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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-11-30

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.

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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 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).

Conditions

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Cervical Intraepithelial Neoplasia 3

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational group

Subjects in the period less than 24 weeks after the final administration of GX-188E

GX-188E

Intervention Type 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.

Interventions

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GX-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.

Intervention Type BIOLOGICAL

Other Intervention Names

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GX-188E administered by electrophoration

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No