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P53-SLP vaccine in combination with Imiquimod or IFNα

ABSTRACT: Primary objectives: The primary objective of the study is to assess whether the administration of p53-SLP together with the local application of imiquimod or the injection of interferon-alfa is safe and able to induce an immune response specific to p53. Primary endpoints: Safety will be assessed during the whole study by collecting all adverse events (with a focus on administration site reactions), vital signs, blood-chemistry and haematological parameters. Immunogenicity will be assessed by an array of complementary immunological assays which focus on p53-specific T-cell proliferation, enumeration of circulating IFNγ-producing T-cells, Th1/Th2 cytokine production, and p53 protein recognition by circulating and vaccine-site-homing T-cells.

DISEASE(S): Adult Both Male And Femal Patients Treated For Colorectal Cancer

PROVIDER: 2524913 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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