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

Cervical Intraepithelial Neoplasia 3 Clinical Trial

— GX-188E  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02411019
• Other study ID #: GX-188E_CIN3_P2_FU
• Status: Active, not recruiting
• Phase: N/A
• First received: March 16, 2015
• Last updated: July 11, 2017
• Start date: March 2015
• Est. completion date: November 2018

Study information

• Verified date: July 2017
• Source: Genexine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 67
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Cervical Intraepithelial Neoplasia 3
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Genexine, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	The change of the immune response	It would be determined by evaluating HPV type 16/18 E6 and E7 specific T cell response (IFN-? ELISPOT: enzyme-linked immunospot assay) using PBMC(peripheral blood monocyte).	at week -18 and 130
Secondary	Flt-3L(fms-related tyrosine kinase 3 ligand) concentration (Flt-3L ELISA) using plasma.	Pharmacodynamics evaluation of GX-188E	at week -18 and 130
Secondary	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