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.
Full Title of Study: “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.”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: October 2018
- Biological: GX-188E, GX-I7
- Experimental: 1mg of GX-188E administered IM using EP device 3 times and 3mg of GX-I7 administered in cervix 4 times.
- Biological: GX-188E, Imiquimod
- 1mg of GX-188E administered IM using EP device 3 times and 12.5mg of Imiquimod application at cervix 8 times.
Arms, Groups and Cohorts
- Experimental: GX-188E, GX-I7
- GX-188E + GX-I7
- Experimental: GX-188E, Imiquimod
- GX-188E + Imiquimod
Clinical Trial Outcome Measures
- 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
- Ratio of subjects with clearance of HPV 16 or 18 and histopathological regression of cervical lesions to CIN 1 or less.
- Time Frame: at week 20, and week 36
- The change of cytology of uterine cervix compared to baseline.
- Time Frame: at screening, week 12, week 20, and week 36
- Flt-3L concentrations in blood samples.
- Time Frame: at week 14, week 20, and week 36.
Participating in This Clinical Trial
- 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.
Gender Eligibility: Female
Minimum Age: 19 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Seoul St. Mary’s Hospital
- Genexine, Inc.
- Provider of Information About this Clinical Study
- Principal Investigator: Jongsup Park, Professor – Seoul St. Mary’s Hospital
- Overall Contact(s)
- Jong-Sup Park, +82-2-2258-2724, firstname.lastname@example.org
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