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.

Agency
National Institute of Health (NIH)
Type
Station Support Contracts (N03)
Project #
261201200042I-0-26100003-1
Application #
8762914
Study Section
Project Start
2013-09-06
Project End
2016-01-05
Budget Start
Budget End
Support Year
Fiscal Year
2013
Total Cost
$939,452
Indirect Cost
Name
Mayo Clinic, Rochester
Department
Type
DUNS #
006471700
City
Rochester
State
MN
Country
United States
Zip Code
55905