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

NCT ID: NCT02596243

Last Updated: 2017-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-08-31

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

Conditions

Cervical Intraepithelial Neoplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

GX-188E

GX-188E + EP

Group Type: EXPERIMENTAL

GX-188E

Intervention Type: BIOLOGICAL

1mg of GX-188E administered IM using EP device at day 0, week 4 and week 12.

placebo

Placebo + EP

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

0.5mL of Placebo administered IM using EP device at day 0, week 4 and week 12.

Interventions

GX-188E

1mg of GX-188E administered IM using EP device at day 0, week 4 and week 12.

Intervention Type: BIOLOGICAL

Placebo

0.5mL of Placebo administered IM using EP device at day 0, week 4 and week 12.

Intervention Type: BIOLOGICAL

Other Intervention Names

DNA therapeutic vaccine; Placebo-control

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genexine, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terje Raud, MD

Role: PRINCIPAL_INVESTIGATOR

Tartu University Hospital

Kersti Kukk, MD

Role: PRINCIPAL_INVESTIGATOR

North Estonia Medical Centre Foundation

Aira Peri, MD

Role: PRINCIPAL_INVESTIGATOR

East Tallinn Central Hospital

Tetiana Tatarchuk, MD

Role: PRINCIPAL_INVESTIGATOR

National Academy of Medical Sciences of Ukraine

Nataliya Lutsenko, MD

Role: PRINCIPAL_INVESTIGATOR

State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine

Sergiy Kartashov, MD

Role: PRINCIPAL_INVESTIGATOR

Kharkiv medical academy of postgraduate education

Natalia Rozhkovska, MD

Role: PRINCIPAL_INVESTIGATOR

Multi-profile Medical Center (University Clinic No. 1) of Odesa National Medical University

Locations

East Tallinn Central Hospital

Tallinn, , Estonia

North Estonia Medical Centre Foundation

Tallinn, , Estonia

Tartu University Hospital

Tartu, , Estonia

Inje University Busan Paik Hospital

Busan, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Severance Hospital

Seoul, , South Korea

Cheil General Hospital & Women's Healthcare Center

Seoul, , South Korea

CHA Gangnam Medical Center

Seoul, , South Korea

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, , South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, , South Korea

Ehwa Womans University Mokdong Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

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

Odesa, , Ukraine

State Institution Zaporizhzhia Medical Academy of Post-Graduate Education

Zaporizhzhya, , Ukraine

Countries

Estonia; South Korea; Ukraine

Other Identifiers

HPV-EU-001

Identifier Type: -

Identifier Source: org_study_id