaccines have reached pre-licensure stages, further studies are needed to assess their long-term safety and effectiveness. The EU-funded CHIKVAX_CHIM project proposes to support the clinical development of CHIKV vaccines into phase IV clinical trials, focusing on vulnerable populations such as children, immunosuppressed individuals and pregnant women. This initiative is part of a broader agreement between the coalition for epidemic preparedness innovations (CEPI) and the European Union to develop medical countermeasures for emerging epidemic threats. Moreover, the project will advance research on vaccine-induced mucosal immunity and establish a global expert network on controlled human infection studies.

Objective

A Framework Partnership Agreement (FPA) between the Coalition for Epidemic Preparedness Innovations (CEPI) and the European Union (EU) was signed in April 2019, to finance and coordinate the development of new medical countermeasures to prevent and contain infectious disease epidemics, which are of particular concern to low- and middle-income countries. As part of the FPA, a call for proposals (CfP) was launched jointly with the EU and supported the preclinical development of Rift Valley Fever Virus vaccines and the late-stage development of Chikungunya virus vaccines (CHIKV). While previous funding has led to the development of pre-licensure CHIK vaccines, in this current application we like to further advance our CHIK vaccine programme, and support CHIK vaccines that are near or have achieved regulatory licensure by supporting their clinical development into phase IV clinical trials to increase our understanding of the long-term safety, durability of protection, and effectiveness against virologically confirmed disease. Furthermore, we would like to expand the use indication by supporting clinical trials in vulnerable populations, including children, immunosuppressed and pregnant women. 

As part of this grant application, we also like to launch a CfP on Controlled Human Infection Models (CHIM). The overall objective of the CHIM proposal is to support research projects that increase knowledge in vaccine-induced mucosal immunity and advance the development of transmission-blocking vaccines against coronaviruses and other potential respiratory viral threats. The expected outcome of this CfP is to create a global network of experts conducting CHIM at a high level of consistency and reliability.

This current grant application seeks to leverage €70M from Horizon Europe, which will be supplemented with €30M from CEPI making a pool of €100M. Awards will have a 36–48-month duration and will be administered by the CEPI secretariat.

Fields of science (EuroSciVoc)

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Keywords

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Programme(s)

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Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

HORIZON-COFUND - HORIZON Programme Cofund Actions

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) HORIZON-HLTH-2022-CEPI-15-IBA

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Coordinator

COALITION FOR EPIDEMIC PREPAREDNESS INNOVATIONS
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 70 000 000,00
Address
SKOYEN ATRIUM ASKEKROKEN 11
0277 Oslo
Norway

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Research Organisations
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 100 000 000,00
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