Descripción del proyecto
La primera vacuna oral contra la Escherichia coli enterotoxigénica
La bacteria Escherichia coli enterotoxigénica (ECET) es la causante de la diarrea del viajero, que afecta especialmente a la población de los países en desarrollo. La ECET se transmite a través de alimentos o agua contaminados y actualmente no existe ninguna vacuna aprobada para su prevención. Biopharma, en Suecia, está desarrollando una vacuna oral contra la diarrea del viajero asociada a la ECET. La empresa colabora con los principales expertos mundiales en investigación de vacunas contra la ECET. En el proyecto ETVAX, financiado con fondos europeos, se llevará a cabo un estudio de fase II de la vacuna que permitirá a Biopharma dar los pasos necesarios para su comercialización. El éxito de la introducción de la vacuna reducirá el número de casos de diarrea del viajero entre los viajeros afectados y los pacientes con síndrome del intestino irritable u otras enfermedades crónicas asociadas a esta enfermedad.
Objetivo
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.
Ámbito científico
Palabras clave
Programa(s)
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaConvocatoria de subcontratación
H2020-SMEINST-2-2016-2017
Régimen de financiación
SME-2 - SME instrument phase 2Coordinador
171 48 Solna
Suecia
Organización definida por ella misma como pequeña y mediana empresa (pyme) en el momento de la firma del acuerdo de subvención.