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

Brief Title

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)

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
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Number of participants with histopathological regression of cervical lesions to CIN1 or less

Secondary Outcome

 Number of participants with Clearance of HPV 16 or 18 in combination with histopathological regression of cervical lesions to CIN1 or less

Condition

Cervical Intraepithelial Neoplasia

Intervention

GX-188E

Study Arms / Comparison Groups

 GX-188E

Description:  GX-188E + EP

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

134

Start Date

August 2015

Completion Date

August 2018

Primary Completion Date

March 2018

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.
      

Gender

Female

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Terje Raud, MD, , 

Location Countries

Estonia

Location Countries

Estonia

NCT ID

NCT02596243

Organization ID

HPV-EU-001

Responsible Party

Sponsor

Study Sponsor

Genexine, Inc.

Study Sponsor

Terje Raud, MD, Principal Investigator, Tartu University Hospital

Verification Date

July 2017