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

Cervical Intraepithelial Neoplasia 3 Clinical Trial

Official title:

A Single Center, Phase I Study to Follow-up on the Change of Immunogenicity and Lesion Condition in Subjects Who Have Completed the Phase I GX-188E Trial (Protocol no. GX-188E-SN)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02100085
• Other study ID #: GX-188E-FU
• Status: Active, not recruiting
• Phase: N/A
• First received: March 24, 2014
• Last updated: July 11, 2017
• Start date: February 2014
• Est. completion date: January 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• GX-188E
In phase I study, 9 patients were assigned to three dose groups (1mg, 2mg 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	Cheil General Hospital & Women's Healthcare Center	Seoul	Korea

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	The change of the immune response compared to that of the final visit in phase I study	It would be determined by evaluating HPV type 16/18 E6 and E7 specific T cell response (IFN-? ELISPOT assay) using PBMC obtained at week 0 to 180 visit every 6 months.	at week 0 to 180 every 6 months
Secondary	The change of the involved lesion and HPV infection status	The changes of histological test, cytological test and HPV infection status would be compared to that of the last visit in phase I study	at week 0 to 180 every 6 months
Secondary	Safety profile	Safety profile would be examined by vital signs, physical examination, clinical laboratory tests etc	at week 0 to 180 every 6 months