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EMLI


Malaria

Phase-I and II Trials of the Malaria Pre-Erythrocytic Vaccine LSA-3 and Refinement  of Measurable Outcomes
Framework programme:
5
Project number:
QLK2-CT-2001-01886
EC contribution:
€ 1 462 733
Duration:
36 months
Type:
DM
Starting date:
1 January 2002

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.

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