Obiettivo
Vaccines based on viral structural products (Env/Gag/Pol) alone have failed to prevent infection by HIV/SIV. Vaccines based on viral regulatory gene products (Tat/Rev/Nef) have contained virus replication preventing disease onset.A vaccine combining both (combined vaccine) is likely to be superior to the formers since it induces immune responses targeting both early and late viral products. The mission of AVIP is to develop novel preventive and therapeutic vaccines to be tested in phase I trials in Europe, that are suitable for future testing in phase II/III trials in Developing Countries (DC), and to foster training, technology transfer and community involvement among EU and DC.
To ensure completion of the program, priority has been given to vaccine combinations containing single antigens that are already approved for human use and in phase I studies and with proven efficacy in animal models.Therefore AVIP specific objectives are to conduct:
1.Preventive and therapeutic phase I trials in Europe with 4 novel combined vaccines. These will be first tested in preclinical models to optimise the formulation and the vaccination protocols, and then will enter phase I trials.
2.Feasibility studies and technology transfer in DC for future phase II/III trials within the European and Developing Countries Clinical Trials Programme (EDCTP).
3.Training in EU countries and DC. To this goal, the AVIP International School will be established.
4.Community involvement both in EU countries and DC to ensure the correct ethical information of the volunteers, counselling, quality of life evaluation and risk assessment. AVIP objectives will be implemented by an ad hoc management structure which will oversees the science, training, business and administrative activities of AVIP.
Campo scientifico
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Argomento(i)
Invito a presentare proposte
FP6-2002-LIFESCIHEALTH
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