pBI-11 Versus Placebo via Electroporation for the Treatment of Patients with HPV16/18+ < CIN2

Inclusion Criteria

• Patients must have: * NEIL, ASC-US, or LSIL determined by cervical cytology AND * HPV16 and/or 18+ by Roche Cobas 4800, Roche Linear Array HPV Genotyping test, or other Food and Drug Administration (FDA)-approved HPV genotyping test (Co-infections with HPV types other than HPV16/18 are permissible)
• Age ≥ 18 years
• Baseline Eastern Cooperative Oncology Group performance status of 0 or 1 at the time of enrollment
• White blood cell count ≥ 3,000 cells/uL (within 56 days of the first dose of study vaccine)
• Absolute lymphocyte number ≥ 500 cells/uL (within 56 days of the first dose of study vaccine)
• Absolute neutrophil count ≥ 1,500 cells/uL (within 56 days of the first dose of study vaccine)
• Platelets ≥ 90,000 cells/uL (within 56 days of the first dose of study vaccine)
• Hemoglobulin ≥ 9 g/dL (within 56 days of the first dose of study vaccine)
• Total bilirubin < 3 X the institutional limit of normal (within 56 days of the first dose of study vaccine)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) < 3 X the institutional limit of normal (within 56 days of the first dose of study vaccine)
• Creatinine < 2.5 X the institutional limit of normal (within 56 days of the first dose of study vaccine)
• Women of child-bearing potential must agree to use long acting contraception (e.g. tubal ligation, intrauterine device or hormonal implant) or two forms of contraception (e.g. barrier method, oral contraceptives) prior to study entry and for 3 months after final vaccination. * Women of childbearing potential are defined as any female who has experienced menarche and does not meet the criteria for “women not of childbearing potential” defined below. * Women not of childbearing potential are defined as follows: ** Women who are permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) ** Women who have experienced total cessation of menses for at least 1 year (not including cessation of menses due to pregnancy or long-term birth control) OR who have a previous clinical follicle stimulating hormone (FSH) value > 40 mIU/mL
• Ability to understand and the willingness to sign a written informed consent document
• Subject is able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria

• Histologic evidence of CIN2, CIN3, adenocarcinoma in situ or malignancy
• Patients with a diagnosis of immunosuppression or active systemic use of immunosuppressive medications such as steroids
• Patients who are receiving any other investigational agents within 28 days prior to the first dose of study vaccine
• 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 with study requirements
• Patients with a history of systemic autoimmune disease such as multiple sclerosis or systemic lupus erythematosus, but exclusive of a history of thyroiditis, psoriasis, Sjogren’s, or inflammatory bowel disease
• Patients who are pregnant or breast feeding or plan to become pregnant within 12 months of first study treatment
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to pBI-11 DNA vaccine
• Patient with active infection of, or receiving treatment for HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV)
• History of prior malignancy with disease free interval < 5 years; however, individuals with completely resected basal cell or squamous cell carcinoma of the skin within this interval may be enrolled
• Participants with metal implant(s) at the site of injection or any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators
• Participants with any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child or episode of seizure in pregnancy due to eclampsia
• Participants with syncopal episode within 12 months of screening, excluding fainting for a known and unrelated cause such as anemia which has been resolved
• Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
• Participants with a skin-fold measurement of the cutaneous and subcutaneous tissue for all eligible injection sites (vastus lateralis muscles with intact lymph drainage) exceeds 50 mm
• Participants in whom the ability to observe possible local reactions at the injection site (lateralis region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art