Phase I Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Immunogenicity of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation (EP) in Adult Females Post Surgical or Ablative Treatment of Grade 2 or 3 Cervical Intraepithelial Neoplasia (CIN)
Inclusion Criteria:
- Written informed consent in accordance with institutional guidelines;
- Female 18-45 years of age;
- 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 D);
- Normal ECG and normal laboratory values as judged by Grade 0-1 as per Toxicity
Grading Scale for Healthy Adults (Appendix C) for CBC, CPK, SMA-12 and urinalysis
evaluations done up to 30 days prior to administration of study treatment;
- Body mass index (BMI) ≤30 kg/m2;
- 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 3 months
after the last injection (~6 months);
- Able and willing to comply with all study procedures.
Exclusion Criteria:
- Active infection with herpes simplex virus (HSV);
- Positive serological test for HIV virus, hepatitis C virus or Hepatitis B virus
surface antigen (HBsAg);
- Pregnant or breastfeeding subjects;
- 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;;
- Administration of any blood product within 3 months of enrollment;
- Administration of any vaccine within 6 weeks of enrollment;
- Patient is currently participating or has participated in a study with an
investigational compound or device within 30 days of signing informed consent;
- Metal implants at the site of injection;
- Active drug or alcohol use or dependence that, in the opinion of the investigator,
would interfere with adherence to study requirements;
- 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;
- Any other conditions judged by the investigator that would limit the evaluation of a
subject.