Phase I of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation for CIN 2 or 3 - Trial NCT00685412
Access comprehensive clinical trial information for NCT00685412 through Pure Global AI's free database. This Phase 1 trial is sponsored by Inovio Pharmaceuticals and is currently Completed. The study focuses on Papillomavirus Infections. Target enrollment is 18 participants.
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Study Focus
Sponsor & Location
Inovio Pharmaceuticals
Timeline & Enrollment
Phase 1
May 01, 2008
Mar 01, 2011
Primary Outcome
Safety and tolerability of escalating doses of VGX-3100, administered by IM injection with EP to adult female subjects post surgical or ablative treatment of grade 2 or 3 CIN.
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT00685412
Non-Device Trial