MUC1 Vaccine in Patients with Newly Diagnosed Advanced Adenomas

MUC1在腺瘤性息肉等癌前病变中过表达和低糖基化，并且随着不典型增生程度的升高，MUC1的表达量显著增加。MUC1在维持恶性表型中具有重要的功能。因此，在腺瘤性息肉患者等恶性前病变患者中，诱导针对MUC1的免疫应答，可以防止息肉复发以及进展为癌症。

MUC1 is overexpressed and hypoglycosylated on premalignant lesions such as adenomatous polyps, and its expression is significantly greater with higher degrees of dysplasia. MUC1 is functionally important in the maintenance of the malignant phenotype. Thus, induction of an immune response against MUC1 in the setting of premalignancy, such as in patients with adenomatous polyps, may protect from polyp recurrence as well as from progression to cancer. This is a randomized, double-blind, placebo controlled phase II trial designed to elicit immune responses to abnormal MUC1. There are 3 parts to this Phase II trial, but parts 2 and 3 are dependent on achieving the aims of part 1 (demonstration of an immune response to the vaccine). Although each part will provide salient independent data on MUC1 immunoprevention, but if the vaccine is not found to be immunogenic in part 1, then parts 2 and 3 will not be performed. Therefore, this statement of work only outlines the requirements for Part 1. If the aims of part 1 are achieved, a subsequent new statement of work will address parts 2 and 3.