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

Primary Purpose

Cervical Intraepithelial Neoplasia 3

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

GX-188E administered by electroporation

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia 3 focused on measuring 3+3 design, Phase 1, Cervical Intraepithelial Neoplasia, Adult, Safety, Dose Finding

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Cheil General Hospital & Women's Healthcare Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

1mg of GX-188E by electroporation

2mg of GX-188E by electroporation

4mg of GX-188E by electroporation

Arm Description

Outcomes

Primary Outcome Measures

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

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

Immunologic reactogenicity by measuring HPV E6 and E7 specific T cell response (IFN-γ ELISPOT)

The changes of the involved lesions and HPV infection status

Full Information

NCT ID

NCT01634503

First Posted

July 3, 2012

Last Updated

February 14, 2014

Sponsor

Genexine, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01634503

Brief Title

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

Acronym

CIN3

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genexine, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Intraepithelial Neoplasia 3

Keywords

3+3 design, Phase 1, Cervical Intraepithelial Neoplasia, Adult, Safety, Dose Finding

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1mg of GX-188E by electroporation

Arm Type

Experimental

Arm Title

2mg of GX-188E by electroporation

Arm Type

Experimental

Arm Title

4mg of GX-188E by electroporation

Arm Type

Experimental

Intervention Type

Genetic

Intervention Name(s)

GX-188E administered by electroporation

Other Intervention Name(s)

Trigrid™ Delivery System

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

From baseline to end of study

Secondary Outcome Measure Information:

Title

The expression levels of GX-188E in blood

Time Frame

At week -2, week 2, week 12 ,week 20 and week 36

Title

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

Title

The changes of the involved lesions and HPV infection status

Time Frame

Baseline, week 12 ,week 20 and week 36

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tae Jin Kim

Organizational Affiliation

Cheil General Hospital & Women's Healthcare Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cheil General Hospital & Women's Healthcare Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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