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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Intraepithelial Neoplasia 3
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 152-703
    • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The subjects who have completed the DNA vaccine administration of each dosage (1 and 4 mg).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at week -18 and 130
lesion recurrence	The change of the CIN lesion (included cervical cancer) would be compared to that of the last visit in phase II study	at week -18 and 130

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of HPV infection status	The change of HPV infection status would be compared to that of the last visit in phase II study.	at week -18 and 130
The change of cytology test result	The change of cytology status would be compared to that of the last visit in phase II study.	at week -18 and 130
The change of the immune response	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).	at week -18 and 130
Flt-3L(fms-related tyrosine kinase 3 ligand) concentration (Flt-3L ELISA) using plasma.	Pharmacodynamics evaluation of GX-188E	at week -18 and 130
Survey of pregnancy and delivery	The matters relevant to the subject of pregnancy and delivery would be collected by survey to identify occurence, frequency and characteristic.	at week -18 and 130

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: March 16, 2015
• First Submitted That Met QC Criteria: April 7, 2015
• First Posted (Estimate): April 8, 2015

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Cervical Intraepithelial Neoplasia; Adult; Phase 2 follow up
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms; Carcinoma in Situ; Cervical Intraepithelial Neoplasia
• Other Study ID Numbers: GX-188E_CIN3_P2_FU