Rapid Translation of a Novel and Potent Vaccine in HER2+ Metastatic Breast Cancer Patients
Final rept. 15 Sep 2006-14 Sep 2013
DUKE UNIV DURHAM NC
Pagination or Media Count:
This clinical translation research award proposed to evaluate a novel viral vector vaccine combination for testing in Trastuzumab-refractory breast cancer patients. Both viral vectors express the human HER2 gene and individually promote potent immune responses mediated by cellular and antibody-mediated immunity. One is an adenovirus construct Ad-HER2 and the other is an alphavirus VRP construct VRP-HER2. We have demonstrated that both vectors elicit potent T cell and antibody responses and that these antibody responses are capable of both inhibiting the proliferation and directly killing Traztuzumab-refractory human breast cancer cells. The grant involves the manufacturing, safety testing, toxicology, and lot release testing, and submission of IND applications for the two vectors. Phase I safety studies were planned to evaluate primarily the safety of each vector in first in human studies. Our long term goal is to initiate a phase III study to evaluate the combination of the two vectors with the primary endpoint being clinical benefit.
- Medicine and Medical Research