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ETVAX – the first oral vaccine for protection against traveller’s diarrhoea caused by ETEC

Project description

The first oral vaccine against enterotoxigenic E.coli

Enterotoxigenic Escherichia coli bacteria (ETEC) are the cause of travellers’ diarrhoea (TD), which particularly affects people in developing countries. ETEC is transmitted via contaminated food or water and currently, there is no approved vaccine for its prevention. Biopharma in Sweden is developing an oral vaccine against TD associated with ETEC. The company is collaborating with the world’s prominent experts in ETEC vaccine research. The EU-funded ETVAX project will conduct a phase II vaccine study to allow Biopharma to take the necessary steps towards commercialisation. The successful introduction of the vaccine will reduce the number of TD cases among affected travellers and patients with irritable bowel syndrome or other chronic diseases associated with TD.

Objective

This project will perform a Phase II study of ETVAX – an oral vaccine against traveller’s diarrhoea (TD) caused by enterotoxigenic E. coli bacteria (ETEC). ETVAX has a strong potential to be the first vaccine with a full ETEC indication. TD caused by enterotoxigenic E. coli bacteria is the most common illness that affects travellers traveling in the developing
regions. Currently, there is no approved method for preventing TD.

Travellers are recommended to use off-label antibiotics such as Rifaximin or the cholera vaccine Dukoral to prevent TD. In business terms, there exists a strong business opportunity in developing and commercializing an effective and safe ETEC vaccine. Scandinavian Biopharma is the first SME positioned to capture this opportunity. The envisaged Phase II study will
allow Scandinavian Biopharma take the key step towards the commercialization of ETVAX.

The targeted users of are travellers visiting tropical and subtropical countries. Their number is forecasted to reach 190 million by 2020. Their key need is to prevent TD which can ruin a significant part of a vacation or a business trip. ETVAX will meet this needs by being safe, efficient and easy to use.

The project delivers an ultimate EU added value by offering the first ETEC vaccine with proven immunogenicity, safety and efficacy. From the scientific perspective, this means that the project fills the gap in the vaccine research on the EU and global level as no other efficient methods for prevention of TD have been proposed on the market to date. The introduction of ETVAX will ultimately decrease number of TD cases among travellers, decrease number of patients with irritable bowel syndrome or other chronic diseases connected to TD, as well as decrease healthcare costs and productivity losses on the EU level.

If successfully validated and accepted by regulatory bodies, ETVAX will take Scandinavian Biopharma to a new level of
competitiveness and growth.

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)

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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.

SME-2 - SME instrument phase 2

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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-SMEInst-2016-2017

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Coordinator

SCANDINAVIAN BIOPHARMA HOLDING AB
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.

€ 2 992 750,00
Address
INDUSTRIVAGEN 1
171 48 Solna
Sweden

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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
Östra Sverige Stockholm Stockholms län
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.

€ 2 992 750,00
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