Dose-finding, Safety Study of Plasmid DNA Therapeutic Vaccine to Treat Cervical Intraepithelial Neoplasia

Phase 2

Completed

• Conditions: Cervical Intraepithelial Neoplasia
• Interventions: Biological: GX-188E

• Registration Number: NCT02139267
• Lead Sponsor: Genexine, Inc.

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 Timeline

• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-15
• Study Start: 2014-07
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-11
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4mg of GX-188E per dose	GX-188E	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.
1mg of GX-188E per dose	GX-188E	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.

Primary Outcome Measures

Name	Time	Method
The Rate of Participants with Histopathological Regression of Cervical Lesions to CIN1 or Less	20 weeks

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (4)

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Cheil General Hospital & Women's Healthcare Center; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea Seoul St.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of