DNA vaccine aims to clear HPV16 and reverse early cervical changes

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).