We have used liposomal emulsions in studies with both mice and in humans. PSA, KSA, kallikrein, anthrax protective antigen, and HIV gp140 have been used as antigen in mice (28,30). High titers of antibodies and potent cellular immunity were induced in mice. The antibody responses tended to be reduced below those obtained with liposomes alone. Cellular immune responses were similar to those obtained with liposomes alone. In contrast, immunization of prostate cancer patients with liposomes containing PSA and lipid A induced minimal to no antibody or cellular immune responses (2,20). This was quite surprising because immunization with Walter Reed liposomes induced very strong immune responses in clinical trials for malaria and HIV vaccine (24,25,61). Vaccine research in prostate cancer patient represented a very challenging context for research. The patients were at the final stage, having failed all other conventional therapies, immu-nosuppressed, and had high levels of circulating PSA. In phase I clinical trials, immunization of the prostate cancer patients with liposome-encapsulated PSA formulated in an oil-in-water emulsion induced immune responses, either high titer antibody or cellular immune responses, or both, in 100% of the patients immunized. Thus, it appears that liposomal emulsions are potent adjuvant formulations for humans, but are not particularly effective (i.e., not better than liposomes by themselves) in mice. The ability of the liposomal emulsions to induce strong immune responses in other animals remains to be demonstrated. In summary, we have developed and described the manufacture of an adjuvant system using a liposomal emulsion that induces potent immune responses in humans.
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