Mammaglobin-A DNA Vaccine for Metastatic Breast Cancer

Phase 1

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Biological: Mammaglobin-A DNA vaccine

• Registration Number: NCT00807781
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this study is to evaluate the safety of mammaglobin-A DNA vaccine in metastatic breast cancer patients.

Detailed Description

This is a phase I open-label study to evaluate the safety and immunogenicity of a plasmid mammaglobin-A DNA vaccine. The plasmid mammaglobin-A DNA vaccine will be formulated as a naked plasmid DNA vaccine (WUSM-MGBA-01). The hypothesis of this study is that the mammaglobin-A DNA vaccine will be safe for human administration and capable of generating measurable CD8 T cell responses to mammaglobin-A. The primary objective of this study is to demonstrate the safety of the mammaglobin-A DNA vaccine. The secondary objective is to evaluate the immunogenicity of the mammaglobin-A DNA vaccine as measured by ELISPOT analysis, a surrogate for CD8 T cell function.

Study Timeline

• Study First Submitted: 2008-12-11
• Study First Submitted QC: 2008-12-11
• Study First Posted: 2008-12-12
• Study Start: 2009-10
• Primary Completion: 2014-03
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-02
• Last Update Posted: 2015-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mammaglobin-A DNA vaccine	Mammaglobin-A DNA vaccine	Patients will receive vaccine day 1 (week 1), week 4 (day 29 +/- 7), week 8 (day 57 +/- 7) with at least 21 days between injection days. All injections will be given intramuscularly using a jet delivery device. Patients will be administered the vaccine in lateral shoulder and buttocks positions that will be rotated with each administration in the above order.

Primary Outcome Measures

Name	Time	Method
Evaluate safety of mammaglobin-A DNA vaccine, WUSM-MGBA-01	30 days after completion of treatment

Secondary Outcome Measures

Name	Time	Method
To evaluate the immunogenicity of the mammaglobin-A DNA vaccine, WUSTL-MGBA-01. Immunogenicity will be measured by ELISPOT analysis, a surrogate for CD8 T cell function.	52 weeks

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States