Overview

This trial is active, not recruiting.

Condition cervical intraepithelial neoplasia 3
Treatment gx-188e
Sponsor Genexine, Inc.
Start date February 2014
End date August 2017
Trial size 9 participants
Trial identifier NCT02100085, GX-188E-FU

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Subjects in the period less than 48 weeks after the final administration of GX-188E
gx-188e GX-188E administerd by eletrophoration
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.

Primary Outcomes

Measure
The change of the immune response compared to that of the final visit in phase I study
time frame: at week 0 to 180 every 6 months

Secondary Outcomes

Measure
The change of the involved lesion and HPV infection status
time frame: at week 0 to 180 every 6 months
Safety profile
time frame: at week 0 to 180 every 6 months

Eligibility Criteria

Female participants from 20 years up to 50 years old.

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

Additional Information

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)
Principal investigator Tae Jin Kim, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Genexine, Inc..