VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High Grade Squamous Intraepithelial Lesion (HSIL) in Individuals Seronegative for Human Immunodeficiency Virus (HIV)-1/2

Exclusion Criteria

• •Untreated micro invasive or invasive cancer;
• •Biopsy-proven Vaginal Intraepithelial Neoplasia (VAIN) and not undergoing medical care and/or treatment for VAIN;
• •Biopsy-proven Vulvar Intraepithelial Neoplasia (VIN) and not undergoing medical care and/or treatment for VIN;
• •Biopsy-proven Cervical Intraepithelial Neoplasia (CIN) 2/3 and not undergoing medical care and/or treatment for CIN;
• •Biopsy-proven Penile Intraepithelial Neoplasia (PIN) and not undergoing medical care and/or treatment for PIN;
• •Anal or anal/peri-anal HSIL that is not accessible for sampling by biopsy instrument;
• •Intra-anal and/or peri-anal lesion(s) that cannot be fully visualized at Screening;
• •Inability to have complete and satisfactory high resolution anoscopic exams (HRAs)
• •Any treatment for anal or anal/peri-anal HSIL (e.g. surgery) within 4 weeks of Screening;
• •Pregnant, breast feeding or considering becoming pregnant within one month following the last dose of study medication;
• •Presence of any abnormal clinical laboratory values greater than Grade 1 per Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03 within 45 days prior to Day 0 or less than Grade 1 but deemed clinically significant by the Investigator;
• •Immunosuppression as a result of underlying illness or treatment;
• •History of previous therapeutic HPV vaccination;
• •Receipt of any non-study related non-live vaccine within 2 weeks of any VGX-3100 dose;
• •Receipt of any non-study related live vaccine (e.g. measles vaccine) within 4 weeks of any VGX-3100 dose;
• •Significant acute or chronic medical illness that could be negatively impacted by the electroporation treated as deemed by the Investigator;
• •Current or history of clinically significant, medically unstable disease which, in the judgment of the investigator, would jeopardize the safety of the subject, interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results;
• •Prior major surgery within 4 weeks of Day 0;
• •Participation in an interventional study with an investigational compound or device within 4 weeks of signing the ICF;
• •Any illness or condition that in the opinion of the Investigator may affect the safety of the subject or the evaluation of any study endpoint.