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Immunotherapy of Prostate Cancer - Prostate Cancer Vaccine Clinical Trial

机译：前列腺癌的免疫治疗 - 前列腺癌疫苗临床试验

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At the pre-IND conference in 2000 it became clear that the initiation of the clinical trial was to be delayed due to new FDA regulations which required plasmid vectors with kanamycin instead of ampicillin resistance genes, and which discouraged the use of a recombinant adenoviral vector for boosting. This necessitated the development of practically new vaccines and, since the FDA required separate in vitro and in vivo testing, the research has focused on (a) development of the new vaccines; (b) gathering of in vitro data for their safety and efficacy and (c) development of in vivo model for their safety and efficacy. We developed a modified pcDNA3.1 vector that gives high expression in mammalian cells. Dendritic cells transfected with this vector prime to both dominant and subdominant epitopes. Immunization with a construct encoding a xenogeneic protein is superior in breaking tolerance to a self protein. Three immunizations with a cocktail containing the plasmid vaccine and recombinant GM-CSF provide excellent protection against tumor development in a rat model. These results have been incorporated in new IND application.

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