Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 7 for:    GX-188E
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02411019
Recruitment Status : Unknown
Verified July 2017 by Genexine, Inc..
Recruitment status was:  Active, not recruiting
First Posted : April 8, 2015
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Genexine, Inc.

Tracking Information
First Submitted Date March 16, 2015
First Posted Date April 8, 2015
Last Update Posted Date July 12, 2017
Actual Study Start Date March 2015
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 7, 2015)
  • Safety assessment examined by physical examination, vital signs, ECG, clinical laboratory test etc [ Time Frame: at week -18 and 130 ]
    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
  • lesion recurrence [ Time Frame: at week -18 and 130 ]
    The change of the CIN lesion (included cervical cancer) would be compared to that of the last visit in phase II study
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 7, 2015)
  • The change of HPV infection status [ Time Frame: at week -18 and 130 ]
    The change of HPV infection status would be compared to that of the last visit in phase II study.
  • The change of cytology test result [ Time Frame: at week -18 and 130 ]
    The change of cytology status would be compared to that of the last visit in phase II study.
  • The change of the immune response [ Time Frame: at week -18 and 130 ]
    It would be determined by evaluating HPV type 16/18 E6 and E7 specific T cell response (IFN-γ ELISPOT: enzyme-linked immunospot assay) using PBMC(peripheral blood monocyte).
  • Flt-3L(fms-related tyrosine kinase 3 ligand) concentration (Flt-3L ELISA) using plasma. [ Time Frame: at week -18 and 130 ]
    Pharmacodynamics evaluation of GX-188E
  • Survey of pregnancy and delivery [ Time Frame: at week -18 and 130 ]
    The matters relevant to the subject of pregnancy and delivery would be collected by survey to identify occurence, frequency and characteristic.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation
Official Title A Prospective, Observational, Open-label, Multi-center, Follow-up Clinical Study to Determine Recurrence of Cervical Intraepithelial Neoplasia and Evaluate the Long-term Safety of GX-188E, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electroporation (EP) in Subjects Who Were Diagnosed With HPV(Human Papillomavirus) 16 or 18 Positive Cervical Intraepithelial Neoplasia 3 (CIN 3) and Participated in Phase 2 Trial (GX-188E_CIN3_P2)
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.
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 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).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
plasma and PBMC (peripheral blood mononeuclear cell)
Sampling Method Non-Probability Sample
Study Population The subjects who have completed the DNA vaccine administration of each dosage (1 and 4 mg).
Condition Cervical Intraepithelial Neoplasia 3
Intervention Biological: 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.
Other Name: GX-188E administered by electrophoration
Study Groups/Cohorts Observational group
Subjects in the period less than 24 weeks after the final administration of GX-188E
Intervention: Biological: GX-188E
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: July 11, 2017)
67
Original Estimated Enrollment
 (submitted: April 7, 2015)
72
Estimated Study Completion Date November 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 19 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02411019
Other Study ID Numbers GX-188E_CIN3_P2_FU
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Genexine, Inc.
Study Sponsor Genexine, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: 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
PRS Account Genexine, Inc.
Verification Date July 2017