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Safety of GX-188E DNA Therapeutic Vaccine Administered by Electroporation to Cervical Intraepithelial Neoplasia Grade 3 (CIN3)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01634503
First Posted: July 6, 2012
Last Update Posted: February 17, 2014
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.
Information provided by (Responsible Party):
Genexine, Inc.
  Purpose
This study is to determine maximum tolerable dose (MTD) of GX 188E by defining the safety profile the safety and maximum tolerated dose of GX-188E administered by electroporation in Cervical Intraepithelial Neoplasia grade 3 (CIN 3) patients.

Condition Intervention Phase
Cervical Intraepithelial Neoplasia 3 Genetic: GX-188E administered by electroporation Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center, Open-label, Dose-escalating, Phase Ι Study to Evaluate the Safety of GX-188E Administered by Electroporation (EP) in DNA-based Therapeutic Vaccine for Patients With Cervical Intraepithelial Neoplasia Grade 3 (CIN 3)

Resource links provided by NLM:


Further study details as provided by Genexine, Inc.:

Primary Outcome Measures:
  • Determination of maximum MTD by defining the safety profile of GX-188E [ Time Frame: From baseline to end of study ]
    It would be determined based on the rate and severity grade of events or abnormalities through evaluating systemic or local adverse events, clinical laboratory test results, vital signs and so on.


Secondary Outcome Measures:
  • The expression levels of GX-188E in blood [ Time Frame: At week -2, week 2, week 12 ,week 20 and week 36 ]
  • Immunologic reactogenicity by measuring HPV E6 and E7 specific T cell response (IFN-γ ELISPOT) [ Time Frame: At week -2, week 2, week 12 ,week 20 and week 36 ]
  • The changes of the involved lesions and HPV infection status [ Time Frame: Baseline, week 12 ,week 20 and week 36 ]

Enrollment: 9
Study Start Date: November 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1mg of GX-188E by electroporation Genetic: GX-188E administered by electroporation
Patients will be assigned to three dose groups:1mg, 2mg, and 4mg. Each patient will be administered GX-188E by electroporation in entire study period. The Maximum Tolerated Dose of GX-188E will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.
Other Name: Trigrid™ Delivery System
Experimental: 2mg of GX-188E by electroporation Genetic: GX-188E administered by electroporation
Patients will be assigned to three dose groups:1mg, 2mg, and 4mg. Each patient will be administered GX-188E by electroporation in entire study period. The Maximum Tolerated Dose of GX-188E will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.
Other Name: Trigrid™ Delivery System
Experimental: 4mg of GX-188E by electroporation Genetic: GX-188E administered by electroporation
Patients will be assigned to three dose groups:1mg, 2mg, and 4mg. Each patient will be administered GX-188E by electroporation in entire study period. The Maximum Tolerated Dose of GX-188E will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.
Other Name: Trigrid™ Delivery System

Detailed Description:

This study is an open-label, dose-escalation, single-center, phase I study to evaluate the safety of GX-188E, a DNA-based therapeutic vaccine, administered by electroporation (EP) in patients with HPV-16 or HPV-18 associated cervical intraepithelial neoplasia grade 3 (CIN 3).

Each subject eligible to participate in the trial is given a subject number, which is assigned sequentially in ascending order, then allocated to only a single dose level of the drug. Three subjects are allocated at each dose level starting with 1mg whereby the dose is escalated in sequential subjects in ascending numerical order of subject ID.

Each subject visit the site three times for administration during the study and is given an intramuscular injection of GX-188E at a dose of 1mg, 2mg or 4mg by electroporation at each visit

The subjects conduct the follow-up visits twice, which are 8 weeks and 24 weeks after the third injection of GX-188E respectively.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female aged between 20 and 50(inclusive).
  • Those who promised not to get pregnant from initiation to the first follow-up visit
  • Who has diagnosed with Cervical Intraepithelial Neoplasia 3 by histopathologic examination and HPV type 16 or 18 detected
  • Those who signed a voluntary written informed consent form for study participation.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Administration of immunosuppressant or immunomodulator within 6 months prior to the enrollment
  • Concomitant medication of any corticosteroid agents within 4 weeks prior to vaccination with the test drug
  • Prior immunotherapy against HPV
  • Administration of any blood products within 3 months prior to the screening visit
  • Administration of any vaccine within 4 weeks prior to the screening visit (ex. Hepatitis A vaccine, Hepatitis B vaccine, Influenza vaccine, Td etc.)
  • Positive serum test results for hepatitis C virus, hepatitis B virus surface antigen(HBsAg), or HIV
  • Prior participation in any clinical trial within 30 days prior to the screening visit
  • Patients predisposed to inflammatory reaction due to use of medical devices such as electroporation within 30 days of screening visit
  • Past history of epilepsy or convulsion within 2 years prior to the screening visit
  • 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.
  • The thickness of skin fold covering deltoid muscles, intended injection sites, >40mm
  • Any orthopedic artificial implant around the intended sites of electroporation (deltoid muscles)
  • Any history of severe adverse drug events or severe allergic diseases
  • Sinus bradycardia whose resting heart rate < 50beats/min.
  • Pre-excitation syndrome such as Wolff-Parkinson-White syndrome
  • Artificial implants or metallic implants
  • Abnormal electrocardiography (ECG) including arrhythmia
  • Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01634503


Locations
Korea, Republic of
Cheil General Hospital & Women's Healthcare Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Genexine, Inc.
Investigators
Principal Investigator: Tae Jin Kim Cheil General Hospital & Women's Healthcare Center
  More Information

Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT01634503     History of Changes
Other Study ID Numbers: GX-188E-SN
First Submitted: July 3, 2012
First Posted: July 6, 2012
Last Update Posted: February 17, 2014
Last Verified: February 2014

Keywords provided by Genexine, Inc.:
3+3 design
Phase 1
Cervical Intraepithelial Neoplasia
Adult
Safety
Dose Finding

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


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