Accession Number : ADA593925


Title :   Rapid Translation of a Novel and Potent Vaccine in HER2+ Metastatic Breast Cancer Patients


Descriptive Note : Final rept. 15 Sep 2006-14 Sep 2013


Corporate Author : DUKE UNIV DURHAM NC


Personal Author(s) : Lyerly, H K


Full Text : https://apps.dtic.mil/dtic/tr/fulltext/u2/a593925.pdf


Report Date : Oct 2013


Pagination or Media Count : 143


Abstract : 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 I/II study to evaluate the combination of the two vectors with the primary endpoint being clinical benefit.


Descriptors :   *BREAST CANCER , *METASTASIS , *VACCINES , ANTIBODIES , CLINICAL MEDICINE , DISEASE VECTORS , IMMUNITY , IMMUNOTHERAPY , PATIENTS , POTENCY , RELEASE , RESPONSE(BIOLOGY) , T LYMPHOCYTES , VIRUSES


Subject Categories : Medicine and Medical Research


Distribution Statement : APPROVED FOR PUBLIC RELEASE