Phase I clinical study for validation of photochemical internalisation (fimaVacc): a novel technology for enhancing cellular immune responses important for therapeutic effect of peptide- and protein-based vaccines (Conference Presentation)

In the fimaVacc technology photochemical internalization (PCI) is employed for enhancing cytotoxic T-cell responses to vaccination. Thus, in pre-clinical studies fimaVacc has been shown to increase MHC class I antigen presentation, leading to strongly enhanced cytotoxic- and helper T-cell responses to various types of vaccines. On the basis of promising preclinical results, a phase I clinical study with fimaVacc has been performed in healthy volunteers. FimaVacc involves formulating the vaccine with a photosensitising compound (fimaporfin) and a toll-like receptor (TLR) agonist. The vaccine is given as intradermal injections followed by illumination of the vaccination site. Results from a phase I clinical study in healthy volunteers will be presented. The subjects were vaccinated with models for peptide- and protein-based vaccines; HPV16 E7 peptide antigens and Keyhole Limpet Hemocyanin. Both antigens were formulated with the TLR3 agonist poly-ICLC (Hiltonol), and up to three vaccinations were be given. Local and systemic adverse effects will be assessed, and cellular and humoral immune responses were analysed by ELISPOT and ELISA assays, and by flow cytometry.