Clinical trial NCT02411019: 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Intraepithelial Neoplasia 3
Keywords: Phase 2 follow up
Cervical Intraepithelial Neoplasia
Adult
Safety
Efficacy
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-08
Enrollment: 67
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects who have completed the DNA vaccine administration of each dosage (1 and 4 mg).

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).

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

Primary outcomes:
measure: Safety assessment examined by physical examination, vital signs, ECG, clinical laboratory test etc
timeFrame: at week -18 and 130
measure: lesion recurrence
timeFrame: at week -18 and 130
Secondary outcomes:
measure: The change of HPV infection status
timeFrame: at week -18 and 130
measure: The change of cytology test result
timeFrame: at week -18 and 130
measure: The change of the immune response
timeFrame: at week -18 and 130
measure: Flt-3L(fms-related tyrosine kinase 3 ligand) concentration (Flt-3L ELISA) using plasma.
timeFrame: at week -18 and 130
measure: Survey of pregnancy and delivery
timeFrame: at week -18 and 130
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Jong-Sup Park, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cheil General Hospital & Women's Healthcare Center
name: Tae-Jin Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Guro Hospital
name: Jae-Kwan Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Keimyung University Dongsan Medical Center
name: Chi-Heum Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
References: