Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01304524 | A Study of VGX-3100 DNA Vaccine With Electroporation in Patients With Cervical Intraepithelial Neoplasia Grade 2/3 or 3 | PHASE2 | COMPLETED | 167 | — | — | Apr 1, 2011 | Apr 1, 2015 | Sep 7, 2018 | 43 | United States, Australia +7 |
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.
| Arm | Type | Description |
|---|---|---|
| VGX 3100 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| VGX 3100 | BIOLOGICAL | 1ml of VGX-3100 delivered IM followed by electroporation at Day 0, Week 4 and Week 12. |
| Placebo | BIOLOGICAL | 1ml of placebo delivered IM followed by electroporation at Day 0, Week 4 and Week 12. |
| CELLECTRA™-5P | DEVICE | CELLECTRA™-5P is used for electroporation following IM delivery of VGX 3100 or placebo on Day 0, Week 4 and Week 12. |
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...