Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 participated GX-188E phase II trial(GX-188E_CIN3_P2).
Subjects will make visits 7 times for about three years from the last visit of GX-188E phase 2 trial (GX-188E_CIN3_P2).
The endpoints are to evaluate the change of immune response, involved lesion and infection status compared to that of the final visit in phase 2 trial (GX-188E_CIN3_P2).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational group | Subjects in the period less than 24 weeks after the final administration of GX-188E |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GX-188E | Biological | In phase II study, 72 patients were assigned to two dose groups (1mg 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 |
|---|---|---|
| Safety assessment examined by physical examination, vital signs, ECG, clinical laboratory test etc | long term safety assessment of GX-188E DNA vaccine of subjects participated in GX-188E_ CIN3_P2 clinical trial - Safety profile would be examined by physical examination, vital signs, ECG, clinical laboratory test etc | at week -18 and 130 |
| lesion recurrence | The change of the CIN lesion (included cervical cancer) would be compared to that of the last visit in phase II study | at week -18 and 130 |
| Measure | Description | Time Frame |
|---|---|---|
| The change of HPV infection status | The change of HPV infection status would be compared to that of the last visit in phase II study. | at week -18 and 130 |
| The change of cytology test result | The change of cytology status would be compared to that of the last visit in phase II study. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The subjects who have completed the DNA vaccine administration of each dosage (1 and 4 mg).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jong-Sup Park, M.D. | The Catholic University of Korea | Principal Investigator |
| Tae-Jin Kim, M.D. | Cheil General Hospital & Women's Healthcare Center | Principal Investigator |
| Jae-Kwan Lee, M.D. | Korea University Guro Hospital | Principal Investigator |
| Chi-Heum Cho, M.D. | Keimyung University Dongsan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | 152-703 | South Korea |
Not provided
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000604106 | GX-188 vaccine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
plasma and PBMC (peripheral blood mononeuclear cell)
|
|
| at week -18 and 130 |
| The change of the immune response | It would be determined by evaluating HPV type 16/18 E6 and E7 specific T cell response (IFN-γ ELISPOT: enzyme-linked immunospot assay) using PBMC(peripheral blood monocyte). | at week -18 and 130 |
| Flt-3L(fms-related tyrosine kinase 3 ligand) concentration (Flt-3L ELISA) using plasma. | Pharmacodynamics evaluation of GX-188E | at week -18 and 130 |
| Survey of pregnancy and delivery | The matters relevant to the subject of pregnancy and delivery would be collected by survey to identify occurence, frequency and characteristic. | at week -18 and 130 |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |