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  • DNA vaccine VGX-3100 with electroporation induces regression of cervical intraepithelial neoplasia 2/3 and clears HPV infection with robust T cell responses: results of a randomized, double-blind, placebo-controlled Phase II trial

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DNA vaccine VGX-3100 with electroporation induces regression of cervical intraepithelial neoplasia 2/3 and clears HPV infection with robust T cell responses: results of a randomized, double-blind, placebo-controlled Phase II trial
  1. Laurent Humeau1,
  2. Cornelia Trimble2,
  3. Matthew Morrow1,
  4. Xuefei Shen1,
  5. Michael Dallas1,
  6. David Weiner3,
  7. Jean Boyer3,
  8. Jian Yan1,
  9. Kimberly Kraynyak1,
  10. Albert Sylvester1,
  11. Mary Giffear1,
  12. Kathy Marcozzi-Pierce1,
  13. Divya Shah1,
  14. Kate Broderick1,
  15. Amir Khan1,
  16. Jessica Lee1,
  17. Niranjan Sardesai1,
  18. Mark Bargarazzi1,
  19. the HPV-003 Protocol team1
  1. Aff1 grid.421774.3Inovio Pharmaceuticals USA
  2. Aff2 grid.21107.350000000121719311Johns Hopkins Baltimore MD USA
  3. Aff3 grid.25879.310000000419368972Perelman School of Medicine University of Pennsylvania PA USA

https://doi.org/10.1186/2051-1426-2-S3-O17

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    Meeting abstracts

    The Phase II study, designated HPV-003 (NCT01304524), assessed the safety and efficacy of VGX-3100 in 167 women with biopsy-proven cervical intraepithelial neoplasia (CIN) 2 or CIN 3 and HPV-16 or -18. The randomized, placebo-controlled, double-blind study, was stratified by age and severity of CIN and evaluated cervical tissue changes after three 6 mg intramuscular doses of the DNA vaccine VGX-3100 followed by electroporation (EP) with Inovio's CELLECTRA® 2000 device at weeks 0, 4, and 12. Cervical tissue was examined before starting blinded treatment and ~9 months later. The primary endpoint was regression of CIN 2 or CIN 3 to CIN 1 or no disease at 6 months post third dose. In the per-protocol population (PPP), lesions regressed in 53 of the 107 women receiving VGX-3100 (49.5%) as compared to 11 of the 36 women in the placebo group (p < 0.025). The secondary endpoint was to demonstrate HPV-16 or -18 clearance from the cervix in conjunction with regression of CIN 2/3 to CIN1 or no disease. Among the 107 women in the VGX-3100 group, 43 demonstrated regression and virological clearance (40.2%), compared to 5 out of 35 (14.3%) in the placebo group (p < 0.025).

    The study also explored cell mediated immune responses to VGX-3100 in blood samples taken prior to the first vaccine dose and periodically thereafter. IFN-γ ELISpot results revealed higher responses in the VGX-3100 treated group than in the placebo group. Flow cytometry and immunohistochemistry analyses are also ongoing. Finally, subjects were also monitored for tolerability and safety. The treatment was generally well-tolerated, with only administration site redness occurring significantly more frequently in the VGX-3100 group compared to the placebo group in the 7- and 28-day periods following treatment.

    Altogether, the successful Phase II results clearly illustrate the highly promising potential of therapeutic vaccination with DNA followed by electroporation for the treatment of HPV-related precancerous cervical disease in women as well as HPV-associated cervical, head and neck, and anogenital cancers.