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Phase I of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation for CIN 2 or 3 - NCT00685412-27103(Clinical Trial 223023)



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City:  Winston-Salem
State:  
NC
Zip Code: 27103
Conditions: Papillomavirus Infections
Purpose: 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.
Study summary:
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.
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Data Source: ClinicalTrials.gov
Date Processed: May 21, 2010
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