The invention offered for licensing provides methods and compositions for induction of an antigen-specific, mucosal cytotoxic T lymphocyte (CTL) response useful in preventing and treating infections with pathogens that gain entry via a mucosal surface. The methods of the invention involve administering either a soluble antigen itself, or a polynucleotide encoding the soluble antigen, to a mucosal surface. The soluble antigens can be full length, naturally occurring polypeptides or fragments (i.e. peptides) derived from them. The soluble antigen is administered with an adjuvant at the mucosal site or without an adjuvant. Adjuvants can be, for example, Cholera toxin (CT), mutant CT (MCT), E. coli heat labile enterotoxin (LT) and others. Cytokines like IL-12 or IFNgamma can also be administered to enhance the immunoreactivity. Mucosal routes of administration include intrarectal (IR), intranasal (IN), intragastric (IG), intravaginal (IVG) or intratratracheal (IT). Soluble antigens can be derived from pathogenic viruses (e.g. HIV, influenza, or hepatitis virus), bacteria (e.g. Listeria monocytogenes), or prozoans. Furthermore, the soluble antigen can be tumor-associated antigen for cancer applications.

The utility of the technology has been extensively demonstrated when applied to HIV. Details about the HIV studies are provided in the eight (8) publications cited below. 0