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

• Conditions: Cervical Intraepithelial Neoplasia 3
• Interventions: Biological: GX-188E

• Registration Number: NCT02100085
• Lead Sponsor: Genexine, Inc.

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.

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 Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-03-31
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-11
• Last Update Posted: 2017-07-12
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 9

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational group	GX-188E	Subjects in the period less than 48 weeks after the final administration of GX-188E

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Cheil General Hospital & Women's Healthcare Center; 🇰🇷 Seoul, Korea, Korea, Republic of