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

Not Applicable

Recruiting

• Conditions: Diseases of The genitoruinary system

• Registration Number: KCT0001581
• Lead Sponsor: Gegexine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

1) Those who voluntarily signed informed consent form
2) The subjects who have participated in phase II trial(GX-188E_CIN3_P2)

Exclusion Criteria

1) The subjects who didn't receive GX-188E DNA vaccine during phase II trial
2) The subject, it is difficult to participate in this study continuosly
3) Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ong term safety assessment of GX-188E DNA vaccine of subjects participated in GX-188E_CIN3_P2 clinical trial;The change of the CIN lesion (included cervical cancer) would be compared to that of the last visit in phase II study

Secondary Outcome Measures

Name	Time	Method
The change of HPV infection status;The change of cytology test result;The change of the immune response;Flt-3L(fms-related tyrosine kinase 3 ligand) concentration (Flt-3L ELISA) using plasma;Survey of pregnancy and delivery