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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: May 2014
- 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
- 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.
- 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
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 55 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Inovio Pharmaceuticals
- Provider of Information About this Clinical Study
- 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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