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

PHASE2CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

May 15, 2018

Primary Completion Date

June 16, 2020

Study Completion Date

May 26, 2021

Conditions
Anal Neoplasm
Interventions
BIOLOGICAL

VGX-3100

One milliliter (1 mL) VGX-3100 (deoxyribonucleic acid \[DNA\] plasmids encoding E6 and E7 proteins of HPV types 16 and 18) will be injected IM and delivered by EP using CELLECTRA™ 5PSP on Day 0, Week 4 and Week 12, and potentially Week 40.

DEVICE

CELLECTRA™ 5PSP

IM injection of VGX-3100 is followed by EP with the CELLECTRA™ 5PSP device.

Trial Locations (3)

10011

Laser Surgery Care, New York

60613

Howard Brown Health (HBH)-Sheridan, Chicago

G1S2L6

Clinique de Recherche en Sante, Québec

Sponsors
All Listed Sponsors
lead

Inovio Pharmaceuticals

INDUSTRY

NCT03499795 - 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 | Biotech Hunter | Biotech Hunter