Obiettivo
Twenty years after the discovery of human immunodeficiency virus (HIV)as the causative agent of the acquired immune deficiency syndrome (AIDS) a vaccine to prevent virus infection or mitigate disease is still not available. Accumulating data suggest that CD8-positive T cells play an important role in the control of HIV in the infected host. Therefore, several vaccine strategies based on DNA or recombinant viral or bacterial vectors have been devised to induce this type of immune response, and some of th ese vaccines are in early clinical testing. This proposal aims at demonstrating the safety and immunogenicity in humans of a novel recombinant measles virus (MV) vector for use as an AIDS vaccine. The vector is replication competent in vivo and is deriv ed from a widely used measles vaccine strain (Schwarz), which is known to induce very long lasting immunity. Therefore, this novel vector potentially offers a unique combination of safety and potency. The recombinant HIV MV vectors will express three re latively conserved HIV proteins (Gag, Pol, Nef) from HIV clade B and A strains. A good manufacturing practices (GMP) compatible production process for the recombinant MV vector will be developed and a GMP lot will be produced for two clinical studies. Th e first study will evaluate the safety profile of the MV vector, while the second study will assess in addition the immunogenicity in MV-immune volunteers. With these two clinical studies, the project will specifically address potential shedding of the r ecombinant vector into the environment and the potential negative impact of pre-existing MV immunity. It is expected that at the end of the project sufficient clinical data on the safety and immunogenicity will have been generated to decide on subsequent advanced technical and clinical development of this novel vaccine approach.
Campo scientifico
- natural sciencesbiological sciencesmicrobiologyvirology
- natural sciencesbiological sciencesgeneticsDNA
- medical and health sciencesbasic medicineimmunology
- medical and health scienceshealth sciencesinfectious diseasesRNA virusesHIV
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccines
Invito a presentare proposte
FP6-2004-LIFESCIHEALTH-5
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Meccanismo di finanziamento
IP - Integrated ProjectCoordinatore
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