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.
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
Enrollment
9
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.
Cheil General Hospital & Women's Healthcare Center
Seoul, Korea, South Korea
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-γ ELISPOT assay) using PBMC obtained at week 0 to 180 visit every 6 months.
Time frame: at week 0 to 180 every 6 months
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
Time frame: at week 0 to 180 every 6 months
Safety profile
Safety profile would be examined by vital signs, physical examination, clinical laboratory tests etc
Time frame: at week 0 to 180 every 6 months
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