A randomized, Double-Blind, Placebo-Controlled phase II trial of pBI-4 plasmid administered via intramuscular TriGrid™ electroporation delivery system for treatment of women with HPV16-Positive grade 1 cervical intraepithelial neoplasia or persistent HPV16 infection

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with CIN1 on biopsy and whose cytologic sample is HPV16+ by Roche Cobas test in the past 30 days, OR patients with CIN\<1 on biopsy whose cytologic sample is HPV16+ by Roche Cobas test in the past 30 days and a history of a second HPV16+ test at least 6 months prior * (Co-infections with HPV types other than HPV16 are permissible for study entry) * Age ≥ 19 years * Baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of study treatment administration * Adequate organ function at the time of enrollment as defined by: White blood cell count \> 3,000/mcL Absolute lymphocyte number \> 500/mcL Absolute neutrophil count \> 1,000/mcL Platelets \> 90,000/mcL Hemoglobin \> 9 g/dL Total bilirubin \< 3 x institutional limit of normal AST(SGOT)/ALT(SGPT) \< 3 x institutional limit of normal Creatinine \< 2.5 x institutional limit of normal Women of child-bearing potential must agree to use effective contraception (hormonal and/or barrier) prior to study entry and for the duration of the study * Ability to understand and willingness to sign a written informed consent document * Subject is able to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: * Patients with AIS (adenocarcinoma in situ) or cancer determined by cervical cytology at study entry * Histologic evidence of CIN2 or above * Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive medications such as steroids * Prior treatment with any HPV therapeutic agent (e.g., Imiquimod, Veregen, Podophylotoxin) * Patients who are receiving any other investigational agents or blood products within 30 days prior to the first dose * Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance * Patients with a history of autoimmune disease such as multiple sclerosis (exclusive of a history of thyroiditis, psoriasis, Sjogren's, or inflammatory bowel disease) * Patients with a history of allergic reactions attributed to compounds used in agent preparation * Patients who are pregnant or breast feeding * Patients with active or chronic infection of HIV, HCV, or HBV * Patients who have had a prior LEEP or cervical conization procedure * History of prior malignancy (permitted only if the patient has been disease-free for ≥ 5 years, or has completely resected basal cell or squamous cell carcinoma of the skin) * Less than 1 acceptable potential injection site for intramuscular injection and electroporation (considering the left/right medial deltoid, and anterolateral quadriceps muscles) * A site is unacceptable if there is inadequate muscle mass to support at least a 19 mm (0.75 inch) injection depth or a skinfold thickness of ≥ 50 mm * (Note: For participants weighing ≤ 65 kg, acceptable sites are confined to the outer aspect of the upper thigh, and the deltoids are not eligible) * Contraindication to intramuscular injections and blood draws * A metal implant or implantable device within the area of the electroporation injection site at \> 2 of the eligible injection sites .A nonremovable electronic stimulation device (such as cardiac demand pacemakers, automatic implantable cardiac defibrillators, nerve stimulators, or deep brain stimulators).