A Study of VGX-3100 DNA Vaccine With Electroporation in Patients With Cervical Intraepithelial Neoplasia Grade 2/3 or 3

Overview

This is randomized, placebo controlled study to determine safety and efficacy of VGX-3100 DNA Vaccine delivered by Electroporation to adult women with biopsy-proven HPV 16 or 18 associated Cervical intraepithelial neoplasia grade 2/3 or 3.

Full Title of Study: “Phase II Placebo Controlled Study of VGX-3100, (HPV16 E6/E7, HPV18 E6/E7 DNA Vaccine) Delivered IM Followed by Electroporation With CELLECTRA-5P for the Treatment of Biopsy-proven CIN 2/3 or CIN 3 With Documented HPV 16 or 18.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2014

Interventions

  • Biological: VGX 3100
    • 1ml of VGX-3100 delivered IM followed by electroporation at Day 0, Week 4 and Week 12.
  • Biological: Placebo
    • 1ml of placebo delivered IM followed by electroporation at Day 0, Week 4 and Week 12.
  • Device: CELLECTRA™-5P
    • CELLECTRA™-5P is used for electroporation following IM delivery of VGX 3100 or placebo on Day 0, Week 4 and Week 12.

Arms, Groups and Cohorts

  • Experimental: VGX 3100
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants with Histopathological Regression of Cervical Lesions to CIN 1 or Less as a Measure of Efficacy.
    • Time Frame: 36 weeks
    • The number of participants with histopathologically confirmed CIN2/3 or CIN 3 associated with HPV16 or HPV18 whose cervical lesions regress to CIN 1 or less at the 36 week visit.

Secondary Measures

  • Number of Participants with Virologically-proven Clearance of HPV 16 or 18 in Combination with Histopathological Regression of Cervical Lesions to CIN 1 or Less as a Secondary Measure of Efficacy
    • Time Frame: 36 Weeks
    • The number of participants with histopathologically confirmed CIN2/3 or CIN 3 associated with HPV16 or HPV18 whose cervical lesions regress to CIN 1 or less and have virologically-proven clearance of HPV16 or HPV18 at the 36 week visit.

Participating in This Clinical Trial

Inclusion Criteria

  • Female subjects age 18-55 years; – Histologically confirmed HPV-16 or HPV-18-associated CIN 2/3 or CIN 3 from tissue collected less than 10 weeks prior to Vaccination/EP #1 with no evidence of invasive cancer in any specimen; – Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area; lesions in ≤ 3 cervical quadrants (4 quadrant disease where the lesion occupies less than 50% of each quadrant will be considered for inclusion); – Healthy subjects as judged by the Investigator based on medical history, PE, and normal results for an ECG, CBC, Serum Chemistries, CPK and urinalysis done up to 4 weeks prior to enrollment and administration of study drug; – Women of child-bearing potential agree to remain sexually abstinent, use two medically effective methods of contraception (e.g. oral contraception, barrier methods, spermicide, intrauterine device (IUD)), or have a partner who is sterile (i.e., vasectomy) through 36 weeks (9 months); – Able and willing to comply with all study procedures and voluntarily signs informed consent form Exclusion Criteria:
  • Unsatisfactory colposcopy defined as incomplete visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area; – Pregnancy or breastfeeding – Immunosuppression including any concurrent condition requiring the continued use of systemic or topical steroids at or near the injection site [deltoid, upper arm] (excluding inhaled and eye drop-containing corticosteroids) or the use of immunosuppressive agents. All other corticosteroids must be discontinued > 4 weeks prior to Day 0 of study vaccine administration; autoimmune disorders, transplant recipients; – History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines (e.g. Gardasil®, Cervarix®) are not excluded); – Positive serological test for hepatitis C virus or hepatitis B virus surface antigen(HBsAg) or human immunodeficiency virus (HIV) – Administration of any blood product within 3 months of enrollment – Administration of any licensed vaccine within 2 weeks of enrollment( 4weeks for measles vaccine) – Participation in a study with an investigational compound or device within 30 days of signing informed consent; – Cardiac pre-excitation syndromes (such as Wolff-Parkinson-White); – History of seizures (unless seizure free for 5 years); – Tattoos, scars, or active lesions/rashes within 2 cm of the intended site of vaccination/EP or any implantable leads; or any implantable leads; – 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
  • Gender Eligibility: Female

    Minimum Age: 18 Years

    Maximum Age: 55 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Inovio Pharmaceuticals
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Cornelia Trimble, MD, Principal Investigator, Johns Hopkins University
      • Robert L Parker, Jr., MD, Principal Investigator, Lyndhurst Gynecologic Associates

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