UnknownNot Applicable

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

South Korea67 participantsStarted 2015-03

Plain-language summary

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.

Who can participate

Age range

19 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety assessment examined by physical examination, vital signs, ECG, clinical laboratory test etc

Timeframe: at week -18 and 130

lesion recurrence

Timeframe: at week -18 and 130

Trial details

NCT IDNCT02411019

SponsorGenexine, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-11

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