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

Brief Title

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

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)

Brief Summary

      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.
    

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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Determination of maximum MTD by defining the safety profile of GX-188E

Secondary Outcome

 The expression levels of GX-188E in blood

Condition

Cervical Intraepithelial Neoplasia 3

Intervention

GX-188E administered by electroporation

Study Arms / Comparison Groups

 1mg of GX-188E by electroporation

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Genetic

Estimated Enrollment

9

Start Date

November 2012

Completion Date

February 2014

Primary Completion Date

February 2014

Eligibility 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
      

Gender

Female

Ages

20 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

Tae Jin Kim, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

NCT ID

NCT01634503

Organization ID

GX-188E-SN

Responsible Party

Sponsor

Study Sponsor

Genexine, Inc.

Study Sponsor

Tae Jin Kim, Principal Investigator, Cheil General Hospital & Women's Healthcare Center

Verification Date

February 2014