Spots Global Cancer Trial Database for Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation

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Trial Identification

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

Official Title: 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)

Study ID: NCT02100085

Conditions

Cervical Intraepithelial Neoplasia 3

Interventions

GX-188E

Study Description

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 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.