Trial Outcomes & Findings for Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma (NCT NCT00773097)

Results Overview

Evaluation of 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

52 weeks

Results posted on

2019-01-07

Participant Flow

Patient recruitment took place at the University of Pittsburgh Digestive Disorders Clinic. Start date for enrollment was November 11, 2008 - February 16, 2011

The subjects were excluded if they had a history of a heritable cancer syndrome, autoimmune disease, or a malignancy within 5 years before the enrollment, excluding nonmelanoma skins cancer.

Participant milestones

Participant milestones
Measure	MUC1 Poly-ICLC MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
Overall Study STARTED	46
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	MUC1 Poly-ICLC MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	6

Baseline Characteristics

Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MUC1 Poly-ICLC n=46 Participants MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=99 Participants
Age, Categorical >=65 years	7 Participants n=99 Participants
Sex: Female, Male Female	21 Participants n=99 Participants
Sex: Female, Male Male	25 Participants n=99 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: Of the 46 subjects who consented to participate, 6 did not receive vaccine: 4 had abnormal screening laboratory test, 1 did not meet criteria for an advanced adenoma, and 1 declined to participate

Evaluation of 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.

Outcome measures

Outcome measures
Measure	MUC1 Poly-ICLC n=39 Participants MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
Number of Participants With Anti Muc-1 Antibody	39 participants

SECONDARY outcome

Timeframe: 52 weeks

Evaluate for autoimmune response by measuring the Anti-muc-1 IgG antibodies to the muc-1 vaccine.

Outcome measures

Outcome measures
Measure	MUC1 Poly-ICLC n=39 Participants MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
Number of Participants With Autoimmune Response to Muc-1 Vaccine	39 participants

SECONDARY outcome

Timeframe: 54 weeks

Laboratory monitoring including Toxicity laboratory test or monitored through out the study up to week 54.

Outcome measures

Outcome measures
Measure	MUC1 Poly-ICLC n=39 Participants MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
Number of Participants With Adverse Events Associated With the Study Agent	39 participants

Adverse Events

MUC1 Poly-ICLC

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MUC1 Poly-ICLC n=39 participants at risk MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
Skin and subcutaneous tissue disorders injection site discomfort/ reddness	100.0% 39/39 • Number of events 39
Immune system disorders Fatigue	7.7% 3/39 • Number of events 3
General disorders Headache	7.7% 3/39 • Number of events 3

Additional Information

Robert E. Schoen ME

University Pittsburgh

Phone: 412-648-9115

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place