Trials / Unknown
UnknownNCT02596243
Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Plasmid DNA Therapeutic Vaccine(GX-188E)
A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 2 Clinical Trial to Evaluate the Efficacy and the Safety of GX-188E, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electroporation(EP) in HPV Type 16 and/or 18 Positive Patients With Biopsy-proven Cervical Intraepithelial Neoplasia Grade 2(CIN2), Grade 2/3 (CIN2/3), Grade 3(CIN3)
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 134 (actual)
- Sponsor
- Genexine, Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to access the efficacy and safety of GX-188E according the protocol in patients with Cervical Intraepithelial Neoplasia 2, 2/3 or 3 (CIN3)
Detailed description
Not provided
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GX-188E | 1mg of GX-188E administered IM using EP device at day 0, week 4 and week 12. |
| BIOLOGICAL | Placebo | 0.5mL of Placebo administered IM using EP device at day 0, week 4 and week 12. |
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2018-03-01
- Completion
- 2018-08-01
- First posted
- 2015-11-04
- Last updated
- 2017-07-12
Locations
16 sites across 3 countries: Estonia, South Korea, Ukraine
Source: ClinicalTrials.gov record NCT02596243. Inclusion in this directory is not an endorsement.