MUC1 Vaccine in Patients with Newly Diagnosed Advanced Adenomas

MUC1 疫苗用于新诊断的晚期腺瘤患者

• 批准号: 9200918
• 负责人: PAUL LIMBURG
• 金额: $ 0.3万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-06 至 2017-01-05
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9200918
• 关键词: Address; Adenomatous Polyps; Adjuvant; Adverse event; Antibodies; Data; Double-Blind Method; Dysplasia; Immune response; Lesion; Maintenance; Malignant Neoplasms; Mucin 1 protein; Myelogenous; Newly Diagnosed; Participant; Patients; Peptide Vaccines; Placebo Control; Placebos; Polyps; Premalignant; Randomized; Recording of previous events; Recurrence; Suppressor-Effector T-Lymphocytes; Vaccinated; Vaccines; Work; adenoma; immunogenic; immunogenicity; malignant phenotype; overexpression; phase II trial; trial design

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.

MUC1过表达并在诸如腺瘤息肉等预抗病变上进行过度糖基化，并且其表达在较高的发育异常下明显更大。 MUC1在维持恶性表型中在功能上很重要。因此，在预日志的情况下，例如在腺瘤息肉患者中诱导对MUC1的免疫反应，可能会免受息肉复发，并免受癌症的进展。 这是一项随机，双盲，安慰剂控制的II期试验，旨在引起对异常MUC1的免疫反应。该II期试验有3个部分，但是第2部分和第3部分取决于实现第1部分的目的（证明对疫苗的免疫反应）。尽管每个部分都会提供有关MUC1免疫预防的显着数据，但是如果未发现该疫苗在第1部分中具有免疫原性，则不会进行第2部分和第3部分。因此，此工作声明仅概述了第1部分的要求。如果达到第1部分的目的，则随后的新工作声明将解决第2部分和第3部分。