Clinical trial · Observational
Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation
A Prospective, Observational, Open-label, Multi-center, Follow-up Clinical Study to Determine Recurrence of Cervical Intraepithelial Neoplasia and Evaluate the Long-term Safety of GX-188E, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electroporation (EP) in Subjects Who Were Diagnosed With HPV(Human Papillomavirus) 16 or 18 Positive Cervical Intraepithelial Neoplasia 3 (CIN 3) and Participated in Phase 2 Trial (GX-188E_CIN3_P2)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia 3 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GX-188E | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational group
- description
- Subjects in the period less than 24 weeks after the final administration of GX-188E
- interventionNames
- Biological: GX-188E
Primary outcomes (2)
- measure
- Safety assessment examined by physical examination, vital signs, ECG, clinical laboratory test etc
- timeFrame
- at week -18 and 130
- description
- 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
- measure
- lesion recurrence
- timeFrame
- at week -18 and 130
- description
- The change of the CIN lesion (included cervical cancer) would be compared to that of the last visit in phase II study
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available