Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation
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|ClinicalTrials.gov Identifier: NCT02100085|
Recruitment Status : Unknown
Verified July 2017 by Genexine, Inc..
Recruitment status was: Active, not recruiting
First Posted : March 31, 2014
Last Update Posted : July 12, 2017
|Condition or disease||Intervention/treatment|
|Cervical Intraepithelial Neoplasia 3||Biological: GX-188E|
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.
|Study Type :||Observational|
|Actual Enrollment :||9 participants|
|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)|
|Actual Study Start Date :||February 2014|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2018|
Subjects in the period less than 48 weeks after the final administration of 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.
Other Name: GX-188E administerd by eletrophoration
- 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 ]It would be determined by evaluating HPV type 16/18 E6 and E7 specific T cell response (IFN-γ ELISPOT assay) using PBMC obtained at week 0 to 180 visit every 6 months.
- The change of the involved lesion and HPV infection status [ Time Frame: at week 0 to 180 every 6 months ]The changes of histological test, cytological test and HPV infection status would be compared to that of the last visit in phase I study
- Safety profile [ Time Frame: at week 0 to 180 every 6 months ]Safety profile would be examined by vital signs, physical examination, clinical laboratory tests etc
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100085
|Korea, Republic of|
|Cheil General Hospital & Women's Healthcare Center|
|Seoul, Korea, Korea, Republic of|
|Principal Investigator:||Tae Jin Kim, M.D.||Cheil General Hospital & Women's Healthcare Center|