STUDY OF VGX-3100 DELIVERED IM FOLLOWED BY ELECTROPORATION (EP) FOR THE TREATMENT OF CIN 2/3 OR CIN 3 WITH HPV 16 OR 18
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0000284
- Lead Sponsor
- Inovio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- 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 a biopsy less than 8 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;
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 (oral contraception, barrier methods, spermicide, etc), 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
a.Colposcopy is unsatisfactory AND an endocervical curette (ECC) specimen identifies endocervical CIN that is not directly visualized and therefore not amenable to adequate colposcopic follow-up evaluations;
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;
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 site of vaccination/EP or any subject who has implanted metallic material;
l.Subjects who have a history of severe allergic reaction or hypersensitivity reaction;
m.Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements;
n.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;
o.Any other conditions judged by the investigator that would limit the evaluation of a subject.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The histopathologic response to three 6 mg doses of VGX-3100 administered by IM injection in combination with CELLECTRA
- Secondary Outcome Measures
Name Time Method Virologic response to three 6 mg doses of VGX-3100 administered by IM injection in combination with CELLECTRA;HLA types and correlation to immune response;humoral and cellular immune responses ;local immune responses in cervical samples