VaxiSome® is based on a synthetic polycationic sphingolipid derived from D-erythro ceramide to which spermine is covalently attached, thereby forming Ceramide Carbamoyl Spermine (CCS). CCS mixed with cholesterol (CCS/C) self-assembles into liposomes known as VaxiSome. Based on its structure and components (ceramide, CO2 and spermine), CCS is predicted to be biocompatible and biodegradable. Being fully synthetic gives CCS advantages relative to many other adjuvants. VaxiSome is a potent liposomal adjuvant for stimulating enhanced immune responses via dual Th1/Th2 activities that augment antibody and cell-mediated responses, VaxiSome should be a useful adjunct to immunotherapeutic applications such as cancer and AD. Preclinical studies have shown that VaxiSome-Influenza is significantly more immunogenic than two commercial adjuvanted influenza vaccines. Preclinical studies with adjuvanted hepatitis B, anthrax and pandemic flu vaccine antigens have demonstrated increased potency. The adjuvant effect of VaxiSome for increasing antibody titers was apparent in two Phase 1/2a clinical studies of intramuscular commercial influenza vaccine (VaxiSome-Influenza), but was not apparent in the two other studies. All clinical studies showed the adjuvant effect of longer duration of HI titers between 1 and 3 months of follow-up post-vaccination. The adjuvanted vaccine generally has been well tolerated in all studies, with no significant systemic effects. Injection site effects were transient, VaxiSome®-dose-related, and generally of the same type as seen with other adjuvanted vaccines.