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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
DNA plasmid delivered via IM injection + electroporation using CELLECTRA device
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, United States
Laurel Highlands, OB/GYN, P.C.
Hopwood, Pennsylvania, United States
Clinical Research Puerto Rico
San Juan, Puerto Rico
Safety and tolerability of a fourth dose of VGX-3100
Safety and tolerability of a fourth dose of VGX-3100, administered by IM injection with EP to adult females who have been previously immunized with three doses of VGX-3100
Time frame: through Month 6 (end of study)
Humoral and cellular immune responses to VGX-3100
Humoral and cellular immune responses to VGX-3100 in blood samples obtained from study subjects after a fourth dose of VGX-3100 (6 mg) in adult female subjects who have been previously vaccinated with a three dose series of VGX-3100 containing 0.6, 2 or 6 mg of DNA/dose.
Time frame: through Month 6 (end of study)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.