NCT02411019

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

July 12, 2017

Status Verified

July 1, 2017

Enrollment Period

3.7 years

First QC Date

March 16, 2015

Last Update Submit

July 11, 2017

Conditions

Cervical Intraepithelial Neoplasia 3

Keywords

Phase 2 follow upCervical Intraepithelial NeoplasiaAdultSafetyEfficacy

Outcome Measures

Primary Outcomes (2)

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

    long term safety assessment of GX-188E DNA vaccine of subjects participated in GX-188E\_ CIN3\_P2 clinical trial \- Safety profile would be examined by physical examination, vital signs, ECG, clinical laboratory test etc

    at week -18 and 130

  • lesion recurrence

    The change of the CIN lesion (included cervical cancer) would be compared to that of the last visit in phase II study

    at week -18 and 130

Secondary Outcomes (5)

  • The change of HPV infection status

    at week -18 and 130

  • The change of cytology test result

    at week -18 and 130

  • The change of the immune response

    at week -18 and 130

  • Flt-3L(fms-related tyrosine kinase 3 ligand) concentration (Flt-3L ELISA) using plasma.

    at week -18 and 130

  • Survey of pregnancy and delivery

    at week -18 and 130

Study Arms (1)

Observational group

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

Biological: GX-188E

Interventions

GX-188EBIOLOGICAL

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.

Also known as: GX-188E administered by electrophoration
Observational group

Eligibility Criteria

Age19 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Those who voluntarily signed informed consent form
  • The subjects who have participated in phase II trial(GX-188E\_CIN3\_P2)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and PBMC (peripheral blood mononeuclear cell)

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

GX-188 vaccine

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Jong-Sup Park, M.D.

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

  • Tae-Jin Kim, M.D.

    Cheil General Hospital & Women's Healthcare Center

    PRINCIPAL INVESTIGATOR

  • Jae-Kwan Lee, M.D.

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

  • Chi-Heum Cho, M.D.

    Keimyung University Dongsan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2015

First Posted

April 8, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

July 12, 2017

Record last verified: 2017-07

Locations

KR(1)