VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High Grade Squamous Intraepithelial Lesion (HSIL) in Individuals Seronegative for Human Immunodeficiency Virus (HIV)-1/2

Anal Neoplasm Clinical Trial

Official title: A Phase 2, Open Label, Study of VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High Grade Squamous Intraepithelial Lesion (HSIL), (AIN2, AIN3, PAIN2, PAIN3) in Individuals That Are Seronegative for Human Immunodeficiency Virus (HIV)-1/2

Status Completed

Clinical Trial Summary

This is a phase 2, open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in adult men and women who are human immunodeficiency virus (HIV) negative with histologically confirmed anal or anal/peri-anal high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus (HPV)-16 and/or HPV-18. Approximately 24 participants will receive at least 3 doses of VGX-3100.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Anal Neoplasm
• Anus Neoplasms
• Carcinoma in Situ
• Carcinoma, Squamous Cell
• HIV Infections
• Squamous Intraepithelial Lesions of the Cervix

• NCT number: NCT03499795
• Study type: Interventional
• Source: Inovio Pharmaceuticals
• Status: Completed
• Phase: Phase 2
• Start date: May 15, 2018
• Completion date: May 26, 2021