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Uterine Cervical Dysplasia

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Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

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Vaccines

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.

GX-188E

Jong-Sup Park, M.D.

Tae-Jin Kim, M.D.

Jae-Kwan Lee, M.D.

Chi-Heum Cho, M.D.

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.

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).

plasma and PBMC (peripheral blood mononeuclear cell)

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

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)

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

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 would be compared to that of the last visit in phase II study.

The change of cytology status would be compared to that of the last visit in phase II study.

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).

The matters relevant to the subject of pregnancy and delivery would be collected by survey to identify occurence, frequency and characteristic.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation	NCT02411019	Cervical Intrae...	GX-188E	19 Years - 50 Years	Genexine, Inc.
Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation	NCT02411019	Cervical Intrae...	GX-188E	19 Years - 50 Years	Genexine, Inc.

Spots Global Cancer Trial Database for phase 2 follow up