Cervical Intraepithelial Neoplasia 3
Conditions
Keywords
Phase 2 follow up, Cervical Intraepithelial Neoplasia, Adult, Safety, Efficacy
Brief 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.
Detailed 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 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).
Interventions
BIOLOGICALGX-188E
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.
Sponsors
Genexine, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Those who voluntarily signed informed consent form * The subjects who have participated in phase II trial(GX-188E\_CIN3\_P2)
Exclusion criteria
* The subjects who didn't receive GX-188E DNA vaccine during Phase II trial (GX-188E\_CIN3\_P2) * The subjects, it is difficult to participate in this study continuously * Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessment examined by physical examination, vital signs, ECG, clinical laboratory test etc | at week -18 and 130 | 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 |
| lesion recurrence | at week -18 and 130 | The change of the CIN lesion (included cervical cancer) would be compared to that of the last visit in phase II study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of the immune response | at week -18 and 130 | 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). |
| The change of HPV infection status | at week -18 and 130 | The change of HPV infection status would be compared to that of the last visit in phase II study. |
| Survey of pregnancy and delivery | at week -18 and 130 | The matters relevant to the subject of pregnancy and delivery would be collected by survey to identify occurence, frequency and characteristic. |
| Flt-3L(fms-related tyrosine kinase 3 ligand) concentration (Flt-3L ELISA) using plasma. | at week -18 and 130 | Pharmacodynamics evaluation of GX-188E |
| The change of cytology test result | at week -18 and 130 | The change of cytology status would be compared to that of the last visit in phase II study. |
Countries
South Korea
Outcome results
None listed