Sponsors

Lead Sponsor

Inovio Pharmaceuticals

Age

18 - 46 years

Sex

FEMALE

Healthy Volunteers

No

Inclusion Criteria

•1. Written informed consent in accordance with institutional guidelines;
•2. Successful enrollment in and completion of all study procedures and follow-up in study HPV-001.
•3. Female 18-46 years of age;
•4. Post surgical (including LEEP and conization) or ablative treatment and a diagnosis of CIN 2 or 3, while under physician care as per ASCCP guidelines (Appendix C);
•5. Normal ECG and CPK, as judged by Grade 0-1 as per Toxicity Grading Scale for Healthy Adults (Appendix B) done up to 30 days prior to administration of study treatment;
•6. Body mass index (BMI) ≤30 kg/m2;
•7. Women of child-bearing potential (WOCBP) agree to remain sexually abstinent, use medically effective contraception (oral contraception, barrier methods, spermicide, etc), or have a partner who is sterile (i.e., vasectomy) from enrollment to study discharge;
•8. Able and willing to comply with all study procedures.

Exclusion Criteria

•1. Active infection with herpes simplex virus (HSV);
•2. Pregnant or breast feeding subjects;
•3. Any concurrent condition requiring the continued use of systemic or topical steroids (excluding inhaled and eye drop-containing corticosteroids) or the use of immunosuppressive agents. All other corticosteroids must be discontinued \> 4 weeks prior to Day 1 of treatment;
•4. Administration of any blood product within 3 months of enrollment;
•5. Administration of any vaccine within 6 weeks of enrollment;
•6. Patient is currently participating or has participated in a study with an investigational compound or device other than VGX-3100 within 30 days of signing informed consent;
•7. Metal implants at the site of injection;
•8. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements;
•9. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness must not be enrolled into this study;
•10. Any other conditions judged by the investigator that would limit the evaluation of a subject.

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What this study is about

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Sponsors

Related studies

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