Dose-finding, Safety Study of Plasmid DNA Therapeutic Vaccine to Treat Cervical Intraepithelial Neoplasia
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- The Rate of Participants with Histopathological Regression of Cervical Lesions to CIN1 or Less [20 weeks]
Secondary Outcome Measures
- The Rate of Participants Whose Result Inverted Negative in HPV DNA test [20 weeks]
- The rate of HPV E6, E7-specific ELISPOT responder defined in the protocol [20 weeks]
- Cytological Changes of the Cervical Lesions [20 weeks]
- The Rate of Adverse Events and the Related Features after Administration of Investigational Product [20 weeks]
- The Rate of Solicited Adverse Events and the Related Features [20 weeks]
- Data in Physical examination, Vital signs, Electrocardiography, Clinical Laboratory Test Results Related to Investigational Product [20 weeks]
- Mean Value of Visual Analogue Scale on Pain Intensity [20 weeks]
- Flt-3L Serum Concentration [20 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Voluntarily signed informed consent form after receiving education about this study and the investigational product.
-
Female aged between 19 and 50 years
-
Positive test results for HPV Type 16 and/or Type 18
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Histopathologically-confirmed Cervical Intraepithelial Neoplasia 3
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Entire cervical area including entire squamocolumnar junction is visualized through colposcopy
-
Eligible based on screening test results.
-
Promised not to get pregnant throughout the study
Exclusion Criteria:
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Suspected Adenocarcinoma in situ
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Malignant cancer more than Stage I
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Pregnancy or breastfeeding
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Participation in clinical trials within 30 days of the screening visit
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Administration of immunosuppressant or immunomodulator within 6 months prior to the enrolment
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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
-
Administered any blood products within 3 months prior to the screening visit
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Administered any vaccine within 4 weeks prior to the screening visit(ex. Hepatitis A, Hepatitis B, Influenza, Td etc.)
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Positive serum test results for hepatitis C virus, hepatitis B virus surface antigen(HBsAg) or HIV
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Severe hepatopathy which is Class C according to Child-Pough's classification
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Severe renal dysfunction where the creatinine clearance(CLcr) is lower than 30ml/min
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CPK test results more than 2.5 times the upper limit of normal
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Predisposed to inflammatory reaction due to use of medical devices such as electroporation within 30 days of screening visit
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History of severe adverse drug events or severe allergic diseases
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History of epilepsy or convulsion within 2 years prior to the screening visit
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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.
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The thickness of skin fold covering deltoid muscles, intended injection sites, > 40mm
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Any orthopedic artificial implant around the intended sites of electroporation (deltoid muscles)
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Sinus bradycardia whose resting heart rate < 50 beats/min
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Pre-excitation syndrome such as Wolff-Parkinson-White syndrome
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Abnormal electrocardiography(ECG) including arrhythmia
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Artificial implants or metallic implants
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Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Keimyung University Dongsan Medical Center | Daegu | Korea, Republic of | 700-712 | |
| 2 | Cheil General Hospital & Women's Healthcare Center | Seoul | Korea, Republic of | 100-380 | |
| 3 | The Catholic University of Korea Seoul St.Mary's Hospital | Seoul | Korea, Republic of | 137-701 | |
| 4 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GX-188E_CIN3_P2