Dose-finding, Safety Study of Plasmid DNA Therapeutic Vaccine to Treat Cervical Intraepithelial Neoplasia
A Randomized, Open-label, Multi-center, Phase 2 Clinical Trial to Determine the Optimal Dose and Evaluate the Safety of GX-188E, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electroporation (EP) in HPV Type 16 and/or 18 Positive Patients With Cervical Intraepithelial Neoplasia 3 (CIN 3)
1 other identifier
interventional
72
1 country
4
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2014
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2014
CompletedFirst Posted
Study publicly available on registry
May 15, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJuly 12, 2017
July 1, 2017
1.7 years
May 13, 2014
July 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Rate of Participants with Histopathological Regression of Cervical Lesions to CIN1 or Less
20 weeks
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (2)
1mg of GX-188E per dose
EXPERIMENTAL1mg 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.
4mg of GX-188E per dose
EXPERIMENTAL4mg 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.
Interventions
DNA vaccine administered via IM route using TDS-IM electroporation device
Eligibility Criteria
You may qualify if:
- 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
- Histopathologically-confirmed Cervical Intraepithelial Neoplasia 3
- 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
You may not qualify if:
- Suspected Adenocarcinoma in situ
- Malignant cancer more than Stage I
- Pregnancy or breastfeeding
- Participation in clinical trials within 30 days of the screening visit
- Administration of immunosuppressant or immunomodulator within 6 months prior to the enrolment
- 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
- Administered any vaccine within 4 weeks prior to the screening visit(ex. Hepatitis A, Hepatitis B, Influenza, Td etc.)
- Positive serum test results for hepatitis C virus, hepatitis B virus surface antigen(HBsAg) or HIV
- Severe hepatopathy which is Class C according to Child-Pough's classification
- Severe renal dysfunction where the creatinine clearance(CLcr) is lower than 30ml/min
- CPK test results more than 2.5 times the upper limit of normal
- Predisposed to inflammatory reaction due to use of medical devices such as electroporation within 30 days of screening visit
- History of severe adverse drug events or severe allergic diseases
- History of epilepsy or convulsion within 2 years prior to the screening visit
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genexine, Inc.lead
Study Sites (4)
Keimyung University Dongsan Medical Center
Daegu, 700-712, South Korea
Cheil General Hospital & Women's Healthcare Center
Seoul, 100-380, South Korea
The Catholic University of Korea Seoul St.Mary's Hospital
Seoul, 137-701, South Korea
Korea University Guro Hospital
Seoul, 152-703, South Korea
Related Publications (1)
Cho HW, Jeong S, Song SH, Kim YT, Kim JW, Cho CH, Hur SY, Chang SJ, Kim YM, Lee JK. A phase 1/2a, dose-escalation, safety, and preliminary efficacy study of the RKP00156 vaginal tablet in healthy women and patients with cervical intraepithelial neoplasia 2. J Gynecol Oncol. 2024 Jul;35(4):e52. doi: 10.3802/jgo.2024.35.e52. Epub 2024 Jan 24.
PMID: 38330377DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2014
First Posted
May 15, 2014
Study Start
July 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
July 12, 2017
Record last verified: 2017-07