With this project two major vaccine companies in Europe, IRBM (Merck) and Chiron, join their efforts with several European groups and one institution from Egypt to develop efficacious preventative and therapeutic Hepatitis C (HCV) vaccines. IRBM, in collaboration with CEINGE, has been working on a promising gene based HCV vaccine candidate using adenoviral vectors for delivery. This vaccine elicits potent CD4+ and CD8+ T cell responses and protects vaccinated chimpanzees from acute and chronic infection against challenge with a heterologous virus. This vaccine candidate works by lowering viral replication, thus preventing chronic hepatitis. Chiron vaccine candidate consists in recombinant HCV glycoproteins, gpE1 and gpE2 associated to resemble to a pre-virion envelope structure. Protection against homologous and heterologous challenge, mediated by CD4+ T cell response and antibodies, was observed in experiments in chimpanzee using MF59 as adjuvant. This vaccine is already in phase 1 clincal trial. Both the adenoviral and E1E2 vaccine candidates have the potential to protect humans from a large number of viral strains. The main aims of this project is the standardization of the parameters to conduct comparable pre-clinical studies and clinical trials both for preventative and therapeutic vaccines to HCV. The activities proposed include: 1) immunological studies on the two vaccines alone and in combination, 2) safety and tolerability tests in animals for the adenoviral vaccine; 3) phase 1 trials for preventative and therapeutic applications with IRBM and with Chiron vaccine separately. In conclusion, this project will give to the European researchers the opportunity to test 2 promising HCV vaccines and to standardize the HCV vaccine trials becoming a benchmark study for any other similar study.
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