NCT02411019

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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 67 (actual)
• Sponsor: Genexine, Inc. · Industry
• Sex: Female
• Age: 19 Years – 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cervical Intraepithelial Neoplasia 3

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2015-04-08
• Last updated: 2017-07-12

Locations

1 site across 1 country: South Korea