Abstract: The invention provides for anti-pathogen vaccines produced in recombinant bacteria and/or transgenic plants and administered through standard vaccine introduction methods or oral administration. In one embodiment, the vaccine is administered through the consumption of the edible plant as food, or the bacteria administered orally. The present invention also provides a method of using genetically modified microorganisms, such as lactic acid bacteria, including Lactococcus lactis strains, as oral vaccines. In one embodiment, Lactococcus lactis expressing the avian influenza HA gene can be used as an oral vaccine for protection against H5N1 virus infection. In another embodiment, said Lactococcus lactis is administered as an oral vaccine in conjunction with an adjuvant such as cholera toxin B.

Abstract: In one embodiment, the present invention provides for an edible mini-capsule form of live, non-persisting, recombinant Lactococcus lactis (L. lactis) vaccine against a pathogen such as the highly virulent influenza H5N1 strain. Enteric coated capsule of the present invention induced high levels of hemagglutinin-specific serum IgG and fecal IgA antibody production after oral administration in mice and chickens, and rendered complete protection against a lethal challenge of H5N1 virus in mice. The present invention thus demonstrates a broadly applicable platform technology for producing and administering edible vaccines against bacterial and viral infections.

Abstract: The anti-pathogen vaccine of the present invention is produced in recombinant bacteria and/or transgenic plants and then administered through standard vaccine introduction method or through the oral administration. A DNA sequence encoding for the expression of an antigen of a pathogen is isolated and ligated to a promoter which can regulate the production of the surface antigen in a bacterial or transgenic plant. Preferably, a foreign gene is expressed in a portion of the plant or bacteria, and all or part of the antigen expressing plant or bacteria used for vaccine administration. In a preferred procedure, the vaccine is administered through the consumption of the edible plant as food, or the bacteria administered orally. The present invention also provides a method of using genetically modified microorganisms generally recognized to be edible and/or harmless to animals or humans when ingested, such as lactic acid bacteria, including Lactococcus lactis strains, as oral vaccines.