Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Cervical Intraepithelial Neoplasia 3

Intervention / Treatment
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* Biological: GX-188E


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational group<br>Subjects in the period less than 48 weeks after the final administration of GX-188E | Biological: GX-188E<br>* 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.<br>* Other names: GX-188E administerd by eletrophoration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Safety profile would be examined by vital signs, physical examination, clinical laboratory tests etc | at week 0 to 180 every 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1 follow up, Cervical Intraepithelial Neoplasia, Adult, Safety, Efficacy