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

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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.

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.

Condition or disease Intervention/treatment
Cervical Intraepithelial Neoplasia 3 Biological: GX-188E

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).


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Study Type : Observational
Actual Enrollment : 67 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : March 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Observational group
Subjects in the period less than 24 weeks after the final administration of GX-188E
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




Primary Outcome Measures :
  1. 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


  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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

  5. 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.


Biospecimen Retention:   Samples Without DNA
plasma and PBMC (peripheral blood mononeuclear cell)


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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subjects who have completed the DNA vaccine administration of each dosage (1 and 4 mg).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411019


Locations
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Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703
Sponsors and Collaborators
Genexine, Inc.
Investigators
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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

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Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT02411019     History of Changes
Other Study ID Numbers: GX-188E_CIN3_P2_FU
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017
Keywords provided by Genexine, Inc.:
Phase 2 follow up
Cervical Intraepithelial Neoplasia
Adult
Safety
Efficacy
Additional relevant MeSH terms:
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Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Vaccines
Immunologic Factors
Physiological Effects of Drugs