Fourth Dose of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + EP in Adult Females Previously Vaccinated With Three Doses of VGX-3100

Human Papillomavirus (HPV) Clinical Trial

Official title:
Phase I, Open-label Study to Evaluate the Safety, Tolerability and Immunogenicity of a Fourth Dose of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation (EP) in Adult Females Previously Immunized With VGX-3100

Status Completed

Clinical Trial 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, the investigators have developed our DNA vaccine, VGX-3100, to include plasmids targeting E6 and E7 proteins of both HPV subtypes 16 and 18. The investigators 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. In study HPV-001, the vaccine was given to subjects with a history of CIN 2 and 3 who had been previously treated by surgery. This study is proposed to vaccinate the same subjects with a fourth dose of the VGX-3100 to determine the safety and immune response.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Human Papillomavirus (HPV)

Clinical Trial Details

NCT number	NCT01188850
Study type	Interventional
Source	Inovio Pharmaceuticals
Contact
Status	Completed
Phase	Phase 1
Start date	July 2010
Completion date	October 20, 2011

View Details

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