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

Genexine, Inc.67 enrolled

Overview

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.

This is a follow-up study to investigate the change of immunogenicity and lesion condition in subjects with cervical intraepithelial neoplasia (CIN) 3 who have enrolled and participated GX-188E phase II trial(GX-188E\_CIN3\_P2). Subjects will make visits 7 times for about three years from the last visit of GX-188E phase 2 trial (GX-188E\_CIN3\_P2). The endpoints are to evaluate the change of immune response, involved lesion and infection status compared to that of the final visit in phase 2 trial (GX-188E\_CIN3\_P2).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cervical Intraepithelial Neoplasia 3

Interventions

GX-188EBIOLOGICAL

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.

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Those who voluntarily signed informed consent form * The subjects who have participated in phase II trial(GX-188E\_CIN3\_P2) Exclusion Criteria: * The subjects who didn't receive GX-188E DNA vaccine during Phase II trial (GX-188E\_CIN3\_P2) * The subjects, it is difficult to participate in this study continuously * Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study

Locations (1)

Korea University Guro Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Safety assessment examined by physical examination, vital signs, ECG, clinical laboratory test etc

long term safety assessment of GX-188E DNA vaccine of subjects participated in GX-188E\_ CIN3\_P2 clinical trial \- Safety profile would be examined by physical examination, vital signs, ECG, clinical laboratory test etc