Phase I/IIa study of therapeutic p16INK4a vaccination in patients with HPV-associated cancers.

3097 Background: Therapeutic strategies specifically targeting HPV-associated cancers are lacking. The cellular protein p16INK4a is strongly overexpressed in HPV-associated cancers, while in normal tissues p16INK4a expression is barely detectable. Therefore targeting of p16INK4a by vaccination could represent an interesting immune therapeutic approach for patients with HPV-associated cancers. We performed a phase I/IIa trial to monitor toxicity and immunogenicity of p16INK4avaccination (Vicoryx). Methods: Patients with advanced p16INK4a-overexpressing, HPV DNA-positive cancer (anogenital region, head and neck) were included after completion of standard treatment. The protocolcomprised a total of 12 subcutaneous injections of a synthetic p16INK4 peptide mixed with Montanide ISA-51 VG in weekly intervals. Objectives of the trial were clinical safety and changes of humoral and cellular immune responses against the p16INK4apeptide. T cell responses were monitored by interferon-gamma ELISpot and antibodies by ...