Cervical Intraepithelial Neoplasia Grade 2 (CIN 2), Grade 2/3 (CIN 2/3) or Grade 3 (CIN3) MedDRA version: 19.0 Level: PT Classification code 10008263 Term: Cervical dysplasia System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Code: GX-188E
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not answered
Current Sponsor code: pGX27-E6E7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration typ
Sponsors
Genexine, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Female subjects age 18-60 years; (only, of Korea age 19-60 years); b. Histologically confirmed HPV-16 or HPV-18-associated CIN 2, CIN 2/3 or CIN 3 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; c. 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; d. 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; e. 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. Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation,symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Examples of highly effective contraception include the following: • Combined oral contraceptive pill • Contraceptive transdermal patch • Intrauterine device • Implants for contraception • Injections for contraception (with prolonged release) • Hormonal vaginal device • Sterilization, surgical tubal ligation • Sole sexual partner consisting of surgically sterilized male partner with appropriate post-surgical verification of the absence of spermatozoa in the ejaculate • Double barrier methods: condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ suppository (Note: a female condom and male condom should not be used together as friction between the two can result in either product failing) f. Able and willing to comply with all study procedures and voluntarily signs informed consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. 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; b. Pregnancy or breastfeeding; c. 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; d. History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines (e.g. Gardasil®, Cervarix®) are not excluded); e. Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV); f. Administration of any blood product within 3 months of enrollment; g. Administration of any licensed vaccine within 2 weeks of enrollment (4 weeks for measles vaccine); h. Participation in a study with an investigational compound or device within 30 days prior to signing informed consent; i. Cardiac pre-excitation syndromes (such as Wolff-Parkinson-White); j. History of seizures (unless seizure free for 5 years); k. Tattoos, scars, active lesions/rashes or any implantable leads within 3 cm of the intended site of vaccination/EP; l. Any electronic medical implants (such as cardiac pacemaker); m. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements; n. A tendency for severe haemorrhage following acute trauma; o. 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; p. Any other conditions judged by the investigator that would limit the evaluation of a subject; q. Previous randomization into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the histopathologic response to three 1 mg doses of GX-188E administered by IM injection in combination with EP delivered by TriGrid® in adult females with biopsy-proven HPV16 or 18-associated CIN 2, CIN 2/3 or CIN 3.;Secondary Objective: To evaluate the virologic response to three 1 mg doses of GX-188E administered by IM injection in combination with EP delivered by TriGrid® in adult females with biopsy-proven HPV 16 or 18-associated CIN 2, CIN 2/3 or CIN 3.;Primary end point(s): Histopathological regression of cervical lesions to CIN 1 or less.;Timepoint(s) of evaluation of this end point: 36 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clearance of HPV 16 or 18 in combination with histopathological regression of cervical lesions to CIN 1 or less.;Timepoint(s) of evaluation of this end point: 36 weeks | — |
Countries
Estonia, Georgia, Korea, Republic of, Ukraine
Contacts
Public ContactManaging Director
AS EGeen
Outcome results
None listed