MUC1 Vaccine in Patients with Newly Diagnosed Advanced Adenomas

MUC1在癌前病变如腺瘤性息肉中高表达和低糖基化，其表达随着不典型增生程度的增加而显著增加。MUC1在维持恶性表型方面具有重要的功能。因此，在癌前状态下，例如在腺瘤性息肉患者中，诱导针对MUC1的免疫反应可以防止息肉复发和癌症进展。 这是一项随机、双盲、安慰剂对照的II期试验，旨在诱导对异常MUC1的免疫反应。这项第二阶段试验分为三个部分，但第二部分和第三部分取决于实现第一部分的目标(展示对疫苗的免疫反应)。虽然每个部分都将提供有关MUC1免疫预防的显著独立数据，但如果在第一部分中发现疫苗没有免疫原性，则第二部分和第三部分将不会执行。因此，本工作说明书仅概述了第1部分的要求。如果实现了第1部分的目标，后续新的工作说明书将涉及第2部分和第3部分。

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.