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Dose-finding, Safety Study of Plasmid DNA Therapeutic Vaccine to Treat Cervical Intraepithelial Neoplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139267
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Genexine, Inc.

Tracking Information
First Submitted Date  ICMJE May 13, 2014
First Posted Date  ICMJE May 15, 2014
Last Update Posted Date July 12, 2017
Actual Study Start Date  ICMJE July 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
The Rate of Participants with Histopathological Regression of Cervical Lesions to CIN1 or Less [ Time Frame: 20 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
  • The Rate of Participants Whose Result Inverted Negative in HPV DNA test [ Time Frame: 20 weeks ]
  • The rate of HPV E6, E7-specific ELISPOT responder defined in the protocol [ Time Frame: 20 weeks ]
  • Cytological Changes of the Cervical Lesions [ Time Frame: 20 weeks ]
  • The Rate of Adverse Events and the Related Features after Administration of Investigational Product [ Time Frame: 20 weeks ]
  • The Rate of Solicited Adverse Events and the Related Features [ Time Frame: 20 weeks ]
  • Data in Physical examination, Vital signs, Electrocardiography, Clinical Laboratory Test Results Related to Investigational Product [ Time Frame: 20 weeks ]
  • Mean Value of Visual Analogue Scale on Pain Intensity [ Time Frame: 20 weeks ]
  • Flt-3L Serum Concentration [ Time Frame: 20 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-finding, Safety Study of Plasmid DNA Therapeutic Vaccine to Treat Cervical Intraepithelial Neoplasia
Official Title  ICMJE A Randomized, Open-label, Multi-center, Phase 2 Clinical Trial to Determine the Optimal Dose and Evaluate the Safety of GX-188E, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electroporation (EP) in HPV Type 16 and/or 18 Positive Patients With Cervical Intraepithelial Neoplasia 3 (CIN 3)
Brief Summary The purpose of this study is to determine the optimal dose of GX-188E for the Phase 3 and access the efficacy and safety of GX-188E according the protocol in patients with Cervical Intraepithelial Neoplasia 3 (CIN3).
Detailed Description Subjects who are eligible for this study are allocated to one of the two treatment groups of GX-188E. All Subject received GX-188E intramuscularly using the electroporator(EP) on alternating deltoid muscles which will be performed totally three times during the study period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Intraepithelial Neoplasia
Intervention  ICMJE Biological: GX-188E
DNA vaccine administered via IM route using TDS-IM electroporation device
Other Name: DNA therapeutic vaccine
Study Arms  ICMJE
  • Experimental: 1mg of GX-188E per dose
    1mg of GX-188E per dose will be administered on 1mg group participants through intramuscular route using EP device. The injection points are at 0 week, 4 week and 12 week.
    Intervention: Biological: GX-188E
  • Experimental: 4mg of GX-188E per dose
    4mg of GX-188E per dose will be administered on 4mg group participants through intramuscular route using EP device. The injection points are at 0 week, 4 week and 12week.
    Intervention: Biological: GX-188E
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2014)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Voluntarily signed informed consent form after receiving education about this study and the investigational product.
  2. Female aged between 19 and 50 years
  3. Positive test results for HPV Type 16 and/or Type 18
  4. Histopathologically-confirmed Cervical Intraepithelial Neoplasia 3
  5. Entire cervical area including entire squamocolumnar junction is visualized through colposcopy
  6. Eligible based on screening test results.
  7. Promised not to get pregnant throughout the study

Exclusion Criteria:

  1. Suspected Adenocarcinoma in situ
  2. Malignant cancer more than Stage I
  3. Pregnancy or breastfeeding
  4. Participation in clinical trials within 30 days of the screening visit
  5. Administration of immunosuppressant or immunomodulator within 6 months prior to the enrolment
  6. Administered with systemic steroid(as a standard with Prednisolone, more than 20mg/day for every 14 days or more) within 3 months of Day 1(including ointment, eye drops, inhalated or nasal, intra-ligamental or intra-articular injection, but not applicable if injected every other day
  7. Administered any blood products within 3 months prior to the screening visit
  8. Administered any vaccine within 4 weeks prior to the screening visit(ex. Hepatitis A, Hepatitis B, Influenza, Td etc.)
  9. Positive serum test results for hepatitis C virus, hepatitis B virus surface antigen(HBsAg) or HIV
  10. Severe hepatopathy which is Class C according to Child-Pough's classification
  11. Severe renal dysfunction where the creatinine clearance(CLcr) is lower than 30ml/min
  12. CPK test results more than 2.5 times the upper limit of normal
  13. Predisposed to inflammatory reaction due to use of medical devices such as electroporation within 30 days of screening visit
  14. History of severe adverse drug events or severe allergic diseases
  15. History of epilepsy or convulsion within 2 years prior to the screening visit
  16. At the discretion of the investigator, the skin condition covering deltoid muscles, within 2cm of the intended sites of injection, is not suitable for injection due to infection, ulcer, edema, tattoo, scar, injury etc.
  17. The thickness of skin fold covering deltoid muscles, intended injection sites, > 40mm
  18. Any orthopedic artificial implant around the intended sites of electroporation (deltoid muscles)
  19. Sinus bradycardia whose resting heart rate < 50 beats/min
  20. Pre-excitation syndrome such as Wolff-Parkinson-White syndrome
  21. Abnormal electrocardiography(ECG) including arrhythmia
  22. Artificial implants or metallic implants
  23. Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02139267
Other Study ID Numbers  ICMJE GX-188E_CIN3_P2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genexine, Inc.
Study Sponsor  ICMJE Genexine, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Park Jong-Sup, M.D. The Catholic University of Korea
Principal Investigator: Kim Tae-Jin, M.D. Cheil General Hospital & Women's Healthcare Center
Principal Investigator: Lee Jae-kwan, M.D. Korea University Guro Hospital
Principal Investigator: Cho Chi-heum, M.D. Keimyung University Dongsan Medical Center
PRS Account Genexine, Inc.
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP