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Standardization and Development of Assays for Assessment of Influenza Vaccines Correlates of Protection

Objective

Background: Influenza viruses cause annual epidemic and occasional pandemics, both of which induce significant morbidity and mortality. Influenza infections affect all age groups but children and adults over the age of 65 are at most risk of developing severe disease.
Vaccination is the most effective approach to reduce the impact of annual influenza outbreaks and potential pandemics, however, the currently criteria of correlates of protection(CoP) show limitations in predicting protection for seasonal and pandemic vaccines.
The Haemagglutinin Inhibition(HAI) antibody titre is the most widely used CoP for seasonal influenza vaccine even if there is a lack of standardisation for conducting HAI and other serological assays and therefore results obtained from different laboratories are not comparable. This leads to the urgent need of improving international standardisation of serological assays to reduce inter laboratory variability and to generate supportive immunological assays to be used in studies aimed at developing clinically relevant surrogate markers of protection of influenza vaccines.
Objectives: The main long-term aim of the FLUCOP project is to improve and standardize the existing immunological assays and to develop new assays for the better evaluation of the CoP of influenza vaccines.
Main specific FLUCOP objectives include:
- achieve standardization of HAI and Virus Neutralization(VN) assays;
- promote the understanding and application of Cell-Mediated Immunity (CMI) and Neuraminidase (NA) assays as tools for the evaluation of influenza vaccines;
- develop selective new assays which might potentially used for future clinical trials for influenza seasonal vaccine evaluation
FLUCOP Consortium and Project Impact: The FLUCOP consortium brings together 26 groups from 7 European countries, and includes contributors from the academic, governmental, non-for-profit and pharmaceutical sectors. As a whole, the consortium has a balanced array of expertise and each group has been carefully selected to avoid overlaps in research activities and to collectively address the planned objectives. FLUCOP is expected to have a significant impact to improve and standardize the existing immunological assays and develop new assays to better evaluate influenza vaccines. This will contribute to the future clinical trial evaluation and possible establishment of correlates of protection Through a public-private collaboration FLUCOP will reach a common agreement on assays and methods to be used by all groups both from the public and private sector for testing influenza vaccines in humans. These efforts are expected to aid evolution of the regulatory guidelines and the practice of the pharmaceutical industry following the application of the methods to efficacy studies.
Project plan: To reach the proposed objectives, the FLUCOP project is composed of five focused interconnected work packages(WP).
WP1:Standardization of HAI and VN assays.
Objective: HAI and VN assays are commonly used to quantify influenza specific antibodies but they show to be highly variable between laboratories. Moreover different protocols are in use in different laboratories, which may contribute to the variability of the assays. This WP aims to improve the standardization and harmonization of these assays and also preparation and qualification of critical reagents.
Methodology: Adult and paediatric pre and post influenza vaccination serum samples will be available to consortium partners who are recognized as leading experts in serological analysis of influenza vaccine responses. A target protocol profile will be developed jointly and statistically powdered studies will be design to compare, screen and evaluate consensus protocols. Sera will be analyzed in iterative rounds of testing of the empirically selected consensus protocols and assay conditions. A final data driven consensus protocol(s) for each HAI and VN format will agreed upon, based on the results o

Call for proposal

IMI-JU-10-2013
See other projects for this call

Coordinator

SANOFI PASTEUR SA
Address
14 Espace Henry Vallee
69007 Lyon
France
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Principal investigator
Patricia Londono-Hayes (DR.)
Administrative Contact
Mathilde Salavin (Madame)

Participants (21)

SCLAVO VACCINES ASSOCIATION
Italy
EU contribution
€ 856 730
Address
Piazza La Lizza 7
53100 Siena
Activity type
Research Organisations
Administrative Contact
Donata Medaglini (Professor)
UNIVERSITA DEGLI STUDI DI SIENA
Italy
EU contribution
€ 761 000
Address
Via Banchi Di Sotto 55
53100 Siena
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Massimo Ferri (Dr)
Department of Health
United Kingdom
EU contribution
€ 1 469 761
Address
Quarry House, Quarry Hill
LS2 7UE Leeds
Activity type
Research Organisations
Administrative Contact
Amanda King (Mrs)
BUNDESINSTITUT FUR IMPFSTOFFE UND BIOMEDIZINISCHE ARZNEIMITTEL
Germany
EU contribution
€ 552 006
Address
Paul-ehrlich-strasse 51-59
63225 Langen
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Michael Mann (-)
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Netherlands
EU contribution
€ 329 748
Address
Dr Molewaterplein 40
3015 GD Rotterdam
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Wim Leep (Mr.)
UNIVERSITETET I BERGEN
Norway
EU contribution
€ 697 000
Address
Museplassen 1
5020 Bergen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Liv-Grete Gudmundsen (Lear/Advisor)
UNIVERSITEIT GENT
Belgium
EU contribution
€ 320 024
Address
Sint Pietersnieuwstraat 25
9000 Gent
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ilona Stoffels (Ms)
FONDAZIONE IRCCS CA' GRANDA - OSPEDALE MAGGIORE POLICLINICO
Italy
EU contribution
€ 156 700
Address
Via Francesco Sforza 28
20122 Milano
Activity type
Other
Administrative Contact
Giuseppina Verga (Prof)
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
EU contribution
€ 117 009
Address
Wellington Square University Offices
OX1 2JD Oxford
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Gill Wells (Ms)
QUINTEN
France
EU contribution
€ 130 000
Address
Galvani
75017 Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Alexandre Templier (Dr)
EUROPEAN VACCINE INITIATIVE EWIV
Germany
EU contribution
€ 150 000
Address
Vossstrasse 2 Geb 4040
69115 Heidelberg
Activity type
Research Organisations
Administrative Contact
Odile Leroy (Dr)
STICHTING BIOMEDICAL PRIMATE RESEARCH CENTER
Netherlands
EU contribution
€ 130 000
Address
Lange Kleiweg 161
2288 GJ Rijswijk Zh
Activity type
Research Organisations
Administrative Contact
Willem Slingerland (Mr)
ISTITUTO SUPERIORE DI SANITA
Italy
EU contribution
€ 250 020
Address
Viale Regina Elena 299
00161 Roma
Activity type
Research Organisations
Administrative Contact
Rosa Maria Martoccia (Dr.ssa)
UNIVERSITY OF SURREY
United Kingdom
EU contribution
€ 40 000
Address
Stag Hill
GU2 7XH Guildford
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Maria Sega-Buhalis (Mrs)
ARTEMIS BIO-SUPPORT B.V.
Netherlands
EU contribution
€ 100 000
Address
Molengraaffsingel 10
2629 JD Delft
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Eric Claassen (Professor)
THE EUROPEAN MEDICINES AGENCY
Netherlands
EU contribution
€ 40 002
Address
Domenico Scarlattilaan 6
1083 HS Amsterdam
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Guido Rasi (Dr)
GLAXOSMITHKLINE VACCINES SRL
Italy
Address
Via Fiorentina 1
53100 Siena
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Francesco Gulli (Admin)
GLAXOSMITHKLINE BIOLOGICALS SA
Belgium
Address
Rue De L Institut 89
1330 Rixensart
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Nives Povrzenic (Admin)
JANSSEN VACCINES & PREVENTION BV
Netherlands
Address
Archimedesweg 4
2333 CN Leiden
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Stefan Kostense (Director)
ABBOTT BIOLOGICALS BV
Netherlands
Address
C.j. Van Houtenlaan 36
1381 CP Weesp
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Astrid v. Perbandt (Dr.)
ASTRAZENECA AB
Sweden
Address
Vastra Maelarhamnen
151 85 Sodertaelje
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Eva Lindgren (Senior Director)