Priming of CD4+ and CD8+ T cell responses using a HCV core ISCOMATRIX vaccine: a phase I study in healthy volunteers.

The disease burden and public health impact of chronic HCV infection continues to be a major problem globally. Current treatment for chronic HCV infection is not effective in all patients and is frequently associated with unacceptable side effects. Clearly a need exists for improved treatments and one such strategy is the use of therapeutic vaccines. Although still not completely understood, emerging data indicate that the generation of CD4+ and CD8+ T cells are important for the clearance of HCV. We have developed a prototype vaccine with the HCV Core protein and ISCOMATRIX™ adjuvant (HCV Core ISCOMATRIX™ vaccine). ISCOMATRIX™ vaccines have been shown to induce CD4+ and CD8+ T cell responses to a range of antigens in both animal models and in human studies. Additionally, ISCOMATRIX™ vaccines have been shown to be safe and generally well tolerated in several clinical trials. Preliminary studies demonstrated that the prototype HCV Core ISCOMATRIX™ vaccine induced strong CD4+ and CD8+ T cell responses in mo...