Abstract: Methods and compositions are provided for in vivo heterologous nucleic acid delivery using genetically modified microflora. Specifically, compositions and related methods for the delivery of heterologous nucleic acids to the intestinal mucosa of animals are provided. Specifically, genetically modified microflora are used to deliver transforming heterologous nucleic acids directly, or genetically modified microflora expressing at least one heterologous nucleic acid are provided. Representative microflora include bacteria, bacterial fusions, and yeast. The heterologous nucleic acid may encode for immunoprotective epitopes (antigens) or other gene therapy applications.

Abstract: Clinical grade vectors comprising transformed microflora vector having at least one transforming nucleic acid sequence containing at least one gene of interest are provided. The transforming nucleic acid encodes for a therapeutic polypeptide that is delivered to the host in need thereof topically, orally, intranasally and/or transderamally. The clinical grade vectors are derived from lactic acid bacteria, yeast and other non-pathogenic microorganisms and have been provided with selective/and or reporter genes that do not rely on antibiotic resistance. Moreover, the clinical grade vectors are provided with phenotypic and/or genotypic traits that limit the ex vivo dissemination of transforming nucleic acid sequence(s). Also provided are methods and compositions useful in treating diseases in animals.

Abstract: Methods and compostions related to the fields of bacteriology, immunology and gene therapy are provided. In general modified microflora for the delivery of vaccines, allergens and therapeutics to the mucosal surfaces of the respiratory tract are provided. In particular, the compositions and methods are directed at inducing an M-cell mediated immune response to pathogenic diseases. Specifically, methods of vaccine preparation, delivery and mucosal immunization using a Lactic Acid Bacteria (LAB), yeast and LAB that have been modified through fusion with E. coli to either present on its cell surface, or secrete, antigenic epitopes derived from pathogenic microorganisms and/or to secrete a therapeutic protein sequence are disclosed.