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: NCT02411019
• 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 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 Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-04-07
• Study First Posted: 2015-04-08
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-11
• Last Update Posted: 2017-07-12
• Primary Completion: 2018-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 67

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational group	GX-188E	Subjects in the period less than 24 weeks after the final administration of GX-188E

Primary Outcome Measures

Name	Time	Method
Safety assessment examined by physical examination, vital signs, ECG, clinical laboratory test etc	at week -18 and 130	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
lesion recurrence	at week -18 and 130	The change of the CIN lesion (included cervical cancer) would be compared to that of the last visit in phase II study

Secondary Outcome Measures

Name	Time	Method
The change of cytology test result	at week -18 and 130	The change of cytology status would be compared to that of the last visit in phase II study.
The change of HPV infection status	at week -18 and 130	The change of HPV infection status would be compared to that of the last visit in phase II study.
The change of the immune response	at week -18 and 130	It would be determined by evaluating HPV type 16/18 E6 and E7 specific T cell response (IFN-γ ELISPOT: enzyme-linked immunospot assay) using PBMC(peripheral blood monocyte).
Flt-3L(fms-related tyrosine kinase 3 ligand) concentration (Flt-3L ELISA) using plasma.	at week -18 and 130	Pharmacodynamics evaluation of GX-188E
Survey of pregnancy and delivery	at week -18 and 130	The matters relevant to the subject of pregnancy and delivery would be collected by survey to identify occurence, frequency and characteristic.

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of