A phase ? study to evaluate the safety of GX-188E administered by electroporation in DNA-based therapeutic vaccine for patients with Cervical Intraepithelial Neoplasia grade 3 (CIN 3)
- Conditions
- Not Applicable
- Registration Number
- KCT0000586
- Lead Sponsor
- Gegexine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 9
1)Female aged between 20 and 50 years
2)Those who promised not to get pregnant from the participation to the study until the first F/U visit (VF1)
3)Histologically confirmed HPV-16 or HPV-18 associated Cervical Intraepithelial Neoplasia grade 3 (CIN 3)
4)Those who voluntarily signed informed consent form
1)Pregnant or lactating women
2)Administration of immunosuppressant or immunomodulator within 6 months prior to the enrollment
3)Concomitant medication of any corticosteroid agents within 4 weeks prior to vaccination with the test drug (Day 0)
4)Prior immunotherapy against HPV
5)Administration of any blood products within 3 months prior to the screening visit
6)Administration of any vaccine within 4 weeks prior to the screening visit (ex. Hepatitis A vaccine, Hepatitis B vaccine, Influenza vaccine, Td etc.)
7)Positive serum test results for hepatitis C virus, hepatitis B virus surface antigen(HBsAg), or HIV
8)Prior participation in any clinical trial within 30 days prior to the screening visit
9)Patients predisposed to inflammatory reaction due to use of medical devices such as electroporation within 30 days of screening visit
10)Past history of epilepsy or convulsion within 2 years prior to the screening visit
11)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.
12)The thickness of skin fold covering deltoid muscles, intended injection sites, >40mm
13)Any orthopedic artificial implant around the intended sites of electroporation (deltoid muscles)
14)Any history of severe adverse drug events or severe allergic diseases
15)Sinus bradycardia whose resting heart rate < 50beats/min.
16)Pre-excitation syndrome such as Wolff-Parkinson-White syndrome
17)Artificial implants or metallic implants
18)Abnormal electrocardiography (ECG) including arrhythmia
19)Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety profile(vital signs, physical examination, adverse events, clinical laboratory tests etc.)
- Secondary Outcome Measures
Name Time Method the expression levels of GX-188E in blood;Immune Response (IFN-? ELISPOT assay);the changes of the involved lesions and HPV infection status