MedTrace Logo

Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation

NCT02411019 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2017-07-12

No results posted yet for this study

Summary

This study is to follow up on the change of immune response by measuring HPV type 16/18 E6 and E7 specific T cell response and lesion condition in subjects who have administered in DNA-based therapeutic vaccine.

Conditions

  • Cervical Intraepithelial Neoplasia 3

Interventions

BIOLOGICAL

GX-188E

In phase II study, 72 patients were assigned to two dose groups (1mg and 4mg) and were administered three times with GX-188E by electroporation during an entire period of study. After the final administration, the follow-up will be conducted to investigate safety and efficacy aspects.

Sponsors & Collaborators

  • Genexine, Inc.

    lead INDUSTRY

Principal Investigators

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

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

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

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

Eligibility

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

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-11-30
Completion
2018-11-30

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 NCT02411019 on ClinicalTrials.gov