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Trial record 1 of 1 for:    02139267
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Dose-finding, Safety Study of Plasmid DNA Therapeutic Vaccine to Treat Cervical Intraepithelial Neoplasia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genexine, Inc.
ClinicalTrials.gov Identifier:
NCT02139267
First received: May 13, 2014
Last updated: May 13, 2016
Last verified: May 2016
  Purpose
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).

Condition Intervention Phase
Cervical Intraepithelial Neoplasia
Biological: GX-188E
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Genexine, Inc.:

Primary Outcome Measures:
  • The Rate of Participants with Histopathological Regression of Cervical Lesions to CIN1 or Less [ Time Frame: 20 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 72
Study Start Date: May 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: GX-188E
DNA vaccine administered via IM route using TDS-IM electroporation device
Other Name: DNA therapeutic vaccine
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.
Biological: GX-188E
DNA vaccine administered via IM route using TDS-IM electroporation device
Other Name: DNA therapeutic vaccine

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.
  Eligibility

Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02139267

Locations
Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of, 700-712
Cheil General Hospital & Women's Healthcare Center
Seoul, Korea, Republic of, 100-380
The Catholic University of Korea Seoul St.Mary's Hospital
Seoul, Korea, Republic of, 137-701
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703
Sponsors and Collaborators
Genexine, Inc.
Investigators
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
  More Information

Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT02139267     History of Changes
Other Study ID Numbers: GX-188E_CIN3_P2
Study First Received: May 13, 2014
Last Updated: May 13, 2016

Keywords provided by Genexine, Inc.:
CIN3
Cervical Intraepithelial Neoplasia
High-Risk HPV
HPV Infection
Neoplasm
Precancerous Diseases
Uterine Diseases
Genital Diseases, Female

Additional relevant MeSH terms:
Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017