PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia
The purpose of this Phase 2 study is to compare the effects of administering the PVX4 combination device biologic product (pBI-4 DNA vaccine via electroporation-mediated intramuscular delivery with the TriGrid™ Delivery System) in patients with biopsy-confirmed, human papilloma virus (HPV) 16-associated high grade cervical intraepithelial neoplasia (CIN2/3) as compared to the administration of placebo.
• Female subjects 18-60 years old with biopsy-confirmed high grade cervical intraepithelial neoplasia (CIN2/3) confirmed by central review.
• Patients whose cytobrush samples are HPV16+ by Roche Cobas genotyping test. Co-infections with HPV types other than HPV16 are permissible for study entry
• HIV negative
• Patients who are able and willing to comply with all study procedures, and with anticipated availability for the planned follow-up period of one year
• Patients who are of childbearing potential agree to remain sexually abstinent, use methods of contraception (e.g. oral contraception, barrier methods, spermicide, intrauterine device (IUD)), or have a partner who is sterile (i.e., vasectomy) through 6 months.
• Patients must have adequate organ function at the time of enrollment as defined by the following parameters: white blood cell count \>3,000/mcL; lymphocyte number \>500/mcL; absolute neutrophil count \>1,000/mcL; platelets \>90,000/mcL; hemoglobin \>9 g/dL; total bilirubin \<3 X the institutional limit of normal; aspartate aminotransferase (AST \[SGOT\]) / alanine aminotransferase (ALT \[SGPT\]) \<3 X the institutional limit of normal; creatinine \<2.5X the institutional limit of normal.