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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational group | Subjects in the period less than 48 weeks after the final administration of GX-188E |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GX-188E | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at week 0 to 180 every 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Safety profile |
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Inclusion Criteria:
Exclusion Criteria:
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The subjects who have completed the DNA vaccine administration of each dosage (1, 2 and 4 mg).
The subjects in the period less than 48 weeks after the final administration of GX-188E
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| Name | Affiliation | Role |
|---|---|---|
| Tae Jin Kim, M.D. | Cheil General Hospital & Women's Healthcare Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cheil General Hospital & Women's Healthcare Center | Seoul | Korea | South Korea |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| ID | Term |
|---|---|
| C000604106 | GX-188 vaccine |
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plasma and PBMC (peripheral blood mononeuclear cells)
|
|
Safety profile would be examined by vital signs, physical examination, clinical laboratory tests etc
| at week 0 to 180 every 6 months |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |