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

NCT02411019

Collaborator

(none)

Enrollment

Location

44.1

Anticipated Duration (Months)

1.5

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 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 Design

Study Type:

Observational

Actual Enrollment :

67 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Prospective, Observational, Open-label, Multi-center, Follow-up Clinical Study to Determine Recurrence of Cervical Intraepithelial Neoplasia and Evaluate the Long-term Safety of GX-188E, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electroporation (EP) in Subjects Who Were Diagnosed With HPV(Human Papillomavirus) 16 or 18 Positive Cervical Intraepithelial Neoplasia 3 (CIN 3) and Participated in Phase 2 Trial (GX-188E_CIN3_P2)

Actual Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Nov 1, 2018

Anticipated Study Completion Date :

Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Observational group Subjects in the period less than 24 weeks after the final administration of GX-188E	Biological: GX-188E 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. Other Names: GX-188E administered by electrophoration

Arm

Intervention/Treatment

Observational group

Subjects in the period less than 24 weeks after the final administration of GX-188E

Biological: GX-188E

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.

Other Names:

GX-188E administered by electrophoration

Outcome Measures

Primary Outcome Measures

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

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 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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Guro Hospital	Seoul		Korea, Republic of	152-703

Sponsors and Collaborators

Genexine, Inc.

Investigators

Principal Investigator: Jong-Sup Park, M.D., The Catholic University of Korea
Principal Investigator: Tae-Jin Kim, M.D., Cheil General Hospital & Women's Healthcare Center
Principal Investigator: Jae-Kwan Lee, M.D., Korea University Guro Hospital
Principal Investigator: Chi-Heum Cho, M.D., Keimyung University Dongsan Medical Center