UnknownPhase 2

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

Estonia, South Korea134 participantsStarted 2015-08

Plain-language 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)

Who can participate

Age range18 Years – 60 Years

SexFEMALE

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Inclusion criteria

✓. Female subjects age 18-60 years
✓. 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;
✓. 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;
✓. 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;
✓. 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.
✓. Able and willing to comply with all study procedures and voluntarily signs informed consent form.

Exclusion criteria

✕. 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;
✕. Pregnancy or breastfeeding;
✕. 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;
✕. History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines (e.g. Gardasil®, Cervarix®) are not excluded);
✕. Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV);
✕. Administration of any blood product within 3 months of enrollment;
✕. Administration of any licensed vaccine within 2 weeks of enrollment (4 weeks for measles vaccine);
✕. Participation in a study with an investigational compound or device within 30 days prior to signing informed consent;

What they're measuring

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

Timeframe: 36 weeks

Trial details

NCT IDNCT02596243

SponsorGenexine, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-03

View on ClinicalTrials.gov More Cervical Intraepithelial Neoplasia trials