Trial Outcomes & Findings for Vaccination of High Risk Breast Cancer Patients (NCT NCT01390064)

Last Updated: 2019-08-20

Results Overview

The safety and tolerability of the P10s-PADRE/MONTANIDE ISA51 VG vaccine will be determined by toxicity assessments throughout the duration of the study. Subjects will be evaluated for toxicity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

6 participants

Primary outcome timeframe

9 weeks per subject

Results posted on

2019-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Initial Cohort Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule	Escalation Cohort Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule
Overall Study STARTED	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Initial Cohort n=3 Participants Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule	Escalation Cohort n=3 Participants Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule	Total n=6 Participants Total of all reporting groups
Age, Continuous	57.0 years STANDARD_DEVIATION 17.4 • n=3 Participants	56.0 years STANDARD_DEVIATION 9.5 • n=3 Participants	56.5 years STANDARD_DEVIATION 12.6 • n=6 Participants
Sex: Female, Male Female	3 Participants n=3 Participants	3 Participants n=3 Participants	6 Participants n=6 Participants
Sex: Female, Male Male	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	3 participants n=3 Participants	3 participants n=3 Participants	6 participants n=6 Participants
Performance Status (ECOG)	0.0 ECOG units on a scale 0 Best-5 Worst STANDARD_DEVIATION 0.0 • n=3 Participants	0.3 ECOG units on a scale 0 Best-5 Worst STANDARD_DEVIATION 0.6 • n=3 Participants	0.2 ECOG units on a scale 0 Best-5 Worst STANDARD_DEVIATION 0.4 • n=6 Participants
Lines of Prior Endocrine Therapy	0.7 Numbers of therapy STANDARD_DEVIATION 1.2 • n=3 Participants	1.7 Numbers of therapy STANDARD_DEVIATION 1.5 • n=3 Participants	1.2 Numbers of therapy STANDARD_DEVIATION 1.3 • n=6 Participants
Lines of Prior Chemotherapy	1.3 Numbers of therapy STANDARD_DEVIATION 0.6 • n=3 Participants	1.3 Numbers of therapy STANDARD_DEVIATION 0.6 • n=3 Participants	1.3 Numbers of therapy STANDARD_DEVIATION 0.5 • n=6 Participants

PRIMARY outcome

Timeframe: 9 weeks per subject

Outcome measures

Outcome measures
Measure	Initial Cohort n=3 Participants Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule	Escalation Cohort n=3 Participants Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule
Number of Participants With a Dose-limiting Toxicity (Defined as an Adverse Event of Grade 3 or Higher)	0 participants	0 participants

Adverse Events

Initial Cohort

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Escalation Cohort

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Laura Hutchins

University of Arkansas for Medical Sciences

Phone: 5016868274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Initial Cohort n=3 participants at risk Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule	Escalation Cohort n=3 participants at risk Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule
Nervous system disorders Peripheral sensory neuropathy	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Immune system disorders Autoimmune disorder: Increase in ANA	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Skin and subcutaneous tissue disorders Skin Induration	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Skin and subcutaneous tissue disorders Rash maculopapular	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Nervous system disorders Paresthesia	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
General disorders Other: tender knots at the site of injections	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Gastrointestinal disorders Colonic hemorrhage	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Blood and lymphatic system disorders Anemia	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Skin and subcutaneous tissue disorders Skin induration: small lumps on abdomen at site of study drug administration	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Skin and subcutaneous tissue disorders Other: Subcutaneous nodule at injection site	66.7% 2/3 • Number of events 2 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Respiratory, thoracic and mediastinal disorders Sinus disorder	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Skin and subcutaneous tissue disorders Skin induration: abdomen and right upper arm	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Skin and subcutaneous tissue disorders Pain of skin: constant soreness at injection sites when the area is touched	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Injury, poisoning and procedural complications Other	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Skin and subcutaneous tissue disorders Other: bitten by unknown insect on the back of left leg	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Infections and infestations Sinusitis	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.
Cardiac disorders Palpitations	0.00% 0/3 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.	33.3% 1/3 • Number of events 1 • 7 months during and after the vaccine was administered. All-cause Mortality AEs and Serious Adverse Events were monitored but there are none to report. All Other(Not Including Serious) Adverse Events have been provided in a table format.