Risk for Colorectal Cancer Clinical Trial
Official title:
Study of the MUC1 Peptide - Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma
The purpose of this study is to evaluate the immune response to MUC1 - poly-ICLC vaccine, an
investigational or study vaccine. The MUC1 - poly-ICLC vaccine is being tested in persons
with a history of advanced adenomatous polyps, the precursor to colorectal cancer. The MUC1 -
poly-ICLC vaccine is being developed to prevent polyps from advancing into colon cancer and
to prevent polyps from recurring.
MUC1 is mucus that is normally present on the lining of the human colon. However, MUC1 is
expressed in a larger amount and in a modified form on adenomatous polyps and colorectal
cancer. These changes in MUC1 are thought to be part of the process of progression from
adenomas toward cancer. The goal of a vaccine is to help the immune system in the body
identify the changes in MUC1 that accompany the progression to cancer and eliminate the
abnormal cells that make abnormal MUC1.
This is a phase II trial designed to assess antibody and T cell responses to MUC1 vaccine among subjects at increased risk for colorectal cancer by virtue of a history of advanced adenoma. The primary objective is to evaluate the immunogenicity of a combination of the 100mer MUC1 peptide and adjuvant Poly-ICLC in boosting the immune response to MUC1. Among the secondary objectives is to determine if anti-MUC1 immunity, preexisting or vaccine induced, has an effect on the recurrence of polyps. Subjects with a history of advanced adenoma will be recruited for MUC1 vaccination. Vaccine will be administered at weeks 0, 2, and 10. Some subjects may have pre-existing immunity to MUC1, and this will be accounted for in the analytic phase. However, all subjects will be administered the vaccine, regardless of baseline antibody status. To insure accurate standardization in measurement and assessment of antibody levels, assays for baseline antibody status will be done at the same time as those for response to vaccine. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04038736 -
Evaluation C-Scan System in Providing Structural Information and Polypoid Lesions in the Colon of Healthy Subjects
|
N/A |