MedTrace Logo

Dose-finding, Safety Study of Plasmid DNA Therapeutic Vaccine to Treat Cervical Intraepithelial Neoplasia

NCT02139267 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-07-12

No results posted yet for this study

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).

Conditions

  • Cervical Intraepithelial Neoplasia

Interventions

BIOLOGICAL

GX-188E

DNA vaccine administered via IM route using TDS-IM electroporation device

Sponsors & Collaborators

  • Genexine, Inc.

    lead INDUSTRY

Principal Investigators

  • Park Jong-Sup, M.D. · The Catholic University of Korea

  • Kim Tae-Jin, M.D. · Cheil General Hospital & Women's Healthcare Center

  • Lee Jae-kwan, M.D. · Korea University Guro Hospital

  • Cho Chi-heum, M.D. · Keimyung University Dongsan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02139267 on ClinicalTrials.gov