Despite advances in knowledge, screening, preventive vaccination, and surgical treatment, HPV remains the most prevalent sexually transmitted illness in the world. VGX-3100 is an immunotherapy that employs electroporation to deliver DNA encoding for modified HPV-16 and HPV-18, E6- and E7 proteins into myocytes in order to trigger an effector T cell response. The study also reports on the immunogenicity and safety of VGX-3100 in a refrigeration-stable formulation, which increases patient-care setting use. This multi-arm, double-blind, randomised study recruited 235 healthy men and women who were randomly assigned to either a refrigerated (RF) or frozen formulation (FF) of VGX-3100. At 0, 4, and 12 weeks, three dosages were given intramuscularly by electroporation. The non-inferiority of RF to FF was determined by comparing the proportion of individuals who obtained a 2-fold increase in Spot Forming Units/106 PMBCs from baseline to Week 14 using an interferon-enzyme-linked immunospot assay. The most prevalent adverse event was injection site responses, the majority of which disappeared within a few minutes after treatment. The main objective was attained, with 89.9% of RF recipients and 97.2 percent of FF recipients achieving a 2-fold increase in SFU/106 PBMC 2 weeks after the last treatment; RF was statistically non-inferior to FF.

A systemic, immunological strategy can address a major gap in men’s and women’s capacity to treat high-grade HPV infections. These results on safety and immunogenicity encourage the further development of a cooled VGX-3100 formulation.