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

Genexine

Status: Unknown

Conditions: Cervical Intraepithelial Neoplasia 3

Treatments: Biological: GX-188E

Study type: Observational

Funder types: Industry

Identifiers

NCT02411019

GX-188E_CIN3_P2_FU

Details and patient eligibility

About

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.

Full 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).

Enrollment: 67 patients

Sex: Female

Ages: 19 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

67 participants in 1 patient group

Observational group

Description:

Subjects in the period less than 24 weeks after the final administration of GX-188E

Treatment:

Biological: GX-188E