NCT03206138UnknownNot Applicable
A Randomized, Open-label Study to Evaluate the Safety and Efficacy of GX-188E, a DNA Therapeutic Vaccine Administered Intramuscularly by Electroporation, With GX-I7 Intravaginal Application or Imiquimod Topical Application in HPV16 and/or 18 Positive Patients With CIN3.
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Seoul St. Mary's Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less in HPV 16 or 18-associated CIN3 subjects.
Study Overview
Brief Summary
This is a study to investigate the safety and efficacy of GX-188E administered IM plus local administration of GX-I7 or Imiquimod at cervix in subjects with cervical intraepithelial neoplasia (CIN) 3.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Able and willing to comply with all study procedures and voluntarily signs informed consent form.
- •Female subjects age 19-50 years.
- •HPV 16 and/or 18 positive.
- •Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area
- •Histopathologically diagnosed with Cervical Intraepithelial Neoplasia 3, CIN 3.
Exclusion Criteria
- •Pregnancy or breastfeeding
- •History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines are not excluded).
- •Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV).
- •Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study.
Arms & Interventions
GX-188E, GX-I7
Experimental
GX-188E + GX-I7
Intervention: GX-188E, GX-I7 (Biological)
GX-188E, Imiquimod
Experimental
GX-188E + Imiquimod
Intervention: GX-188E, Imiquimod (Biological)
Outcomes
Primary Outcomes
Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less in HPV 16 or 18-associated CIN3 subjects.
Time Frame: at week 20
Secondary Outcomes
- Ratio of subjects with clearance of HPV 16 or 18 and histopathological regression of cervical lesions to CIN 1 or less.(at week 20, and week 36)
- The change of cytology of uterine cervix compared to baseline.(at screening, week 12, week 20, and week 36)
- Flt-3L concentrations in blood samples.(at week 14, week 20, and week 36.)
Investigators
Jongsup Park
Professor
Seoul St. Mary's Hospital
Study Sites (1)
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