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
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|Condition or disease||Intervention/treatment|
|Cervical Intraepithelial Neoplasia 3||Biological: GX-188E|
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|
|Actual Enrollment :||67 participants|
|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|
Subjects in the period less than 24 weeks after the final administration of 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
- 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
- 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.
Biospecimen Retention: Samples Without DNA
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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|
- Those who voluntarily signed informed consent form
- The subjects who have participated in phase II trial(GX-188E_CIN3_P2)
- 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
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
|Korea, Republic of|
|Korea University Guro Hospital|
|Seoul, Korea, Republic of, 152-703|
|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|
|Responsible Party:||Genexine, Inc.|
|Other Study ID Numbers:||
|First Posted:||April 8, 2015 Key Record Dates|
|Last Update Posted:||July 12, 2017|
|Last Verified:||July 2017|
Phase 2 follow up
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type