SAFETY PHARMACOLOGY STUDY OF HER1-ECD THERAPEUTIC CANCER PEPTIDE VACCINE IN A HUMANIZED MOUSE MODEL
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Hood College Biology
Biomedical and Environmental Science
Citation of Original Publication
The purpose of this study is to conduct a Safety Pharmacology evaluation of HERT-ECD vaccine in a humanized mouse model as a part of the Investigational New Drug package to be submitted to the Food and Drug Administration (FDA). The humanized mice will be created via engraftment of human peripheral blood mononuclear cells (PBMCs) into adult SNOD/Lt-scidnull mice. The Safety Pharmacology assessment will consist of evaluation of the potential to cause undesirable effects on the cardiovascular and respiratory systems and a special safety study, an in vivo cytokine release syndrome (CRS) assay. After receiving one dose of treatment or controls, respectively, the mice will be bled at nine time intervals to obtain samples for human cytokine evaluation using the MSD Th1/Th2 ELISA kit (Meso Scale Discoveries). Additionally, the mice will be placed on an ECGenie (Mouse Specifics, Inc.) electrocardiogram for cardiovascular evaluation and into a FinePointe whole-body plethysmograph (Buxco Electronics) chamber for respiratory evaluation. Statistical appraisal of treatment versus control results will include two-way ANOVA and Student's t-test.