REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

Exclusion Criteria

• •Microscopic or gross evidence of adenocarcinoma-in-situ (AIS), high grade vulvar, vaginal, or anal intraepithelial neoplasia or invasive cancer in any histopathologic specimen at screening
• •Cervical lesion(s) that cannot be fully visualized on colposcopy
• •History of endocervical curettage (ECC) which showed cervical HSIL indeterminate, or insufficient for diagnosis
• •Treatment for cervical HSIL within 4 weeks prior to screening
• •Pregnant, breastfeeding or considering becoming pregnant during the study
• •History of previous therapeutic HPV vaccination
• •Immunosuppression as a result of underlying illness or treatment
• •Receipt of any non-study, non-live vaccine within 2 weeks of Day 0
• •Receipt of any non-study, live vaccine within 4 weeks of Day 0
• •Current or history of clinically significant, medically unstable disease or condition which, in the judgment of the investigator, would jeopardize the safety of the participant, interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results
• •Presence of acute or chronic bleeding or clotting disorder that would contraindicate IM injections, or use of blood thinners within 2 weeks of Day 0
• •Participation in an interventional study with an investigational compound or device within 30 days of signing informed consent
• •Less than two acceptable sites available for IM injection