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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
DNA vaccine administered via IM route using TDS-IM electroporation device
Keimyung University Dongsan Medical Center
Daegu, South Korea
Cheil General Hospital & Women's Healthcare Center
Seoul, South Korea
The Catholic University of Korea Seoul St.Mary's Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
The Rate of Participants with Histopathological Regression of Cervical Lesions to CIN1 or Less
Time frame: 20 weeks
The Rate of Participants Whose Result Inverted Negative in HPV DNA test
Time frame: 20 weeks
The rate of HPV E6, E7-specific ELISPOT responder defined in the protocol
Time frame: 20 weeks
Cytological Changes of the Cervical Lesions
Time frame: 20 weeks
The Rate of Adverse Events and the Related Features after Administration of Investigational Product
Time frame: 20 weeks
The Rate of Solicited Adverse Events and the Related Features
Time frame: 20 weeks
Data in Physical examination, Vital signs, Electrocardiography, Clinical Laboratory Test Results Related to Investigational Product
Time frame: 20 weeks
Mean Value of Visual Analogue Scale on Pain Intensity
Time frame: 20 weeks
Flt-3L Serum Concentration
Time frame: 20 weeks
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