At a glance
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A Phase 2 Evaluation of VGX-3100, a Synthetic DNA Immunotherapy Targeting Human Papillomavirus 16 and 18 E6 and E7 Proteins, for Anal High-Grade Squamous Intraepithelial Lesions (HSIL) in HIV-Positive Individuals
In Brief
A Phase 2 clinical trial evaluating Electroporation, HPV DNA Plasmids Therapeutic Vaccine VGX-3100, and 1 other intervention for Anal Intraepithelial Neoplasia and 4 related conditions. Completed, enrolled 44 participants across 8 sites in 2 countries.
Detailed Summary
This phase II trial studies the use of human papillomavirus (HPV) deoxyribonucleic acid (DNA) plasmids therapeutic vaccine VGX-3100 (VGX-3100) and electroporation in treating patients with human immunodeficiency virus (HIV)-positive high-grade anal lesions. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells. Electroporation helps pores in your body's cells take in the drug to strengthen your immune system's response. Giving VGX-3100 and electroporation together may work better in treating patients with high-grade anal lesions.
Study Details
Timeline
Interventions
Undergo electroporation
Given IM
Correlative studies