Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Plasmid DNA Therapeutic Vaccine(GX-188E)

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 2 Clinical Trial to Evaluate the Efficacy and 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 Biopsy-proven Cervical Intraepithelial Neoplasia Grade 2(CIN2), Grade 2/3 (CIN2/3), Grade 3(CIN3)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02596243
• Other study ID #: HPV-EU-001
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 3, 2015
• Last updated: July 11, 2017
• Start date: August 2015
• Est. completion date: August 2018

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 access the efficacy and safety of GX-188E according the protocol in patients with Cervical Intraepithelial Neoplasia 2, 2/3 or 3 (CIN3)

Description:

Not provided

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 134
• Est. completion date: August 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Female subjects age 18-60 years

2. Histologically confirmed HPV-16 or HPV-18 asspcoated CIN2, CIN 2/3 or CIN3 from tissue collected less than 10 weeks prior to Vaccination/EP #1 with overall lesion sizes less than 50% of the cervix area and no evidence of invasive cancer in any specimen;

3. Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area;

4. Healthy subjects as judged by the Investigator based on medical history, PE, and normal results for an ECG, CBC, Serum Chemistries, CPK and urinalysis done up to 4 weeks prior to enrolment;

5. For women who are not postmenopausal (at least 12 months of nontherapy- induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use a highly effective method of contraception during the treatment period and throughout Week 36 response evaluation visit.

6. Able and willing to comply with all study procedures and voluntarily signs informed consent form.

Exclusion Criteria:

1. Unsatisfactory colposcopy defined as incomplete visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area;

2. Pregnancy or breastfeeding;

3. Immunosuppression including any concurrent condition requiring the continued use of systemic or topical steroids at or near the injection site [deltoid, upper arm] (excluding inhaled and eye drop-containing corticosteroids) or the use of immunosuppressive agents. All other corticosteroids must be discontinued > 4 weeks prior to Day 0 of study vaccine administration; autoimmune disorders, transplant recipients;

4. History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines (e.g. Gardasil®, Cervarix®) are not excluded);

5. Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV);

6. Administration of any blood product within 3 months of enrollment;

7. Administration of any licensed vaccine within 2 weeks of enrollment (4 weeks for measles vaccine);

8. Participation in a study with an investigational compound or device within 30 days prior to signing informed consent;

9. Cardiac pre-excitation syndromes (such as Wolff-Parkinson-White);

10. History of seizures (unless seizure free for 5 years);

11. Tattoos, scars, active lesions/rashes or any implantable leads within 3 cm of the intended site of vaccination/EP;

12. Any electronic medical implants (such as cardiac pacemaker);

13. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements;

14. A tendency for severe haemorrhage following acute trauma;

15. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness must not be enrolled into this study;

16. Any other conditions judged by the investigator that would limit the evaluation of a subject.

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Neoplasms

Intervention

Biological:
• GX-188E
1mg of GX-188E administered IM using EP device at day 0, week 4 and week 12.
• Placebo
0.5mL of Placebo administered IM using EP device at day 0, week 4 and week 12.

Locations

Country	Name	City	State
Estonia	East Tallinn Central Hospital	Tallinn
Estonia	North Estonia Medical Centre Foundation	Tallinn
Estonia	Tartu University Hospital	Tartu
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	CHA Gangnam Medical Center	Seoul
Korea, Republic of	Cheil General Hospital & Women's Healthcare Center	Seoul
Korea, Republic of	Ehwa Womans University Mokdong Hospital	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Ukraine	Kharkiv medical academy of postgraduate education	Kharkiv
Ukraine	National Academy of Medical Sciences of Ukraine	Kyiv
Ukraine	Multi-profile Medical Center (University Clinic No. 1) of Odesa National	Odessa
Ukraine	State Institution Zaporizhzhia Medical Academy of Post-Graduate Education	Zaporizhzhya

Sponsors (1)

Lead Sponsor	Collaborator
Genexine, Inc.

Countries where clinical trial is conducted

Estonia,  Korea, Republic of,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with histopathological regression of cervical lesions to CIN1 or less	The number of participants with cervical lesions regress to CIN1 or less at the 36 week visit	36 weeks
Secondary	Number of participants with Clearance of HPV 16 or 18 in combination with histopathological regression of cervical lesions to CIN1 or less	The number of participants with clearance of HPV 16 or 18 in combination with histopathological regression of cervical lesions to CIN1 or less at the 36 week visit	36 weeks