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

Cervical Intraepithelial Neoplasia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139267
• Other study ID #: GX-188E_CIN3_P2
• Status: Completed
• Phase: Phase 2
• First received: May 13, 2014
• Last updated: July 11, 2017
• Start date: July 2014
• Est. completion date: March 2016

Study information

• Verified date: July 2017
• Source: Genexine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Neoplasms

Intervention

Biological:
• GX-188E
DNA vaccine administered via IM route using TDS-IM electroporation device

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Cheil General Hospital & Women's Healthcare Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St.Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Genexine, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Rate of Participants with Histopathological Regression of Cervical Lesions to CIN1 or Less		20 weeks
Secondary	The Rate of Participants Whose Result Inverted Negative in HPV DNA test		20 weeks
Secondary	The rate of HPV E6, E7-specific ELISPOT responder defined in the protocol		20 weeks
Secondary	Cytological Changes of the Cervical Lesions		20 weeks
Secondary	The Rate of Adverse Events and the Related Features after Administration of Investigational Product		20 weeks
Secondary	The Rate of Solicited Adverse Events and the Related Features		20 weeks
Secondary	Data in Physical examination, Vital signs, Electrocardiography, Clinical Laboratory Test Results Related to Investigational Product		20 weeks
Secondary	Mean Value of Visual Analogue Scale on Pain Intensity		20 weeks
Secondary	Flt-3L Serum Concentration		20 weeks