Phase II placebo-controlled study of VGX-3100, (HPV16 E6/E7, HPV18 E6/E7) DNA vaccine delivered IM followed by electroporation (EP) with Cellectra(R)-5P for the treatment of biopsy-proven CIN2/3 or CIN3 with documented HPV 16 or 18
Cornelia (Connie) Trimble
The objective of this study is to determine whether treating patients with HPV-16 or -18 associated CIN 2/3 or CIN 3 with VGX-3100 will cause regression of cervical lesions.
Healthy adult women age 18-50 years with HPV-16 or HPV-18 associated CIN2/3.
Eligible subjects will get vaccinated with VGX-3100 or placebo three times at weeks 0, 4, and 12, before having a cone or LEEP procedure at week 36. Subjects will have 12 visits over a period of 88 weeks. There are study specific blood tests and samples, as well as cervical swabs collected before and after vaccination, and at the time of surgery.
06/19/2013 04:02 AM