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EMLI
MALARIA
Framework programme: 5
Project number:
QLK2-CT-2001-01886
EC contribution: € 1 462 733
Duration: 36 months
Type: DM
Starting date: 1 January 2002
Graphic element Phase-I and II Trials of the Malaria Pre-Erythrocytic Vaccine LSA-3 and Refinement  of Measurable Outcomes
Keywords: Vaccination; P. falciparum; liver stage

Summary:

This proposal is based upon a decade of European-sponsored research, which led to the rational identification, characterisation and demonstration of protection in chimpanzees by LSA3. It aims at testing, in phase I and conditional phase II trials, the protective effect demonstrated in the primate that is genetically 98% similar to humans. Besides safety and immunogenicity, it includes a unique approach to the understanding of critical mechanisms of defence in the liver, aimed at improving surrogates to guide future vaccine development. Three novel vaccine delivery systems will be used: Lactococcus lactis recombinant protein in the new SBAS2 adjuvant from SB Bio, DKA immunisation with the Aventis Pasteur licensed Vical vector, lipopeptide immunisation without adjuvant, which is yet another recent European discovery. It is performed with the expert guidance of the two leading vaccine industries.

Objectives:

The objectives of this project are:
1) to perform phase I clinical trials with a conditional challenge using three vaccine formulations derived from the P. falciparum Liver Stage Antigen 3
2) to identify better the surrogate markers of protection by a thorough immunological and biological analysis of volunteers’ sera and lymphocytes.

Description:

This proposal is the outcome of more than a decade of European-sponsored research, which led to the rational identification, characterisation and demonstration of protection in chimpanzees of LSA-3. It aims at testing, in phase I and phase II, a conditional challenge of phase I volunteers, the protective effect previously demonstrated in the only animal 98.4 % homologous to human beings. Besides safety and immunogenicity, it includes a unique approach aimed at improving surrogates to guide future vaccine development.  It relies not only on a new rationally chosen molecule, but also on three novel vaccine delivery systems, namely Lactococcus lactis recombinant protein in the recently developed SDAS2 adjuvant from GSK, DNA immunisation with the Aventis Pasteur’s licensed vical vector, lipopetide immunisation without adjuvant, yet another recent European discovery.  It is performed with the expert guidance of the two leading vaccine industries.

Coordinator:

Pierre Druilhe
Unité de Parasitologie Biomédicale, Institut Pasteur
25-28 rue du Dr Roux,
75724 Paris Cédex 15
France
Tel: +33 1 45 68 85 78
Fax: +33 1 45 68 86 40
E-mail: druilhe@pasteur.fr
Website: http://www.pasteur.fr

Partners:

Principal
Scientific
Participants
Official Address Other Information
2Joe CohenGlaxo SmithKline Biologicals s.a.
rue de l’Institut 89
BE-1330 Rixensart, Belgique
Tel: +32 2 656 8331
E-mail: cohen@sbbio.be
3Robert SauerweinAfd. Medische Parasitologie
Stichting Katholieke Universiteit
Geert Grooteplein Zuid 22
NL-6500 HB Nijmegen
The Netherlands
Tel: +31 24 361 0577
E-mail: R.Sauerwein@mmb.umcn.nl
4Laurent ReniaInstitut Cochin
Head, Immunohepatology Group
Co-director, Department of Immunology
INSERM U567, CNRS UMR 8104
Hopital Cochin
Bat Gustave Roussy,
27 rue du Faubourg Saint Jacques
FR-75014 Paris
France
Tel: +33 1 40 51 65 90
Fax: +33 1 40 51 65 02 or 35
E-mail:renia@cochin.inserm.fr
5Giampietro CorradinInstitut de Biochimie – Université de Lausanne
Chemin des Boveresses
Epalinge
CH-1000 Lausanne
Switzerland
Tel: +41 21 692 57 31
Fax: +41 21 692 57 05
E-mail: Giampietro.Corradin@IB.UNIL.CH
6Socrates HerreraFundacion Centro de Primates
Faculty of Health
Universidad del Valle
AA 2188
Cali
Colombia
Tel: +572 558 3937
E-mail: sherrera@inmuno.org
7Mr Nicholas Havelange – Mr Cedric DelsemmeHenogen S.A.
12 rue des Professeurs Jeener et Brachet
BE-6041 Charleroi
Belgium
Tel: +32 2 650 9792 / +32 7 137 8782
Fax: +32 7 137 8973
E-mail: cedric.delsemme@henogen.com

 
 
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