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

NCT02100085

GX-188E-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 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.

Enrollment: 9 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female aged between 20 and 50 (inclusive)
• The subjects who have visited within 48 weeks after final injection of GX-188E
• Those who voluntarily signed informed consent form

Exclusion criteria

• Prior participation in any clinical trial within 30 days prior to the visit 1
• Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study

Trial design

9 participants in 1 patient group

Observational group

Description:

Subjects in the period less than 48 weeks after the final administration of GX-188E

Treatment:

Biological: GX-188E