A Phase 1 Study/DNA-Based Vaccine vs Prostatic Acid Pase

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DESCRIPTION (provided by applicant): Dr. McNeel will develop a career in patient-oriented translational research with an emphasis on the immunological treatment of patients with prostate cancer. The goal of this proposal is describe both a career training and mentoring plan through which he will receive training in the proper conduct of human subjects research, as well as a translational research plan leading to the conduct of a human vaccine trial for patients with prostate cancer. As part of his career development plan, Dr. McNeel will complete the UW Clinical Investigator Preparatory Pathway (CIPP). This program is an individualized program proviiding didactic and mentored training in the areas of biostatistics and clinical study design, clinical research ethics, leadership and management skills, presentation and teaching skills, scientific writing skills, and expertise within a specific research domain. In addition, he will be mentored directly by Dr. Mark Albertini, a leader in the field of DNA vaccien clinical trials research. His academic and career progress will be followed quarterly by the CIPP Executive Committee as well as Dr. McNeel's faculty mentoring committee at the University of Wisconsin (composed of Drs. Albertini, Sondel, Bryan and Bailey). The other part of this proposal describes a 5-year translational research plan in which Dr. McNeel proposes three aims: 1) to identify the immunological mediators of prostate tissue destruction in a rat model fo inflammatory prostatistics; 2) to identify proteins immunologically recognized in patients with chronic inflammatory prostatis; and 3) to determine in a human clinical vaccine trial the safety and immunological efficacy of a DNA-based vaccine in patients with advanced stage prostate cancer. This clinical trial will target the same antigen, prostatic acid phosphatase, and using the same DNA immunization techniques used to elicit prostatis in the rodent model. This trial will serve as a platform and model for clinical trial evaluation of antigens identified in the second aim of the proposal.