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TOWARDS SAFE AND EFFECTIVE IMMUNOTHERAPY OF PERSISTENT LIFE-THREATENING FOOD ALLERGIES

Objective

The FAST project aims at the development of safe and effective treatment of food allergies. It targets persistent and severe allergy to fish and fruit. Besides persistence and severity, this choice is based on prevalence and the importance of these foods for a healthy diet. Classical allergen-specific immunotherapy (SIT) for treatment of food allergy using subcutaneous injections with food extracts has proven to be effective but too dangerous due to anaphylactic side-effects. FAST will therefore develop a safe alternative by replacing food extracts with hypo-allergenic recombinant major allergens, the active ingredients of SIT. Both severe fish and fruit allergy are caused by a single major allergen, parvalbumin for fish and lipid transfer protein for fruit. This makes development of a novel biotechnological product feasible. Two approaches will be evaluated for achieving hypoallergenicity, i.e. site-directed mutagenesis and chemical modification. The most promising hypo-allergenic versions of parvalbumin and lipid transfer protein will be produced under GMP conditions. After pre-clinical testing (toxicology testing and efficacy in mouse models), Phase I and II randomized double-blind placebo-controlled multi-center clinical trials will be performed. Two routes of administration will be evaluated, subcutaneous in case of fish and sublingual in case of fruit. The primary read-out will be the double-blind placebo-controlled food challenge. To understand the underlying immune mechanisms of subcutaneous and sublingual immunotherapy, these trials will be accompanied by in depth serological and cellular immune analyses, allowing identification of novel biomarkers for monitoring treatment efficacy. FAST will improve the quality of life of food allergic patients by providing a safe and effective curative treatment that will end their dependence on avoidance and rescue medication.

Field of science

  • /medical and health sciences/clinical medicine/allergology/food allergy
  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmaceutical drug
  • /medical and health sciences/basic medicine/immunology/immunotherapy
  • /agricultural sciences/agriculture, forestry, and fisheries/agriculture/horticulture/fruit
  • /medical and health sciences/clinical medicine/allergology
  • /medical and health sciences/basic medicine/toxicology

Call for proposal

FP7-HEALTH-2007-A
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM
Address
Meibergdreef 15
1105AZ Amsterdam
Netherlands
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 573 531,71
Administrative Contact
Richard De Loor (Mr.)

Participants (18)

MEDIZINISCHE UNIVERSITAET WIEN
Austria
EU contribution
€ 270 403,50
Address
Spitalgasse 23
1090 Wien
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Otto Scheiner (Prof.)
QUADRAM INSTITUTE BIOSCIENCE
United Kingdom
EU contribution
€ 417 654
Address
Quadram Institute Bioscience Norwich Research Park
NR4 7UQ Norwich
Activity type
Research Organisations
Administrative Contact
Mary Anderson (Dr.)
SERVICIO MADRILENO DE SALUD
Spain
EU contribution
€ 96 214,40
Address
Plaza Carlos Trias Bertran 7
28020 Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
José Francisco Soto Bonel (Mr.)
REGION SYDDANMARK
Denmark
EU contribution
€ 86 132,10
Address
Damhaven 12
7100 Vejle
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Peter Frandsen (Dr.)
PROVINCIA ITALIANA DELLA CONGREGAZIONE DEI FIGLI DELLA IMMACOLATA CONCEZIONE

Participation ended

Italy
EU contribution
€ 42 512,28
Address
Via Della Luce 46
00153 Roma
Activity type
Research Organisations
Administrative Contact
Adriano Mari (Dr.)
UNIVERSYTET MEDYCZNY W LODZI.
Poland
EU contribution
€ 64 013,62
Address
Al. Kosciuszki, 4
90419 Lodz
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Katarzyna Bieniek (Ms.)
ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON
Greece
EU contribution
€ 168 853,50
Address
6 Christou Lada Str
10561 Athina
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Maria Chatzara (Ms.)
LANDSPITALI UNIVERSITY HOSPITAL
Iceland
EU contribution
€ 103 392,32
Address
Eiriksgata 5
101 Reykjavik
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Eyrun Steinsson (Ms.)
HAL ALLERGY BV
Netherlands
EU contribution
€ 112 891,55
Address
J H Oortweg 15
2333 CH Leiden
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Henk Naaktgeboren (Mr.)
BIAL INDUSTRIAL FARMACEUTICA S.A.
Spain
EU contribution
€ 42 003,93
Address
Alameda Urquijo 27
48008 Bilbao
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Inigo Pagoaga Izurrategui (Mr.)
BIOMAY AG
Austria
EU contribution
€ 181 607,62
Address
Lazarettgasse 19
1090 Wien
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Angela Neubauer (Dr.)
REFLAB APS

Participation ended

Denmark
EU contribution
€ 7 788,75
Address
Tagensvej 20
2200 Koebenhavn
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Eva Valbjorn Sorensen (Prof)
COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES
France
EU contribution
€ 62 461
Address
Rue Leblanc 25
75015 Paris 15
Activity type
Research Organisations
Administrative Contact
Eliane Deck-Chaumont (Ms.)
REGION HOVEDSTADEN
Denmark
EU contribution
€ 345 352,08
Address
Kongens Vaenge 2
3400 Hillerod
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Tine Green (Ms.)
PARIS-LODRON-UNIVERSITAT SALZBURG
Austria
EU contribution
€ 101 215
Address
Kapitelgasse 4-6
5020 Salzburg
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Gabriele Gadermaier (Dr.)
SERVICIO ANDALUZ DE SALUD
Spain
EU contribution
€ 121 680
Address
Avenida De La Constitucion 18
41071 Sevilla
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Elena Martín Bautista (Dr.)
UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Netherlands
EU contribution
€ 63 069,64
Address
Heidelberglaan 100
3584 CX Utrecht
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Antoinette Van Der Linden (Mrs.)
CLINICAL TRIAL CENTER MAASTRICHT
Netherlands
EU contribution
€ 132 975
Address
Oxfordlaan 70
6229 EV Maastricht
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Carl De Bont (Dr.)