Trials / Completed
CompletedNCT02139267
Dose-finding, Safety Study of Plasmid DNA Therapeutic Vaccine to Treat Cervical Intraepithelial Neoplasia
A Randomized, Open-label, Multi-center, Phase 2 Clinical Trial to Determine the Optimal Dose and Evaluate 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 Cervical Intraepithelial Neoplasia 3 (CIN 3)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Genexine, Inc. · Industry
- Sex
- Female
- Age
- 19 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the optimal dose of GX-188E for the Phase 3 and access the efficacy and safety of GX-188E according the protocol in patients with Cervical Intraepithelial Neoplasia 3 (CIN3).
Detailed description
Subjects who are eligible for this study are allocated to one of the two treatment groups of GX-188E. All Subject received GX-188E intramuscularly using the electroporator(EP) on alternating deltoid muscles which will be performed totally three times during the study period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GX-188E | DNA vaccine administered via IM route using TDS-IM electroporation device |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2016-03-01
- Completion
- 2016-03-01
- First posted
- 2014-05-15
- Last updated
- 2017-07-12
Locations
4 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02139267. Inclusion in this directory is not an endorsement.