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TB-VAC
TUBERCULOSIS
Framework programme: 6
Call: 1
Project number:
LSHP-CT-2003-503367
EC contribution: € 17 000 000
Duration: 60 months
Type: IP
Starting date: 1 January 2004
Graphic element TB-VAC: An Integrated Project for New Vaccines against Tuberculosis
Keywords: Tuberculosis; integrated project; developing countries; vaccine development; phase I clinical trials; correlates of protection vaccine discovery; dormancy; immune markers; antigens; live vaccines; sub-unit vaccines; prime boost strategies

Summary:

Tuberculosis (TB) remains a leading cause of morbidity and mortality worldwide, accounting for more than 2 million human lives every year. The overall goal of the TB-VAC is to establish a joint academic-industrial consortium capable of taking tuberculosis vaccine candidates from the laboratory bench to phase I clinical trials.

Background:

TB is a leading infectious killer of adults in the world, causing about 2 million deaths a year, about 98% in developing countries. In these countries, the HIV pandemic has a strong impact on TB, resulting in an additional 1 million deaths per year. However, with the rise in drug-resistant strains of the disease, TB could once again become a major threat to Europe. Prevention through vaccination could be the most effective intervention but, as yet, no vaccine effective against TB in the adult population is available.

In recent years, several promising new vaccine strategies have been developed, particularly in the context of the Fifth Framework Programme (FP5) project TB Vaccine Cluster. The Sixth Framework programme (FP6) TB-VAC project, with a budget of € 16.8 million, aims to integrate the European efforts towards the development of novel tuberculosis vaccine candidates and forward these vaccines to small scale, phase I human clinical trials in Europe and Africa. Under the coordination of Animal Sciences Group in Lelystad, The Netherlands, the project joins 31 leading European institutions from nine European and two African countries, including two major vaccine producers.

Aim:

The main goals of TB-VAC integrated project are:

  • the discovery and development of new, promising tuberculosis vaccine candidates effective in the young adult population
  • the development of tests that predict vaccine efficacy in humans
  • the clinical evaluation of lead candidates in small initial trials in Europe and Africa
  • capacity building in developing countries for clinical evaluation of vaccines
  • liaise with other consortia (e.g. MUVAPRED) to coordinate specific activities
  • liaise with the European and Developing Countries Clinical Trials Partnership (EDCTP) to enable further large clinical trials in African Countries.

Expected results/Potential applications:

The TB-VAC project will deliver the following results via two tracks.

Track 1. Optimisation of existing vaccine candidates towards phase I trials:

Strategic development:

  • production of new and selected vaccines will be optimised by combining the best delivery system/adjuvant available with the best antigen or antigens known
  • definition of robust correlates of protective immunity against M. tuberculosis and surrogate markers of TB disease for monitoring and developing effective TB vaccines
  • evaluation of the efficacy of various selected vaccine candidates and their associated responses to mycobacteria and various mycobacterial components.

These results should allow the selection of a second generation of improved vaccines for clinical assessments in the downstream development component.

Downstream development:

  • production in Europe of promising candidate vaccines according to international quality requirements for production
  • establishment of a complete pre-clinical file to satisfy national and European regulatory authorities (RA)
  • establishment of vertical product development teams (PDT) for the most promising candidate-vaccines to ensure full communication and continued professional efforts from the upstream vaccine development down to clinical trials
  • phase I clinical trials designed and conducted in three European centres in areas of low TB endemicity and, later, in three centres of excellence in endemic areas in Africa.

The results of these studies may allow the selection of vaccines that may be further clinically developed in phase II trials (for example via European and Developing Countries Clinical Trials Partnerships).

Track 2. New vaccines/antigen discovery:
  • optimisation of live vaccines previously identified with an efficacy better than BCG
  • discovery of new immuno-modulatory ligands for improved vaccine efficacy
  • new candidate sub-unit antigens with a major focus given to dormancy/latency-associated antigens, the latter group being of particular interest.

Selected vaccine antigens (those with efficacies as good as BCG) will be optimised (particularly by combining selected antigens) and evaluated for efficacy in track 1.

Coordinator:

Jelle Thole
Division of Infectious Diseases, Animal Sciences Group
Edelhertweg 15
8219 PH Lelystad
The Netherlands
Tel: +31 320 238508
Fax: +31 320 238961
E-mail: jelle.thole@wur.nl
Website: http://www.asg.wur.nl

Paul Lambert
Tel: +41 22 3795783
Fax: +41 22 379 5801
E-mail: paul.lambert@medecine.unige.ch

Partners:

Principal
Scientific
Participants
Official Address Other Information
3F. MascartUniversité Libre de Bruxelles (ULB)
Avenue Franklin Roosevelt 50
BE-1050 Brussels
Belgium
Tel: +32 2 555 3467
Fax: +32 2 555 4499
E-mail: fmascart@ulb.ac.be
4P. MettensGSK Biologicals (GSK-Bio)
Rue de l’Institut
BE-1330 Rixenart
Belgium
Tel: +32 2 656 6659
Fax: +32 2 6567279
E-mail: pascal.mettens@gsk.com
5P. AndersenStatens Serum Institut (SSI)
Artillerivej 5, 81/307
DK-2300 Copenhagen
Denmark
Tel: +45 326 83 480
Fax: +45 3268 3035
E-mail: pa@ssi.dk
6H. Engers
Armauer Hansen Research Institute (AHRI)
PO Box 1005
Addis Ababa
Ethiopia
Tel: +251 171 02 88
E-mail: engersh@ahrialert
engersh@who.int
7M. Daffé
G. Puzo
F. Altare
Centre National de la Recherche
Scientifique (CNRS)
3 Rue Michel-Ange
FR-75794 Paris 16
France
Tel: +33 5 61 17 55 45
Fax: +33 5 61 17 59 94
E-mail: daffe@ipbs.fr
Tel: +33 5 61 17 55 04
E-mail: germain@ipbs
Tel: +33 5 61 33 60 00
E-mail: altare@ipbs.fr
8C. Locht
J-J Fournie
M. Bonneville
Institut National de la Santé et
de la Recherche Médicale (INSERM)
101, Rue de Tolbiac
FR-75654 Paris 13
France
Tel: +33 6 62 74 83 64
E-mail: camille.locht@pasteur-lille.fr
Tel: +33 5 62 74 83 64
Fax: +33 5 62 74 83 86
E-mail: fournie@toulouse.inserm.fr
Tel: +33 2 40 08 47 47
E-mail: bonnevil@nantes.inserm.fr
9J. WestermannUniversity Lübeck (UNILU)
Ratzeburger Allee 160
DE-23538 Lübeck
Germany
Tel: +49 451 500 4000
Fax: +49 451 500 4034
E-mail: westermann@anat.mu-luebeck.de
10S. StengerUniversity of Erlangen (IKM)
Wasserturmstrasse 3
DE-91054 Erlangen
Germany
Tel: +49 913 185 23647
Fax: +49 913 185 22282
E-mail:steffen.stenger@mikrobio.med.uni-erlangen.de
11H. Wagner
R. Lang
Technical University of Munich (TUM)
Trogerstrasse 4a
DE-81675 Munich
Germany
Tel: +49 894 140 7453
Fax: +49 894 140 7461
E-mail: h.wagner@lrz.tu-muenchen.de
Tel: +49 894 140 7453
E-mail: Roland.lang@lrz.tu-muenchen.de
12PS. KaufmannMax–Planck Institute for Infection Biology
(MPIIB)
Hofgartenstrasse 8
DE-80084 Munich
Germany
Tel: +49 302 846 0500
Fax: +49 302 846 0501
E-mail: kaufmann@mpiib-berlin.mpg.de
13F. PocciaNational Institute for Infectious Diseases
(INMILS)
Lazzaro Spallanzani
Via Portuense, 292
IT-00149 Rome
Italy
Tel: +39 06 55 170 904
Fax: +39 06 55 170 904
E-mail:
poccia@uniroma2.it
poccia@inmi.it
14F. DieliUniversity of Palermo
Via Divisi 83
IT-90133 Palermo
Italy
Tel: +39 09 16 555 916
Fax: +39 09 16 555901
E-mail: dieli@unipa.it
15S. MboupHôpital Le Dantec
BP 7325
Dakar
Senegal
Tel: +221 8216420
Fax: +221 8216442
E-mail:
mboup@eci.harvard.edu
et virus@sentoo.sn
16C. MartinUniversidad de Zaragoza Facultad de Medicina (UNIZAR)
C/Domingo Miral sn
ES-50009 Zaragoza
Spain
Tel: +34 976 761 759
Fax: +34 976 761 664
E-mail: carlos@unizar.es
17F. SallustoInstitute for Research in Biomedicine (IRB)
Via Vincenzo Vela 6
CH-6500 Bellinzona
Switzerland
Tel: +41 918 200 315
Fax: +41 918 200 312
E-mail: f.sallusto@irb.unisi.ch
18C.A. SiegristUniversity of Geneva
1 Michel Servet
CH-1211 Geneva 4
Switzerland
Tel: +41 22 379 5778
Fax: +41 22 379 5801
E-mail:
claire-anne.siegrist@medecine.unige.ch
19G. De LiberoUniversity Hospital of Basel (UNIBA-CH)
Hebelstrasse 20
CH-4031 Basel
Switzerland
Tel: +41 61 265 2327
Fax: +41 61 2652350
E-mail: Gennaro.DeLibero@unibas.ch
20F. SpertiniCentre Hospital Universitaire Vaudois (CHUV)
Rue de Bugnon 46
CH-1011 Lausanne
Switzerland
Tel: +41 213 140 799
Fax: +41 213 140 791
E-mail: francois.spertini@chuv.hospvd.ch
21B. Gicquel
S. Cole
Institut Pasteur (IPAS)
25-28, rue du Roux
FR-75724 Paris cedex 15
France
Tel: +33 1 45 68 88 28
Fax: +33 1 45 68 88 43
E-mail:
bgicquel@pasteur.fr
stcole@pasteur.fr
22T. OttenhoffLeiden University Medical Center (LUMC)
Albinusdreef 2
NL-2300 RC Leiden
The Netherlands
Tel: +31 71 526 5128
Fax: +31 71 521 6751
E-mail: t.h.m.ottenhoff@lumc.nl
23A. Thomas
F. Verreck
Biomedical Primate Research Center (BPRC)
Lange Kleiweg 139
NL-2288 GJ Rijswijk
The Netherlands
Tel: +31 15 2842640
Fax: +31 15 2843986
E-mail: thomas@bprc.nl
Tel: +31 15 284 2699
E-mail: verreck@bprc.nl
24R. BrookesMRC The Gambia (MRC)
P.O. Box 273
Banjul
The Gambia
Tel: +220 449 4072 Ext 425
Fax: +220 449 6513
E-mail: rbrookes@mrc.gm
25G.S. BesraUniversity of Birmingham (BHAM)
Edgbaston
UK-B15 2TT Birmingham
United Kingdom
Tel: +44 121 415 8125
Fax: +44 121 414 5925
E-mail: g.besra@bham.ac.uk
26Y. PerrieAston University (ASTON)
Aston Triangle
UK-B4 7ET Birmingham
United Kingdom
Tel: +44 121 359 3611
E-mail: Y.Perrie@aston.ac.uk
27E. BellManchester University Medical School (MANU)
Oxford Road
UK-M13 9PL Manchester
United Kingdom
Tel: +44 161 275 5237
E-mail: eric.bell@man.ac.uk
28B.D. RobertsonImperial College of Science, Technology and Medicine (ICSTM)
Exhibition Road
UK-SW7 2AZ London
United Kingdom
Tel: +44 207 559 43198
Fax: +44 207 594 3095
E-mail: b.robertson@imperial.ac.uk
29K.B. WalkerNational Institute for Biological Standards and Control (NIBSC)
Blanche Lane
South Mimms
UK-EN6 3QG Potters Bar
United Kingdom
Tel: +44 170 764 1473
Fax: +44 170 765 0223
E-mail: kbwalker@nibsc.ac.uk
30A.V.S. HillUniversity of Oxford (UOXF)
Wellington Square
UK-OX1 2JD Oxford
United Kingdom
Tel: +44 186 522 2301
Fax: +44 186 522 1921
E-mail: adrian.hill@imm.ox.ac.uk
31H. DockrellLondon School of Hygiene and Tropical Medicine (LSHTM)
Keppel Street
UK-WC1E 7HT London
United Kingdom
Tel: +44 20 7927 2466
Fax: +44 20 7927 2666
E-mail: Hazel.Dockrell@lshtm.ac.uk
32A. RawkinsHealth Protection Agency Porton Down (HPA PD)
Porton Down
UK-SP40JG Salisbury
United Kingdom
Tel: +44 1980 612100
Fax: +44 1980 612731
E-mail: Ann.RAWKINS@hpa.org.uk
31Gregory Dudley HUSSEY University of Cape Town
Institute of Infectious Diseases and Molecular Medicine
Werner & Beit Building
Faculty of Health Sciences,
University of Cape Town
Anzio Road, Observatory
7925 Cape Town
SOUTH AFRICA
Tel: +27-21-4066738 / +27-82-8863191
Fax: +27-21-6505192
E-mail: ghussey@rmh.uct.ac.za

 
 
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