Safety and Efficacy of GX-188E Administered Via EP Plus GX-I7 or Imiquimod.

A Randomized, Open-label Study to Evaluate the Safety and Efficacy of GX-188E, a DNA Therapeutic Vaccine Administered Intramuscularly by Electroporation, With GX-I7 Intravaginal Application or Imiquimod Topical Application in HPV16 and/or 18 Positive Patients With CIN3.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03206138

Enrollment

Registered

2017-07-02

Start date

2017-05-30

Completion date

2018-10-31

Last updated

2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Intraepithelial Neoplasia 3

Keywords

Investigator trial, Cervical Intraepithelial Neoplasia

Brief summary

This is a study to investigate the safety and efficacy of GX-188E administered IM plus local administration of GX-I7 or Imiquimod at cervix in subjects with cervical intraepithelial neoplasia (CIN) 3.

Interventions

BIOLOGICALGX-188E, GX-I7

Experimental: 1mg of GX-188E administered IM using EP device 3 times and 3mg of GX-I7 administered in cervix 4 times.

BIOLOGICALGX-188E, Imiquimod

1mg of GX-188E administered IM using EP device 3 times and 12.5mg of Imiquimod application at cervix 8 times.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Able and willing to comply with all study procedures and voluntarily signs informed consent form. * Female subjects age 19-50 years. * HPV 16 and/or 18 positive. * Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area * Histopathologically diagnosed with Cervical Intraepithelial Neoplasia 3, CIN 3.

Exclusion criteria

* Pregnancy or breastfeeding * History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines are not excluded). * Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV). * Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study.

Design outcomes

Primary

Measure	Time frame
Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less in HPV 16 or 18-associated CIN3 subjects.	at week 20

Secondary

Measure	Time frame
Ratio of subjects with clearance of HPV 16 or 18 and histopathological regression of cervical lesions to CIN 1 or less.	at week 20, and week 36
The change of cytology of uterine cervix compared to baseline.	at screening, week 12, week 20, and week 36
Flt-3L concentrations in blood samples.	at week 14, week 20, and week 36.

Countries

South Korea

Contacts

Primary ContactJong-Sup Park

jspark@catholic.ac.kr+82-2-2258-2724

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026