a study of vgx-3100 dna vaccine with electroporation in patients with cervical intraepithelial neoplasia grade 2/3 or 3

Conditions: Cervical Intraepithelial Neoplasia

Summary: this is randomized, placebo controlled study to determine safety and efficacy of vgx-3100 dna vaccine delivered by electroporation to adult women with biopsy-proven hpv 16 or 18 associated cervical intraepithelial neoplasia grade 2/3 or 3.


Eligibility criteria:
inclusion criteria: * female subjects age 18-55 years; * 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; * 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); * 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; * 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); * 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( 4weeks for measles vaccine) * participation in a study with an investigational compound or device within 30 days of signing informed consent; * cardiac pre-excitation syndromes (such as wolff-parkinson-white); * history of seizures (unless seizure free for 5 years); * tattoos, scars, or active lesions/rashes within 2 cm of the intended site of vaccination/ep or any implantable leads; or any implantable leads; * active drug or alcohol use or dependence that, in the opinion of the investigator,would interfere with adherence to study requirements; * 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; * any other conditions judged by the investigator that would limit the evaluation of a subject

Keywords: cin 2/3 or cin 3 cervical cancer papillomavirus