Testing for Safety and Immune Effects of PDS0101, an Anti-HPV Therapy, Among People Living With HIV

PDS0101 is an HPV 16-targeted immunotherapy administered as two subcutaneous injections of 0.5 mL each (total 1.0 mL). Each dose contains 3.0 mg of Versamune®, a proprietary cationic lipid nanoparticle adjuvant, and 2.7 mg of HPVmix, a blend of HPV16 E6 and E7 proteins. Versamune® enhances antigen uptake and dendritic cell activation, promoting T-cell priming and memory formation. In preclinical studies, subcutaneous administration resulted in low systemic bioavailability (\<6%) and efficient dendritic cell uptake, consistent with a favorable safety profile. PDS0101 has been studied in a completed Phase I trial in HIV-uninfected women with high-risk HPV and cervical intraepithelial neoplasia (CIN) I. Each participant in this study will receive three doses, spaced 21 days apart (± 7 days) unless there has been Grade 3 or greater toxicity at least possibly related to the study agent.