Study of the MUC1 Peptide - Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Evaluate the immune response to MUC1 peptide vaccine administered with Poly-ICLC, measured by Anti MUC1 antibody, in patients with a history of advanced colorectal adenoma.
52 weeks
Yes
Robert E Schoen
Principal Investigator
University of Pittsburgh
United States: Food and Drug Administration
PRO07030214
NCT00773097
October 2008
October 2012
Name | Location |
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Digestive Disorders Clinic | Pittsburgh, Pennsylvania 15213 |