Clinical trial NCT02596243: Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Plasmid DNA Therapeutic Vaccine(GX-188E)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Intraepithelial Neoplasia
Keywords: CIN2, CIN2/3, CIN3
Cervical Intraepithelial Neoplasia
High-Risk HPV
HPV infection
precancer Diseases
Double Blind
Safety/Efficacy
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-04
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Detailed description: Not provided

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with histopathological regression of cervical lesions to CIN1 or less
timeFrame: 36 weeks
Secondary outcomes:
measure: Number of participants with Clearance of HPV 16 or 18 in combination with histopathological regression of cervical lesions to CIN1 or less
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Cheil General Hospital & Women's Healthcare Center
city: Seoul
country: Korea, Republic of
facility: CHA Gangnam Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Ehwa Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Kharkiv
country: Ukraine
facility: Kharkiv medical academy of postgraduate education
city: Kyiv
country: Ukraine
facility: National Academy of Medical Sciences of Ukraine
city: Odessa
country: Ukraine
facility: Multi-profile Medical Center (University Clinic No. 1) of Odesa National
city: Zaporizhzhya
country: Ukraine
facility: State Institution Zaporizhzhia Medical Academy of Post-Graduate Education
Study officials:
affiliation: Tartu University Hospital
name: Terje Raud, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: North Estonia Medical Centre Foundation
name: Kersti Kukk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: East Tallinn Central Hospital
name: Aira Peri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Academy of Medical Sciences of Ukraine
name: Tetiana Tatarchuk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine
name: Nataliya Lutsenko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kharkiv medical academy of postgraduate education
name: Sergiy Kartashov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Multi-profile Medical Center (University Clinic No. 1) of Odesa National Medical University
name: Natalia Rozhkovska, MD
role: PRINCIPAL_INVESTIGATOR
References: