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NCT00685412

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

Phase I Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Immunogenicity of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation (EP) in Adult Females Post Surgical or Ablative Treatment of Grade 2 or 3 Cervical Intraepithelial Neoplasia (CIN)
Inovio Pharmaceuticals·Phase 1·ClinicalTrials.gov·biologicalCompleted
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Study focus
Disease/Condition
Papillomavirus Infections
Drug/Device/Intervention
VGX-3100
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Inovio Pharmaceuticals
Location
Winston-Salem,Hopwood,Philadelphia,San Juan, Puerto Rico,United States of America
Timeline & enrollment
Phase
Phase 1
Start date
May 01, 2008
End date
Mar 01, 2011
Enrollment
18 participants
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
Papillomavirus as the cause of diseases classified to other chaptersPapovavirus infection, unspecified sitePapilloedema, unspecifiedViral infection, unspecifiedParvovirus as the cause of diseases classified to other chapters
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT00685412
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.