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Biomarkers For Enhanced Vaccine Safety

Objective

BioVacSafe is a concise consortium of selected academic, public, and SME participants used to co-working in industry-led projects, organised into focused Activity Cores to generate knowledge and tools to benchmark licensed vaccine reactogenicity, and create practical and generalizable guidelines and techniques to enhance immunosafety of novel vaccines from pre-development to post-marketing surveillance. A compact interlocking structure provides efficient and cost-effective goal delivery, while offering the full spectrum of functionality and capacity to match the needs for predictive biomarkers and models of inflammation/autoimmunity and clinical events classification. A Technology Core has transcriptomics, genotyping, proteomics, metabolomics and data mining, with depth and capacity to discover, validate and distribute novel biomarkers. A Models Core has a full range of ex vivo/in vivo murine, small animal and non-human primate models of inflammation and biomarker discovery, with advanced immunology and imaging. A Clinical Core has capability to safely and efficiently distribute clinical studies of vaccine immunosafety from small intensive trials to large-scale studies of adult, paediatric and other populations. A Populations Core has population-scale biobank discovery, clinical cohorts (with globalisation capability, autoimmune, chronic, inflammatory and infectious disease groups), large-scale genotyping and sequencing, and a safely accessible central database for online analyses of large datasets. A Regulatory Core with expertise to synthesise outputs to generate and disseminate classifications, guidelines, reference standards for vaccine development, and inform EFPIA activities. A Management Core with track record of successful public-private projects ensures Cores interoperate to maximise discovery - validation - application - re-discovery cycles, to deliver project goals on time, within budget, while maximising interactions with other actors (EFPIA, FDA, EMA).
Leaflet | Map data © OpenStreetMap contributors, Credit: EC-GISCO, © EuroGeographics for the administrative boundaries

Coordinator

GLAXOSMITHKLINE VACCINES SRL

Address

Via Fiorentina 1
53100 Siena

Italy

Activity type

Private for-profit entities (excluding Higher or Secondary Education Establishments)

Administrative Contact

Participants (21)

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UNIVERSITY OF SURREY

United Kingdom

EU Contribution

€ 3 808 116

MAX-PLANCK-GESELLSCHAFT ZUR FORDERUNG DER WISSENSCHAFTEN EV

Germany

EU Contribution

€ 2 451 932

LIVERPOOL SCHOOL OF TROPICAL MEDICINE

United Kingdom

EU Contribution

€ 216 203

COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES

France

EU Contribution

€ 399 999

IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE

United Kingdom

EU Contribution

€ 2 336 660

UNIVERSITA DEGLI STUDI DI SIENA

Italy

EU Contribution

€ 1 029 564

ImmunArray Ltd

Israel

EU Contribution

€ 925 820

CHALMERS TEKNISKA HOEGSKOLA AB

Sweden

EU Contribution

€ 762 212

Public Health England an Executive Agency of the Dept of Health

United Kingdom

EU Contribution

€ 566

UNIVERSITEIT UTRECHT

Netherlands

EU Contribution

€ 839 510

CHARITE - UNIVERSITAETSMEDIZIN BERLIN

Germany

EU Contribution

€ 356 306

UNIVERSITEIT GENT

Belgium

EU Contribution

€ 2 000 007

GOETEBORGS UNIVERSITET

Sweden

EU Contribution

€ 777 000

ISLENSK ERFDAGREINING EHF

Iceland

EU Contribution

€ 29 786

STATENS SERUM INSTITUT

Denmark

EU Contribution

€ 679 216

GLAXOSMITHKLINE BIOLOGICALS SA

Belgium

SANOFI PASTEUR SA

France

CDISC EUROPE FOUNDATION FONDATION

Belgium

VISMEDERI SRL

Italy

Department of Health

United Kingdom

EU Contribution

€ 497 736

ST GEORGE'S HOSPITAL MEDICAL SCHOOL

United Kingdom

EU Contribution

€ 315 031

Project information

Grant agreement ID: 115308

Status

Closed project

  • Start date

    1 March 2012

  • End date

    28 February 2018

Funded under:

FP7-JTI

  • Overall budget:

    € 30 998 646

  • EU contribution

    € 17 425 664

Coordinated by:

GLAXOSMITHKLINE VACCINES SRL

Italy