Trials / Completed
CompletedNCT01304524
A Study of VGX-3100 DNA Vaccine With Electroporation in Patients With Cervical Intraepithelial Neoplasia Grade 2/3 or 3
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.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 167 (actual)
- Sponsor
- Inovio Pharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2014-05-01
- Completion
- 2015-04-01
- First posted
- 2011-02-25
- Last updated
- 2018-09-07
Locations
43 sites across 9 countries: United States, Australia, Canada, Estonia, Georgia, India, Puerto Rico, South Africa, South Korea
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01304524. Inclusion in this directory is not an endorsement.