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

Sponsor

Genexine, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02100085

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Intraepithelial Neoplasia 3	Biological: GX-188E

Detailed Description

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 completed GX-188E phase I study.

Subjects will make visits at week 48 (V1) to week 228 (V8) every 6 months after the final administration of GX-188E.

The endpoints are to evaluate the change of immune response, involved lesion and infection status compared to that of the final visit in phase I study.

Study Design

Study Type:

Observational

Actual Enrollment :

9 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Single Center, Phase I Study to Follow-up on the Change of Immunogenicity and Lesion Condition in Subjects Who Have Completed the Phase I GX-188E Trial (Protocol no. GX-188E-SN)

Actual Study Start Date :

Feb 1, 2014

Anticipated Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Observational group Subjects in the period less than 48 weeks after the final administration of GX-188E	Biological: GX-188E In phase I study, 9 patients were assigned to three dose groups (1mg, 2mg 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. Other Names: GX-188E administerd by eletrophoration

Arm

Intervention/Treatment

Observational group

Subjects in the period less than 48 weeks after the final administration of GX-188E

Biological: GX-188E

In phase I study, 9 patients were assigned to three dose groups (1mg, 2mg 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.

Other Names:

GX-188E administerd by eletrophoration

Outcome Measures

Primary Outcome Measures

The change of the immune response compared to that of the final visit in phase I study [at week 0 to 180 every 6 months]
It would be determined by evaluating HPV type 16/18 E6 and E7 specific T cell response (IFN-γ ELISPOT assay) using PBMC obtained at week 0 to 180 visit every 6 months.

Secondary Outcome Measures

The change of the involved lesion and HPV infection status [at week 0 to 180 every 6 months]
The changes of histological test, cytological test and HPV infection status would be compared to that of the last visit in phase I study
Safety profile [at week 0 to 180 every 6 months]
Safety profile would be examined by vital signs, physical examination, clinical laboratory tests etc

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female aged between 20 and 50 (inclusive)
The subjects who have visited within 48 weeks after final injection of GX-188E
Those who voluntarily signed informed consent form

Exclusion Criteria:

Prior participation in any clinical trial within 30 days prior to the visit 1
Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study