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

July 11, 2017 updated by: Genexine, Inc.

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Korea
      • Seoul, Korea, Korea, Republic of
        • Cheil General Hospital & Women's Healthcare Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The subjects who have completed the DNA vaccine administration of each dosage (1, 2 and 4 mg).

The subjects in the period less than 48 weeks after the final administration of GX-188E

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational group
Subjects in the period less than 48 weeks after the final administration of GX-188E
Biological: 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.
Other Names:
  • GX-188E administerd by eletrophoration

What is the study measuring?

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
Time Frame: at week 0 to 180 every 6 months
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
Time Frame: at week 0 to 180 every 6 months
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
Time Frame: at week 0 to 180 every 6 months
Safety profile would be examined by vital signs, physical examination, clinical laboratory tests etc
at week 0 to 180 every 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genexine, Inc.

Investigators

  • Principal Investigator: Tae Jin Kim, M.D., Cheil General Hospital & Women's Healthcare Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

March 27, 2014

First Posted (Estimate)

March 31, 2014

Study Record Updates

Last Update Posted (Actual)

July 12, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GX-188E-FU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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