MedPath

Phase I study to follow up on the change of immunogenicity and lesion condition in subjects who have administered in DNA-based therapeutic vaccine

Not Applicable
Active, not recruiting
Conditions
Not Applicable
Registration Number
KCT0001526
Lead Sponsor
Gegexine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
Female
Target Recruitment
9
Inclusion Criteria

1) The subjects who have visited within 48 weeks after final injection of GX-188E
2) Those who voluntarily signed informed consent form

Exclusion Criteria

1)Prior participation in any clinical trial within 30 days prior to the visit 1
2) 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
NameTimeMethod
Immune response (IFN-? ELISPOT assay)
Secondary Outcome Measures
NameTimeMethod
the change of histopathological test;the change of cytological test;the change of HPV infection status;Safety profile(vital signs, physical examination, clinical laboratory tests etc.)
© Copyright 2025. All Rights Reserved by MedPath