Clinical trial · Observational
Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation
A Single Center, Phase I Study to Follow-up on the Change of Immunogenicity and Lesion Condition in Subjects Who Have Completed the Phase I GX-188E Trial (Protocol no. GX-188E-SN)
NCT02100085CI-TRIAL-00028572unknownClinicalTrials.gov clinicaltrialsProvenance
- 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 48 weeks after the final administration of GX-188E
- interventionNames
- Biological: GX-188E
Primary outcomes (1)
- measure
- The change of the immune response compared to that of the final visit in phase I study
- timeFrame
- at week 0 to 180 every 6 months
- description
- 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.
Secondary outcomes (2)
- measure
- The change of the involved lesion and HPV infection status
- timeFrame
- at week 0 to 180 every 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Female aged between 20 and 50 (inclusive) * The subjects who have visited within 48 weeks after final injection of GX-188E * Those who voluntarily signed informed consent form Exclusion Criteria: * Prior participation in any clinical trial within 30 days prior to the visit 1 * 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
No reference posted for this study.