NCT02100085

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

A Single Center, Phase I Study to Follow-up on the Change of Immunogenicity and Lesion Condition in Subjects Who Have Completed the Phase I GX-188E Trial (Protocol no. GX-188E-SN)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: Genexine, Inc. · Industry
• Sex: Female
• Age: 20 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 completed GX-188E phase I study. Subjects will make visits at week 48 (V1) to week 228 (V8) every 6 months after the final administration of GX-188E. The endpoints are to evaluate the change of immune response, involved lesion and infection status compared to that of the final visit in phase I study.

Conditions

• Cervical Intraepithelial Neoplasia 3

Interventions

Type	Name	Description
BIOLOGICAL	GX-188E	In phase I study, 9 patients were assigned to three dose groups (1mg, 2mg 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: 2014-02-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2014-03-31
• Last updated: 2017-07-12

Locations

1 site across 1 country: South Korea