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VAC2VAC SIGNED

Vaccine lot to Vaccine lot comparison by consistancy testing - Sofia ref.: 115924

Total Cost €

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EC-Contrib. €

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Partnership

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Project "VAC2VAC" data sheet

The following table provides information about the project.

Coordinator
EUROPEAN VACCINE INITIATIVE EWIV 

Organization address
address: VOSSSTRASSE 2 GEB 4040
city: HEIDELBERG
postcode: 69115
website: http://www.euvaccine.eu/

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Germany [DE]
 Project website http://www.vac2vac.eu
 Total cost 16˙290˙929 €
 EC max contribution 7˙850˙000 € (48%)
 Programme 1. H2020-EU.3.1.7. (Innovative Medicines Initiative 2 (IMI2))
 Code Call H2020-JTI-IMI2-2015-03-two-stage
 Funding Scheme IMI2-RIA
 Starting year 2016
 Duration (year-month-day) from 2016-03-01   to  2021-02-28

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    EUROPEAN VACCINE INITIATIVE EWIV DE (HEIDELBERG) coordinator 1˙060˙437.00
2    MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT NL (DEN HAAG) participant 1˙078˙156.00
3    BUNDESINSTITUT FUR IMPFSTOFFE UND BIOMEDIZINISCHE ARZNEIMITTEL DE (LANGEN) participant 1˙000˙000.00
4    Department of Health UK (Leeds) participant 631˙405.00
5    UNIVERSITEIT UTRECHT NL (UTRECHT) participant 553˙000.00
6    OSTERREICHISCHE AGENTUR FUR GESUNDHEIT UND ERNAHRUNGSSICHERHEIT GMBH AT (WIEN) participant 512˙487.00
7    SCIENSANO BE (ELSENE) participant 505˙625.00
8    ISTITUTO SUPERIORE DI SANITA IT (ROMA) participant 500˙000.00
9    ASSOCIATION INTERNATIONALE DE STANDARDISATION BIOLOGIQUE POUR L'EUROPE (IABS-EU) FR (LYON) participant 493˙187.00
10    ACADEMISCH ZIEKENHUIS GRONINGEN NL (GRONINGEN) participant 400˙500.00
11    Stichting Hogeschool Utrecht NL (UTRECHT) participant 325˙000.00
12    STICHTING BIOMEDICAL PRIMATE RESEARCH CENTER NL (RIJSWIJK ZH) participant 305˙090.00
13    RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU NL (BILTHOVEN) participant 247˙464.00
14    JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION BE (BRUSSELS) participant 237˙647.00
15    AGENTSCHAP COLLEGE TER BEOORDELING VAN GENEESMIDDELEN NL (UTRECHT) participant 0.00
16    BOEHRINGER INGELHEIM VETMEDICA GMBH DE (INGELHEIM) participant 0.00
17    GLAXOSMITHKLINE BIOLOGICALS SA BE (RIXENSART) participant 0.00
18    INSTITUT SCIENTIFIQUE DE SANTE PUBLIQUE BE (BRUXELLES) participant 0.00
19    INTERVET INTERNATIONAL BV NL (BOXMEER) participant 0.00
20    MERIAL SAS FR (LYON) participant 0.00
21    PFIZER MANUFACTURING AUSTRIA GMBH AT (ORTH AN DER DONAU) participant 0.00
22    SANOFI PASTEUR SA FR (LYON) participant 0.00
23    ZOETIS BELGIUM SA BE (LOUVAIN LA NEUVE) participant 0.00

Map

 Project objective

Lot release testing of established vaccines relies on using animal models. Many of these models were developed decades ago and reflect the level of product knowledge, production technology and quality management in those days. Current production techniques are optimised, in-process control is implemented and tight quality management systems are in place. These developments have brought testing for lot-to-lot consistency into reach. The consistency approach involves the use of a set of parameters obtained by using innovative in vitro technologies, to define the product along the manufacturing pathway and to ensure similarity to a lot of proven efficacy and safety.

The ambition of the VAC2VAC project is a demonstrated proof of concept of the consistency approach for lot release testing. We will develop/optimise and validate innovative in vitro methods for the categories of established vaccines on the market. Product profiles will be defined using analytical methods, cell-based assays and bioinformatics.

The project includes 7 WPs: 4 on R&D, and one each on validation, promotion to regulatory acceptance and consortium management. Consortium partners represent the vaccine stakeholder groups (OMCLs, Academia, Translational research institutes and Vaccinology alliances) and are complementary for the expertise ranging from method development and validation to facilitating and providing guidance to regulatory acceptance. Acceptance will be promoted by strategic guidance activities: a roadmap conference, workshops and training courses. Implementation of the consistency approach in lot release testing has multiple impact: 1) strengthening fundamental understanding of vaccine products resulting in enhanced understanding of vaccine quality 2) strengthening competitiveness of European Vaccine Industries resulting in reduced QC costs and shortened QC time. 3) strengthening European animal welfare policies resulting in a substantial reduction in animal numbers for vaccine QC

 Deliverables

List of deliverables.
Project meetings and conferences. Other 2020-03-24 16:36:20
Establishment of SEAC. Other 2020-03-24 16:36:20
Preparation of communication material including launch of project webpage. Websites, patent fillings, videos etc. 2020-03-24 16:36:20

Take a look to the deliverables list in detail:  detailed list of VAC2VAC deliverables.

 Publications

year authors and title journal last update
List of publications.
2018 Marlies Halder, Hilde Depraetere, Frédérique Delannois, Arnoud Akkermans, Marie-Emmanuelle Behr-Gross, Martijn Bruysters, Jean-François Dierick, Carmen Jungbäck, Imke Kross, Bernard Metz, Jeroen Pennings, Peter Rigsby, Patrice Riou, Elisabeth Balks, Alexandre Dobly, Odile Leroy, Catrina Stirling
Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies
published pages: 78-82, ISSN: 1045-1056, DOI: 10.1016/j.biologicals.2018.01.003
Biologicals 52 2020-03-24

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The information about "VAC2VAC" are provided by the European Opendata Portal: CORDIS opendata.

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