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

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2018-01-31

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 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.

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 48 weeks after the final administration of GX-188E

GX-188E

Intervention Type BIOLOGICAL

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.

Interventions

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GX-188E

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.

Intervention Type BIOLOGICAL

Other Intervention Names

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GX-188E administerd by eletrophoration

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No