A Study of VGX-3100 DNA Vaccine With Electroporation in Patients With Cervical Intraepithelial Neoplasia Grade 2/3 or 3 (HPV-003)
|ClinicalTrials.gov Identifier: NCT01304524|
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : September 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cervical Intraepithelial Neoplasia||Biological: VGX 3100 Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||167 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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 Start Date :||April 2011|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||October 2015|
|Experimental: VGX 3100||
Biological: VGX 3100
1ml of VGX-3100 delivered IM followed by electroporation at Day 0, Week 4 and Week 12.
|Placebo Comparator: Placebo||
1ml of placebo delivered IM followed by electroporation at Day 0, week 4 and week 12.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304524
Show 43 Study Locations
|Principal Investigator:||Cornelia Trimble, MD||Johns Hopkins University|
|Principal Investigator:||Robert L Parker, Jr., MD||Lyndhurst Gynecologic Associates|
|Principal Investigator:||Guillermo Valenzuela, MD||Arrowhead Regional Medical Center|