A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Mammaglobin-A DNA Vaccine in Breast Cancer Patients With Metastatic Disease

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.