Vaccine Info

VGX-3100 HPV

VGX-3100 is an investigational immunotherapy designed to treat pre-cancers and cancers caused by human papillomavirus (HPV).

VGX-3100 includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18. VGX-3100 is delivered intramuscularly using the CELLECTRA® 5PSP delivery device.

CLINICAL TRIALS:

Cervical HSIL

  • A persistent HPV infection can lead to high-grade squamous intraepithelial lesions (HSIL) in cervical cells. HPV types 16 and 18 cause 70% of cervical cancer cases. In the US and EU5 countries, there are approximately 3.4 million incidences of low-grade and high-grade cervical precancers.
  • VGX-3100 was the first therapeutic vaccine to demonstrate efficacy against cervical HSIL associated with HPV-16 and HPV-18. 
  • Clinical Trial Phase 3 NCT03721978: REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

Vulvar HSIL

  • A persistent infection with HPV can lead to the development of high-grade squamous intraepithelial lesions (HSIL) in vulvar cells.   
  • Based on promising results in treating cervical HSIL, VGX-3100 is being used to treat patients with vulvar HSIL in an ongoing Phase 2 trial.
  • This is a randomized, open-label study of VGX-3100 alone or in combination with imiquimod in patients with HPV-16 and/or HPV-18 related vulvar HSIL.
  • Clinical Trial Phase 2 NCT03180684: Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL

Anal HSIL

  • A persistent infection with HPV can lead to the development of high-grade squamous intraepithelial lesions (HSIL) in anal and/or peri-anal cells.  These lesions can lead to anal cancer.
  • Based on promising results in treating cervical HSIL, VGX-3100 is being used to treat patients with anal HSIL in an ongoing Phase 2 trial. 
  • This is an open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in adult men and women who are HIV negative with histologically confirmed anal or anal/peri-anal high-grade squamous intraepithelial lesion (HSIL) associated with human papillomavirus (HPV)-16 and/or HPV-18.
  • Clinical Trial Phase 2 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
Updated
April 19th, 2019