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Manufacturing and Development for Rapid Access Ebola Vaccine (EBOMAN) – Sofia ref.: 115850

Objective

This topic response (Topic 2: Manufacturing Capability) forms part of an integrated proposal to address the urgent unmet needs of accelerating the development of an Ebola vaccine. To help facilitate this main goal additional activities will be performed; the generation of sufficient vaccine and the capacity increase for generating more vaccine by means of process scale up and improvements.

The main objectives of this proposal are to manufacture sufficient supplies (and overages) for the clinical studies described in topic 1 and to prepare for a rapid access to large quantities of Ad26.ZEBOV (prime) and MVA-BN®-Filo (boost) vaccine in case of further escalation of the Ebola outbreak (The clinical development may change requiring an alternative vaccine combination; vaccination strategy. Any changes will be subsequently reflected in the manufacturing of clinical supplies). In conjunction with topic 3 (Transport and Rapid Access Ebola Vaccine) we should be able to respond quickly to future emergency needs of the vaccine.

The program therefore covers immediate manufacturing of clinical material and creation of additional capacity (by scale up, process improvements) and product understanding (BSL classification downgrading, process and product characterisation) to cope with increased need for the vaccine. The program includes:

Manufacturing, release and supply of Ad26.ZEBOV and MVA-BN®-Filo vaccine candidate for clinical studies (outcome: released clinical material)

Process Development activities required to ensure scale up of Ad26.ZEBOV manufacturing to 50L and fully define the 300L scale MVA BN®-Filo production.

Execute process development activities to ensure scale up of Ad26.ZEBOV and MVA-BN®-Filo to support potential manufacturing of up to 4M doses

Process Development and further scale up to support potential manufacturing of 10-20M doses

Generate material for further stability investigations towards late phase

Fields of science (EuroSciVoc)

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Keywords

Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)

Programme(s)

Multi-annual funding programmes that define the EU’s priorities for research and innovation.

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.

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

VIBALOGICS GMBH
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.

€ 1 023 325,00
Address
ZEPPELINSTRASSE 2
27472 Cuxhaven
Germany

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Niedersachsen Lüneburg Cuxhaven
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
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.

€ 1 023 325,00

Participants (2)

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