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Vaccine safety and immunogenicity signatures of human responses to VSV-ZEBOV – Sofia ref.: 115842

Objective

The proposal, VSV-EBOVAC, directly addresses the topic 1 of the IMI2 call on Ebola by supporting the clinical development of a highly promising new Ebola vaccine candidate, the vesicular stomatitis virus (VSV)‐ vectored Zaire Ebola vaccine (VSV-ZEBOV). In non-human primates, a single dose of VSV-ZEBOV elicited a strong (100%) and long-lasting protective efficacy against Ebola Zaire infections. Developed by Public Health Canada and manufactured by NewLink Genetics, VSV-ZEBOV was thus selected by the World Health Organization (WHO) as one of the 2 most promising vaccine candidates. To accelerate its clinical development, the WHO has organized a consortium and supported the organization of parallel first-in-man Phase I/II clinical trials, both in Europe and Africa. The primary objectives of these trials, initiated mid-November 2014, are to study the safety and antibody-inducing capacity of various doses of VSV-ZEBOV in European and African populations.

We propose to build upon this asset to acquire new and critical knowledge of the innate and adaptive immune responses elicited in humans by VSV-ZEBOV vaccination, with specific emphasis on trancriptomics and metabolomics signatures. To this aim, we have constructed a consortium including representatives from the vaccine manufacturer, scientists of the 3 main clinical sites (Switzerland, Gabon, Kenya) and world-leaders in immunology and partners of ADITEC, a large FP7- supported collaborative research programme aiming to accelerate the development of novel, powerful immunisation technologies for next-generation vaccines. We propose an ambitious program using cutting-edge technologies to perform an in depth characterization of the clinical samples harvested before/after VSV-ZEBOV immunization of 200 volunteers in Switzerland, Gabon and Kenya, and to extend the recently initiated clinical studies up to 12 months to identify the signatures and determinants of persistent immune responses.

Fields of science (EuroSciVoc)

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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.

IMI2-RIA - Research and Innovation action

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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) H2020-JTI-IMI2-2014-02-single-stage

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Coordinator

SCLAVO VACCINES ASSOCIATION
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.

€ 841 250,00
Address
PIAZZA LA LIZZA 7
53100 Siena
Italy

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Region
Centro (IT) Toscana Siena
Activity type
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.

€ 841 250,00

Participants (12)

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