A Study of VGX-3100 DNA Vaccine With Electroporation in Patients With Cervical Intraepithelial Neoplasia Grade 2/3 or 3
- Conditions
- Cervical Intraepithelial Neoplasia (CIN) 2/3 or 3MedDRA version: 17.0Level: PTClassification code 10008263Term: Cervical dysplasiaSystem Organ Class: 10038604 - Reproductive system and breast disordersTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2012-001334-33-EE
- Lead Sponsor
- Inovio Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 148
a. Female subjects age 18-55 years;
b. Histologically confirmed HPV-16 or HPV-18-associated CIN 2/3 or CIN 3 from tissue collected less than 10 weeks prior to Vaccination/EP #1 with 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; lesions in = 3 cervical quadrants (4 quadrant disease where the lesion occupies less than 50% of each quadrant will be considered for inclusion);
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 enrollment and administration of study drug;
e. Women of child-bearing potential agree to remain sexually abstinent, use two medically effective methods of contraception (e.g. oral contraception, barrier methods, spermicide, intrauterine device (IUD)), or have a partner who is sterile (i.e., vasectomy) through 36 weeks (9 months);
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 148
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 of 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, or active lesions/rashes within 2 cm of the intended site of vaccination/EP or any implantable leads;
l. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements;
m. 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;
n. Any other conditions judged by the investigator that would limit the evaluation of a subject.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the histologic response to three 6 mg doses of VGX-3100 administered by IM injection in combination with EP delivered by CELLECTRA®-5P in adult females with biopsy-proven HPV-16 or 18 associated CIN 2/3 or CIN 3;Secondary Objective: To evaluate the virologic response to three 6 mg doses of VGX-3100 administered by IM injection in combination with EP delivered by CELLECTRA®-5P in adult females with biopsy-proven HPV-16 or 18 associated 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 Outcome Measures
Name Time Method 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