Brief Title
Dose-finding, Safety Study of Plasmid DNA Therapeutic Vaccine to Treat Cervical Intraepithelial Neoplasia
Official Title
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)
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).
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
The Rate of Participants with Histopathological Regression of Cervical Lesions to CIN1 or Less
Secondary Outcome
The Rate of Participants Whose Result Inverted Negative in HPV DNA test
Condition
Cervical Intraepithelial Neoplasia
Intervention
GX-188E
Study Arms / Comparison Groups
1mg of GX-188E per dose
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
72
Start Date
July 2014
Completion Date
March 2016
Primary Completion Date
March 2016
Eligibility Criteria
Inclusion Criteria:
1. Voluntarily signed informed consent form after receiving education about this study
and the investigational product.
2. Female aged between 19 and 50 years
3. Positive test results for HPV Type 16 and/or Type 18
4. Histopathologically-confirmed Cervical Intraepithelial Neoplasia 3
5. Entire cervical area including entire squamocolumnar junction is visualized through
colposcopy
6. Eligible based on screening test results.
7. Promised not to get pregnant throughout the study
Exclusion Criteria:
1. Suspected Adenocarcinoma in situ
2. Malignant cancer more than Stage I
3. Pregnancy or breastfeeding
4. Participation in clinical trials within 30 days of the screening visit
5. Administration of immunosuppressant or immunomodulator within 6 months prior to the
enrolment
6. 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
7. Administered any blood products within 3 months prior to the screening visit
8. Administered any vaccine within 4 weeks prior to the screening visit(ex. Hepatitis A,
Hepatitis B, Influenza, Td etc.)
9. Positive serum test results for hepatitis C virus, hepatitis B virus surface
antigen(HBsAg) or HIV
10. Severe hepatopathy which is Class C according to Child-Pough's classification
11. Severe renal dysfunction where the creatinine clearance(CLcr) is lower than 30ml/min
12. CPK test results more than 2.5 times the upper limit of normal
13. Predisposed to inflammatory reaction due to use of medical devices such as
electroporation within 30 days of screening visit
14. History of severe adverse drug events or severe allergic diseases
15. History of epilepsy or convulsion within 2 years prior to the screening visit
16. 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.
17. The thickness of skin fold covering deltoid muscles, intended injection sites, > 40mm
18. Any orthopedic artificial implant around the intended sites of electroporation
(deltoid muscles)
19. Sinus bradycardia whose resting heart rate < 50 beats/min
20. Pre-excitation syndrome such as Wolff-Parkinson-White syndrome
21. Abnormal electrocardiography(ECG) including arrhythmia
22. Artificial implants or metallic implants
23. Any other ineligible condition at the discretion of the investigator that would be
ineligible to participate the study
Gender
Female
Ages
19 Years - 50 Years
Accepts Healthy Volunteers
No
Contacts
Park Jong-Sup, M.D., ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT02139267
Organization ID
GX-188E_CIN3_P2
Responsible Party
Sponsor
Study Sponsor
Genexine, Inc.
Study Sponsor
Park Jong-Sup, M.D., Principal Investigator, The Catholic University of Korea
Verification Date
July 2017