phase i of human papillomavirus (hpv) dna plasmid (vgx-3100) + electroporation for cin 2 or 3

Conditions: Papillomavirus Infections

Summary: dna vaccines, which are small pieces of dna also known as plasmids, have several advantages over traditional vaccines such as live attenuated virus and recombinant protein-based vaccines. dna vaccines appear to be well tolerated in humans. therefore, we have developed our dna vaccine, vgx-3100, to include plasmids targeting e6 and e7 proteins of both hpv subtypes 16 and 18. we have chosen to deliver our candidate vaccines via electroporation (ep) using the cellectra™ constant current device to deliver a small electric charge following intramuscular (im) injection, since animal studies have shown that this delivery method increases the immune response to our dna vaccine leading to a decrease in the size of tumors caused by hpv 16 and 18. the vaccine is proposed to be given to patients with a history of cin 2 and 3 that have been treated by surgery. we will determine which dose the dna vaccine will be the best tolerated and elicit the strongest immune response.


Eligibility criteria:
inclusion criteria: * written informed consent in accordance with institutional guidelines; * female 18-45 years of age; * post surgical (including leep and conization) or ablative treatment and a diagnosis of cin 2 or 3, while under physician care as per asccp guidelines (appendix d); * normal ecg and normal laboratory values as judged by grade 0-1 as per toxicity grading scale for healthy adults (appendix c) for cbc, cpk, sma-12 and urinalysis evaluations done up to 30 days prior to administration of study treatment; * body mass index (bmi) ≤30 kg/m2; * women of child-bearing potential (wocbp) agree to remain sexually abstinent, use medically effective contraception (oral contraception, barrier methods, spermicide, etc), or have a partner who is sterile (i.e., vasectomy) from enrollment to 3 months after the last injection (\~6 months); * able and willing to comply with all study procedures. exclusion criteria: * active infection with herpes simplex virus (hsv); * positive serological test for hiv virus, hepatitis c virus or hepatitis b virus surface antigen (hbsag); * pregnant or breastfeeding subjects; * any concurrent condition requiring the continued use of systemic or topical steroids (excluding inhaled and eye drop-containing corticosteroids) or the use of immunosuppressive agents. all other corticosteroids must be discontinued \> 4 weeks prior to day 1 of treatment;; * administration of any blood product within 3 months of enrollment; * administration of any vaccine within 6 weeks of enrollment; * patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent; * metal implants at the site of injection; * 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 or 3 cervical cancer