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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02596243
Recruitment Status : Unknown
Verified July 2017 by Genexine, Inc..
Recruitment status was:  Active, not recruiting
First Posted : November 4, 2015
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Genexine, Inc.

Study Description
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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)

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Biological: GX-188E Biological: Placebo Phase 2

Detailed Description:
Not provided
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: GX-188E
GX-188E + EP
 Biological: GX-188E
1mg of GX-188E administered IM using EP device at day 0, week 4 and week 12.
Other Name: DNA therapeutic vaccine
Placebo Comparator: placebo
Placebo + EP
 Biological: Placebo
0.5mL of Placebo administered IM using EP device at day 0, week 4 and week 12.
Other Name: Placebo-control


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with histopathological regression of cervical lesions to CIN1 or less [ Time Frame: 36 weeks ]
    The number of participants with cervical lesions regress to CIN1 or less at the 36 week visit


Secondary Outcome Measures :
  1. Number of participants with Clearance of HPV 16 or 18 in combination with histopathological regression of cervical lesions to CIN1 or less [ Time Frame: 36 weeks ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596243


Locations
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Estonia
East Tallinn Central Hospital
Tallinn, Estonia, 10119
North Estonia Medical Centre Foundation
Tallinn, Estonia, 13419
Tartu University Hospital
Tartu, Estonia, 51014
Korea, Republic of
Inje University Busan Paik Hospital
Busan, Korea, Republic of, 47392
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of, 41931
Severance Hospital
Seoul, Korea, Republic of, 03722
Cheil General Hospital & Women's Healthcare Center
Seoul, Korea, Republic of, 04619
CHA Gangnam Medical Center
Seoul, Korea, Republic of, 06135
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 06591
Hallym University Kangnam Sacred Heart Hospital
Seoul, Korea, Republic of, 07441
Ehwa Womans University Mokdong Hospital
Seoul, Korea, Republic of, 07985
Korea University Guro Hospital
Seoul, Korea, Republic of, 080308
Ukraine
Kharkiv medical academy of postgraduate education
Kharkiv, Ukraine, 61070
National Academy of Medical Sciences of Ukraine
Kyiv, Ukraine, 04050
Multi-profile Medical Center (University Clinic No. 1) of Odesa National
Odessa, Ukraine, 65026
State Institution Zaporizhzhia Medical Academy of Post-Graduate Education
Zaporizhzhya, Ukraine, 69071
Sponsors and Collaborators
Genexine, Inc.
Investigators
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Principal Investigator: Terje Raud, MD Tartu University Hospital
Principal Investigator: Kersti Kukk, MD North Estonia Medical Centre Foundation
Principal Investigator: Aira Peri, MD East Tallinn Central Hospital
Principal Investigator: Tetiana Tatarchuk, MD National Academy of Medical Sciences of Ukraine
Principal Investigator: Nataliya Lutsenko, MD State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine
Principal Investigator: Sergiy Kartashov, MD Kharkiv medical academy of postgraduate education
Principal Investigator: Natalia Rozhkovska, MD Multi-profile Medical Center (University Clinic No. 1) of Odesa National Medical University
More Information
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Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT02596243    
Other Study ID Numbers: HPV-EU-001
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017
Keywords provided by Genexine, Inc.:
CIN2, CIN2/3, CIN3
Cervical Intraepithelial Neoplasia
High-Risk HPV
HPV infection
 precancer Diseases
Double Blind
Safety/Efficacy
Additional relevant MeSH terms:
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Neoplasms
Carcinoma in Situ
Uterine Cervical Dysplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
 Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs